anurajms/meta_analysis huggingface dataset:
primary outcome:
Advance misoprostol distribution to pregnant women for preventing and treating postpartum haemorrhage
Severe PPH (at least 1000 mL, or as defined by authors)Serious maternal morbidity (organ failure, hysterectomy, intensive care unit admission, or as defined by authors)Maternal death
primary outcome:
Anaesthesia/analgesia for manual removal of retained placenta
Pain intensity – using validated rating measures, such as a Visual Analogue Scale (VAS), Numerical Rating Scale (NRS), Verbal Rating Scale (VRS), or the Faces Pain Scale‐Revised (FPS‐R)Adverse events (considered as separate outcomes, e.g. febrile morbidity, hypotension, cardiac arrhythmias, aspiration, respiratory depression requiring oxygen administration, headache, nausea or vomiting, urinary retention)
primary outcome:
Strategies for optimising antenatal corticosteroid administration for women with anticipated preterm birth
Perinatal death (as defined by trial authors)Offspring mortality*, early neurodevelopmental morbidity*, or late neurodevelopmental morbidity* (composite outcome)
primary outcome:
Aspirin or heparin or both for improving pregnancy outcomes in women with persistent antiphospholipid antibodies and recurrent pregnancy loss
Live birthLive birth
primary outcome:
Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections
Post‐cesarean endometritis: defined as a clinical diagnosis, usually involving fever, uterine fundal tenderness, or purulent lochia requiring antibiotic therapy.
primary outcome:
Antibiotic prophylaxis for operative vaginal delivery
Fever (body temperature of 38 degrees celsius or higher) occurring on any two occasions in the first 10 days postpartum, exclusive of the first 24 hoursInfected episiotomy/perineal/vaginal laceration (oedematous, erythematous, wound edge with pain, serosanguineous or frankly purulent material or wound dehiscence)Endometritis (fever and uterine tenderness or heavy bleeding)Urinary tract infection (fever or dysuria and positive urine culture)Serious infectious complications (such as bacteraemia, systemic infection, septic shock, septic thrombophlebitis, necrotising fasciitis or death attributed to infection)Confirmed or suspected maternal infection within six weeks of delivery, defined by a new prescription of antibiotics for presumed perineal wound‐related infection, endometritis or uterine infection, urinary tract infection with systemic features or infection; confirmed systemic infection on culture; or endometritis (non‐prespecified)
primary outcome:
Pharmacological interventions for promoting smoking cessation during pregnancy
Self‐reported abstinence from smoking at the latest time point in pregnancy at which this was measured and, where available, validated biochemically using measures such as exhaled carbon monoxide, saliva cotinine, or, in those who are not smoking but using nicotine (e.g. from NRT or ECs), anabasine. When validated abstinence data were available, these were preferred to self‐report. Where this information was available, we also used prolonged or continuous abstinence measures, timed from a quit date set in early pregnancy and which allowed temporary lapses to smoking as per the Russell Standard criteria for outcome measurement in cessation studies (West 2005). However, point prevalence abstinence measures were substituted for these as required.
primary outcome:
Progestogen for preventing miscarriage in women with recurrent miscarriage of unclear etiology
Miscarriage ‐ defined by trial authors but typically as pregnancy loss less than 20 weeks' gestation
primary outcome:
Antiplatelet agents for preventing pre‐eclampsia and its complications
For trials with IPD, outcomes were defined using the PARIS 2005 definitions. For trials with only AD available, the trialists' own outcome definitions were used.
primary outcome:
Cervical assessment by ultrasound for preventing preterm delivery
Preterm birth (less than 37 weeks for singleton pregnancies; less than 34 weeks for twin pregnancies)
primary outcome:
Interventions for supporting the initiation and continuation of breastfeeding among women who are overweight or obese
Non‐initiation of breastfeeding ‐ where initiation is defined as the baby being put to the breast or being given any of the mother's breast milk within 48 hours of delivery (NHS England 2014)Exclusive breastfeeding at four to six weeks ‐ as defined by trial authorsAny breastfeeding at four to six weeksExclusive breastfeeding at six months ‐ as defined by trial authorsAny breastfeeding at six months
primary outcome:
Effect of timing of umbilical cord clamping and other strategies to influence placental transfusion at preterm birth on maternal and infant outcomes
We searched the COMET database (http://www.comet‐initiative.org/) to see if a core outcome set (COS) had been developed for outcomes in preterm birth. We only found reference to COS for preventing preterm birth in the CROWN Initiative (http://www.crown‐initiative.org/tag/preterm‐birth/) and also in a further publication on prevention of preterm birth (Meher 2014). We have, therefore, in discussion amongst co‐authors chosen the primary and secondary outcomes below.
primary outcome:
Fetal fibronectin testing for reducing the risk of preterm birth
(1) Preterm birth (less than 37 weeks)Preterm birth before 37 weeks appeared to favour management based on knowledge of FFN results (20.7%) compared to controls without such knowledge (29.2%) though the confidence intervals (CIs) just crossed the line of no effect so we could not be certain of this effect (risk ratio (RR) 0.72, 95% CI 0.52 to 1.01; 5 trials; 434 women; low‐quality evidence; Analysis 1.1). Three out of five trials had RRs less than one, with no heterogeneity.We performed a sensitivity analysis for the primary outcome, by removing Nguyen 2002 which was assessed to be at unclear risk of allocation concealment. Removing this data from the analysis indicated that knowledge of FFN may result in fewer preterm births before 37 weeks (19.4% compared to 29.9%) with CI below the line of no effect (RR 0.67, 95% CI 0.46 to 0.97; 4 trials; 357 women; Analysis 2.1).
primary outcome:
Prophylactic oxytocin for the third stage of labour to prevent postpartum haemorrhage
Blood loss 500 mL or more after delivery*Need for additional uterotonics*Maternal all‐cause mortality
primary outcome:
Active versus expectant management for women in the third stage of labour
severe primary PPH, 1000 mL or more at time of birth (average RR 0.31, 95% CI 0.05 to 2.17, 2 studies, 2941 women, random‐effects (Tau² = 1.46, Chi² P = 0.06, I² = 71%) Analysis 2.1);maternal Hb less than 9 g/dL at 24 to 72 hours (RR 0.17, 95% CI 0.02 to 1.47, 1 study, 193 women; Analysis 2.4).neonatal jaundice requiring phototherapy or exchange transfusion (RR 1.31, 95% CI 0.78 to 2.18, 1 study, 1447 infants; Analysis 2.6).admission to neonatal special care or intensive care unit (RR 1.02, 95% CI 0.55 to 1.88, 1 study, 1512 infants; Analysis 2.5).severe primary PPH, blood loss1000 mL or more at time of birth (RR 0.23, 95% CI 0.09 to 0.55, 1 study, 1648 women; Analysis 9.1).severe primary PPH at time of birth of 1000 mL or more (RR 0.78, 95% CI 0.48 to 1.24, 1 study, 1621 women; Analysis 10.1).maternal Hb less than 9 g/dL at 24 to 72 hours (RR 1.23, 95% CI 0.75 to 2.01, 1 study, 1631 women; Analysis 10.4).maternal Hb less than 9 g/dL at 24 to 72 hours (RR 0.80, 95% CI 0.34 to 1.90; Analysis 11.4).
primary outcome:
Uterotonic agents for preventing postpartum haemorrhage: a network meta‐analysis
PPH ≥ 500 mL; andPPH ≥ 1000 mL.
primary outcome:
Care prior to and during subsequent pregnancies following stillbirth for improving outcomes
Stillbirth;Neonatal death;Adverse perinatal outcome (composite outcome including stillbirth, neonatal death, and major neonatal morbidity such as hypoxic‐ischaemic encephalopathy; intracranial haemorrhage; retinopathy of prematurity; necrotising enterocolitis);Adverse maternal psychological effects (anxiety, depression or complicated grief).
primary outcome:
Interventionist versus expectant care for severe pre‐eclampsia between 24 and 34 weeks' gestation
Three studies (415 women) reported on primary outcomes of relevance to the woman. Two studies reported on maternal death, and there were no maternal deaths in either study (0/159 vs 0/161; effect not estimable; two studies, 320 women; low‐quality evidence; Analysis 1.1). Due to very low‐quality evidence from two studies, it was unclear whether interventionist care reduced eclampsia (risk ratio (RR) 0.98, 95% confidence interval (CI) 0.06 to 15.58; two studies, 359 women; Analysis 1.2), or pulmonary oedema (RR 0.45, 95% CI 0.07 to 3.00; two studies, 415 women; Analysis 1.3). Low‐quality evidence from two studies suggested little or no clear difference between the interventionist and expectant care groups for HELLP syndrome (RR 1.09, 95% CI 0.62 to 1.91; two studies, 359 women; Analysis 1.4). Stroke was not an outcome reported in any trial.For the baby, there was insufficient evidence for any reliable conclusions about the effects on stillbirth (RR 0.30, 95% CI 0.07 to 1.23; five trials; 692 women, with 700 babies), perinatal death (RR 1.11, 95% CI 0.62 to 1.99; three studies, 343 infants; low‐quality evidence), or neonatal death after delivery (RR 1.32, 95% CI 0.80 to 2.19; five trials; 485 babies; Analysis 1.6. More babies whose mothers had been allocated to the interventionist group had intraventricular haemorrhage (RR 1.94, 95% CI 1.15 to 3.29; two trials; 537 women; moderate‐quality evidence; Analysis 1.7).
primary outcome:
Methods for blood loss estimation after vaginal birth
Postpartum anaemia (defined as a haemoglobin (Hb) lower than 9 mg/dL)Severe morbidity (including coagulopathy, organ failure, intensive care unit admission, or as defined by authors)
primary outcome:
Discontinuation of intravenous oxytocin in the active phase of induced labour
Caesarean delivery
primary outcome:
Progestogen for treating threatened miscarriage
Miscarriage
primary outcome:
Acute tocolysis for uterine tachysystole or suspected fetal distress
Perinatal death or severe morbidity (at least one neonatal intensive care unit (NICU) admission for 24 hours or more, neonatal encephalopathy or convulsions).Fetal or neonatal mortality.Caesarean delivery.
primary outcome:
Parenteral opioids for maternal pain management in labour
Maternal satisfaction with analgesia measured during labourMaternal satisfaction with analgesia in labour measured during the postnatal period
primary outcome:
Interventions for investigating and identifying the causes of stillbirth
Change in the final cause(s) of death from the presumed or clinical a priori cause of death.Final cause(s) of death unknown.Additional parental counselling or subsequent pregnancy care information (e.g. determination of or change in recurrence risk; exclusion of suspected causes of death; exclusion of recurrent causes of death; or combination of these).Parental satisfaction with the process and outcomes of investigations.
primary outcome:
Antifibrinolytic drugs for treating primary postpartum haemorrhage
Mortality due to bleedingAll‐cause mortality*Serious maternal morbidity (renal or respiratory failure, cardiac arrest or multiple organ failure)
primary outcome:
Planned birth at or near term for improving health outcomes for pregnant women with gestational diabetes and their infants
For this review, we adapted the core outcome set agreed by consensus between review authors of the Cochrane Pregnancy and Childbirth systematic reviews for prevention and treatment of gestational diabetes and pre‐existing diabetes. The core outcome set was adapted to ensure that the outcome measures included were appropriate for this research question.
primary outcome:
Antenatal maternal education for improving postnatal perineal healing for women who have birthed in a hospital setting
An objective measure of wound healing, such as time to complete healing; absolute or percentage change in injured area over time
primary outcome:
Regimens of ultrasound surveillance for twin pregnancies for improving outcomes
The primary outcome was perinatal mortality (after randomisation).
primary outcome:
Antibiotic prophylaxis for episiotomy repair following vaginal birth
Incidence of episiotomy wound infection (including oedema, erythema, serosanguinous, or frankly purulent material), as defined by trial authors.Incidence of episiotomy wound dehiscence (breakdown).Incidence of puerperal infection (e.g. endometritis with or without myometritis, and with or without salpingitis causing maternal febrile morbidity after an episiotomy), as defined by authors.
primary outcome:
Interventions for treating genital Chlamydia trachomatis infection in pregnancy
Microbiological cure ‐ negative Chlamydia test at least three weeks after treatment of the mother
primary outcome:
Interconception care for women with a history of gestational diabetes for improving maternal and infant outcomes
For this update, we used the core outcome set agreed by consensus between review authors of Cochrane Pregnancy and Childbirth systematic reviews for prevention and treatment of gestational diabetes mellitus (GDM) and pre‐existing diabetes, which we adapted, as appropriate for this review question.
primary outcome:
Elective repeat caesarean section versus induction of labour for women with a previous caesarean birth
Death or serious maternal morbidity (as defined by trial authors)Death or serious infant morbidity (as defined by trial authors)
primary outcome:
Perineal techniques during the second stage of labour for reducing perineal trauma
Intact perineumPerineal trauma not requiring suturingPerineal trauma requiring suturingFirst‐degree perineal tearSecond‐degree perineal tearThird‐ and fourth‐degree tearsIncidence of episiotomy
primary outcome:
Fetal and umbilical Doppler ultrasound in high‐risk pregnancies
We selected outcome measures with the help of a proposed core data set of outcome measures (Devane 2007).
primary outcome:
Treating periodontal disease for preventing adverse birth outcomes in pregnant women
Perinatal outcomes:Maternal outcomes:
primary outcome:
Cervical stitch (cerclage) for preventing preterm birth in singleton pregnancy
Perinatal loss: all losses including miscarriages, stillbirth and neonatal deaths.Serious neonatal morbidity (as defined by trialists).Baby discharged home healthy (without obvious pathology ‐ as defined by trialists).
primary outcome:
Patient‐controlled analgesia with remifentanil versus alternative parenteral methods for pain management in labour
Satisfaction with pain relief (as defined by trialists).Adverse events for women:apnoea (≥ 20 s of zero respiratory rate);respiratory depression (less than nine breaths/minute);oxygen desaturation (SpO2 ≤ 95%, ≤ 92%);hypotension;bradycardia;nausea;vomiting;pruritus;postpartum haemorrhage (≥ 1000 mL);sedation at one hour after onset of analgesia.Adverse events for newborns:Apgar score less than seven at five minutes;Apgar score at five minutes;need for naloxone;depressed baby;fetal heart rate (FHR)/cardiotocography (CTG) abnormalities or non‐reassuring fetal status;neonatal neurologic and adaptive capacity score (NACS).
primary outcome:
Pelvimetry for fetal cephalic presentations at or near term for deciding on mode of delivery
Caesarean sectionPerinatal mortality
primary outcome:
Fundal pressure during the second stage of labour
We identified five trials including 3057 women for this comparison (Acmaz 2015; Api 2009; Mahendru 2010; Novikova 2009; Peyman 2011).We included four trials including 891 women for this comparison (Acanfora 2013; Cox 1999; Kang 2009; Kim 2013).
primary outcome:
Bed rest with and without hospitalisation in multiple pregnancy for improving perinatal outcomes
Very preterm birth (less than 34 weeks' gestation)Perinatal mortality (defined by trialists)Low birthweight (less than 2500 g)
primary outcome:
Iodine supplementation for women during the preconception, pregnancy and postpartum period
We included studies which met the above‐mentioned criteria regardless of outcomes reported, though we only extracted the outcomes described below.
primary outcome:
Planned early birth versus expectant management for women with preterm prelabour rupture of membranes prior to 37 weeks' gestation for improving pregnancy outcome
proven neonatal infection with positive blood culture within 48 hours of birth;proven neonatal infection with positive blood culture 48 hours or more after birth.
primary outcome:
Breastfeeding education and support for women with twins or higher order multiples
Initiation of breastfeeding (baby put to the breast, even if on one occasion only McAndrew 2012) or breast milk feeding for each baby.Initiation of breast milk expression by the mother.Stopping any breastfeeding or any breast milk feeding before four to six weeks postpartum for each baby.Stopping exclusive breastfeeding or exclusive breast milk feeding (baby has only ever been given breast milk and never given formula, solid foods or any other liquids McAndrew 2012) before four to six weeks postpartum for each baby.Stopping breast milk expression before four to six weeks postpartum.Stopping any breastfeeding or any breast milk feeding before six months postpartum for each baby.Stopping exclusive breastfeeding or exclusive breast milk feeding before six months postpartum for each baby.Stopping breast milk expression before six months postpartum.
primary outcome:
Psychosocial interventions for supporting women to stop smoking in pregnancy
Smoking abstinence in late pregnancy (point prevalence abstinence):self‐reported or biochemically validated;biochemically validated only.
primary outcome:
Medical treatments for incomplete miscarriage
Complete miscarriage (diagnosis of complete miscarriage based on findings at surgery, or ultrasound examination, or both, after a specific period, or cessation of symptoms and signs, or both).Surgical evacuation.Death or serious complications (e.g. uterine rupture, haemorrhage, sepsis, coagulopathy, uterine perforation, hysterectomy, organ failure, intensive care unit admission).
primary outcome:
Planned early delivery versus expectant management for hypertensive disorders from 34 weeks gestation to term
Composite maternal outcome, including maternal mortality (death during pregnancy or up to 42 days after delivery) and severe morbidity (eclampsia; cerebral vascular event; pulmonary oedema as defined by trial authors; severe renal impairment, defined as a creatinine level greater than 125 μmol/l or a need for dialysis or urine output less than 0.5 mL/kg/hour for four hours unresponsive to hydration with two intravenous boluses, or as defined by trial authors; liver haematoma or rupture; liver failure, defined as the rapid impairment of synthetic function and development of encephalopathy or as defined by trial authors; haemolysis elevated liver enzymes and low platelets (HELLP) syndrome; disseminated intravascular coagulation (DIC); thromboembolic disease; and abruptio placentae, defined as a retroplacental clot of more than 15% of the maternal surface or as defined by trial authors).Composite perinatal outcome, including fetal or neonatal death (within six weeks after the expected due date or as defined by trial authors); grade III or IV intraventricular or intracerebral haemorrhage; necrotising enterocolitis (NEC); acute respiratory distress syndrome (ARDS) or grade III/IV hyaline membrane disease; small‐for‐gestational age (growth below the 10th centile or as defined by trial authors); and neonatal seizures.
primary outcome:
Planned early birth versus expectant management (waiting) for prelabour rupture of membranes at term (37 weeks or more)
Primary outcomes were chosen to be most representative of the clinically important measures of effectiveness and complications. We assessed the primary outcome of maternal infectious morbidity (chorioamnionitis and/or endometritis), and explored its individual components as secondary outcomes. Primary outcomes were as follows.
primary outcome:
Prophylactic versus selective blood transfusion for sickle cell disease in pregnancy
Maternal deathSevere maternal morbidity (e.g. organ failure, pulmonary embolism, fat embolism, stroke, intensive care unit admission; or as defined by trial authors) Perinatal death
primary outcome:
Antenatal breastfeeding education for increasing breastfeeding duration
Duration of any BFDuration of exclusive BFProportion of women with any BF at three and six monthsProportion of women exclusively BF at three and six monthsInitiation of BF
primary outcome:
Nitric oxide donors for cervical ripening and induction of labour
uterine hyperstimulation with FHR changes (RR 0.21, 95% CI 0.01 to 4.22; two trials, 508 women, (Analysis 7.2);caesarean section (RR 0.97, 95% CI 0.78 to 1.21; three trials, 571 women, Analysis 7.4).unfavourable cervix (Analysis 8.1; Analysis 8.2);intact membranes and unfavourable cervix (Analysis 9.1; Analysis 9.2);primiparae (Analysis 10.2; Analysis 10.3);all primiparae and unfavourable cervix (Analysis 11.1; Analysis 11.2);all primiparae, intact membranes, unfavourable cervix (Analysis 12.1; Analysis 12.2).
primary outcome:
Interventions for promoting the initiation of breastfeeding
Initiation of breastfeeding.Early initiation of breastfeeding (within one hour after birth).
primary outcome:
Chewing gum for enhancing early recovery of bowel function after caesarean section
Time to the first passage of flatus, in hoursProportion of women with ileus as defined by the study authors or symptoms and signs of gastrointestinal disturbance such as nausea, vomiting, abdominal cramping or abdominal distension, within the first 72 hours after CSTolerance to gum and adverse effects of gum chewing (such as jaw pain), within the first 72 hours after CS
primary outcome:
Effect of restricted pacifier use in breastfeeding term infants for increasing duration of breastfeeding
Prevalence or proportion of infants being fully or partially breastfed at three, four and six months of age.Duration of full or exclusive breastfeeding (months) as defined by Labbok 1990.Duration of any or partial breastfeeding (months).
primary outcome:
Rooming‐in for new mother and infant versus separate care for increasing the duration of breastfeeding
Duration of exclusive breastfeeding.Duration of any breastfeeding.Proportion of infants being exclusively breastfed at six months of age.Proportion of infants being given any breastfeeding at six months of age (not pre‐specified).Exclusive breastfeeding is defined as an infant receiving only breast milk, without any additional food or supplement.Any breastfeeding is defined as an infant receiving any amount of breast milk, regardless of supplements.
primary outcome:
Amnioinfusion for chorioamnionitis
Only one trial was included (with data from a total of 34 participants). There was no clear difference in the incidence of postpartum endometritis between the group of women who received amnioinfusion and those who did not (risk ratio (RR) 1.50, 95% confidence interval (CI) 0.29 to 7.87; absolute risk 176/1000 (95% CI 34 to 96) versus 118/1000; low‐quality evidence (Analysis 1.1)). Similarly, there was no clear difference in neonatal infection between groups (RR 3.00, 95% CI 0.13 to 68.84; absolute risk 0/1000 (95% CI 0 to 0) versus 0/1000; low‐quality evidence (Analysis 1.2)). The outcome perinatal death or severe morbidity was not reported.
primary outcome:
Dopamine agonists for preventing future miscarriage in women with idiopathic hyperprolactinemia and recurrent miscarriage history
Rate of miscarriage (before 20 weeks of gestation).Rate of live birth (term delivery or premature delivery rate).
primary outcome:
Immediate versus deferred delivery of the preterm baby with suspected fetal compromise for improving outcomes
Extended perinatal mortality (intrauterine death or death in the first 28 days of life).Serious neonatal morbidity (composite outcome including bronchopulmonary dysplasia (BPD), necrotising enterocolitis (NEC), intraventricular haemorrhage (IVH), retinopathy of prematurity (ROP), hypoxic Ischaemic encephalopathy (HIE).Death or disability at or after two years of age.
primary outcome:
Sealing procedures for preterm prelabour rupture of membranes
Infant ‐ perinatal mortality (intrauterine fetal demise and neonatal death). (Intrauterine fetal demise defined as fetal death after 20 weeks’ gestation and prior to delivery; neonatal death defined as death within the first 28 days of life.)
primary outcome:
Interventions for treating hyperemesis gravidarum
For the sake of comparison, some outcome measures for this review align with the outcome measures used in the previous Cochrane review on interventions for nausea and vomiting in early pregnancy (Matthews 2015). The time frame for follow‐up of outcome measures, including maternal and neonatal safety data, was defined by individual trials. The outcomes below are slightly different from what was initially published in the protocol for this review. Severity of nausea/vomiting was added as a primary outcome because it was found that this was often what was reported in the included studies. Similarly, rather than reporting the number of women requiring additional antiemetics, the outcome "number of antiemetics required" was used instead as this was more often reported.
primary outcome:
Oxytocin for preventing postpartum haemorrhage (PPH) in non‐facility birth settings
Severe PPH (blood loss greater than or equal to 1000 mL, or as defined by authors).Severe maternal morbidity (hysterectomy, intensive care admission, massive blood products transfusion, organ failure, or as defined by authors).Maternal deaths.
primary outcome:
Techniques for assisting difficult delivery at caesarean section
Infant birth trauma (any of: subdural or intracerebral haemorrhage, spinal cord injury, basal skull fracture, other fracture, peripheral nerve injury).Infant birth trauma was not reported in the David 1998 trial.Of the fetal outcomes assessed, Fasubaa 2002, Bastani 2012 and Veisi 2012 reported infant birth trauma; with no difference between the two interventions (three studies; 239 women; RR 1.55, 95% confidence interval (CI) 0.42 to 5.73), Analysis 2.1.Bofill 2000 reported birth trauma as an outcome but there were no instances of birth trauma in either comparison group, Analysis 3.1.
primary outcome:
Breastfeeding or nipple stimulation for reducing postpartum haemorrhage in the third stage of labour
Severe PPH (measured or estimated blood loss of 1000 mL or more, or as defined by the trial authors)Maternal death or severe morbidity (including major surgery, organ failure, hyperpyrexia, intensive care unit admission, hysterectomy, compression sutures, artery ligations, or as defined by trial authors), reported together or separately
primary outcome:
Planned caesarean section for women with a twin pregnancy
Perinatal or neonatal death (excluding fatal anomalies) or serious neonatal morbidity (e.g. severe birth asphyxia, seizures, neonatal encephalopathy, serious birth trauma, severe respiratory distress syndrome (RDS), prolonged neonatal intensive care unit admission; or as defined by trial authors).Perinatal or infant death (excluding fatal anomalies) or disability in childhood.Maternal death or serious maternal morbidity (e.g. admission to intensive care unit, septicaemia, organ failure, uterine rupture, hysterectomy, major surgical complication, life‐threatening event, long‐term disability, or as defined by trial authors).
primary outcome:
Incentives for increasing prenatal care use by women in order to improve maternal and neonatal outcomes
Preterm birth < 37 weeks.Small‐for‐gestational age.Perinatal deaths (fetal, neonatal, infant deaths).
primary outcome:
Different treatment regimens of magnesium sulphate for tocolysis in women in preterm labour
Clinically relevant outcomes for trials of tocolysis for inhibiting preterm labour have been pre‐specified following consultation with the editors and authors of the individual reviews.Consensus was reached on a set of six ‘core’ outcomes, which are highlighted below. These have been included in all tocolysis reviews. In addition to these core outcomes, individual teams may include other outcomes as necessary.
primary outcome:
Prophylactic oral betamimetics for reducing preterm birth in women with a twin pregnancy
Spontaneous onset preterm labourPreterm prelabour rupture of membranesPreterm birth
primary outcome:
Health system and community level interventions for improving antenatal care coverage and health outcomes
Coverage of ANC: the proportion of pregnant women who attend at least four ANC visits during pregnancy.Pregnancy‐related deaths: the proportion of women who die during pregnancy or 42 days after, irrespective of cause (WHO 2004).
primary outcome:
Use of biochemical tests of placental function for improving pregnancy outcome
Death of a baby (stillbirth or neonatal death)Small‐for‐gestational age (below 10th centile on customised birthweight chart, or as defined by trialists)
primary outcome:
Nutritional advice for improving outcomes in multiple pregnancies
Early preterm births (before 34 weeks)Small‐for‐gestational age (SGA) at birth (as defined by the trialists)
primary outcome:
Nitroglycerin for management of retained placenta
Manual removal of the placenta.Maternal mortality.Severe postpartum haemorrhage (S‐PPH) (defined as clinically estimated or measured blood loss greater than or equal to 1000 mL) (not pre‐specified).Blood transfusion.Addition of therapeutic uterotonics (not pre‐specified).
primary outcome:
Specialised antenatal clinics for women with a multiple pregnancy for improving maternal and infant outcomes
Perinatal death (defined as stillbirth of one or more infants after trial entry, or death of one or more liveborn infants up to 28 days of age).Small‐for‐gestational age (defined as birthweight less than the 10th centile for gestational age).Very preterm birth (defined as birth less than 34 weeks' gestation).Maternal death.
primary outcome:
Ethanol for preventing preterm birth in threatened preterm labor
The Cochrane Pregnancy and Childbirth Group's (PCG) Consensus statement, "Adopting a consistent approach to PCG systematic reviews on tocolysis for inhibiting preterm labour" was followed in development of these outcomes. We include the core outcomes in the consensus statement below. These core outcomes are denoted by an asterisk.Compared to other tocolytic drugs (all involved a comparison of ethanol to betamimetics), ethanol treatment was associated with no clear difference in births < 48 hours after trial entry (three trials, 192 women; average RR 1.12, 95% CI 0.53 to 2.37, Tau² = 0.19; I² = 59% Analysis 2.1,) or perinatal mortality (six trials, 698 women; RR 1.20, 95% CI 0.78 to 1.84, Analysis 2.2), but higher rates of neonatal mortality (eight trials, 1238 women; RR 1.43, 95% CI 1.02 to 2.02, Analysis 2.3)). Serious maternal adverse events were not reported
primary outcome:
Reduction of the number of fetuses for women with a multiple pregnancy
Early pregnancy loss (less than 20 weeks' gestation) (loss as a direct result of the reduction technique will be a subcategory).Stillbirth (death greater than 20 weeks' gestation and before birth).Very preterm birth (less than 34 weeks' gestation).Birthweight (less than 1500 g).Need for admission to the neonatal intensive care unit.Neonatal death and serious infant morbidity (defined as growth restriction; seizures; birth asphyxia defined by trialists; neonatal encephalopathy; disability in childhood).Maternal death and serious maternal morbidity (e.g. admission to intensive care unit, infection requiring intravenous antibiotics, haemorrhage requiring blood transfusion).No surviving child.
primary outcome:
Risk‐scoring systems for predicting preterm birth with the aim of reducing associated adverse outcomes
Delivery at less than 32 completed weeks (high‐risk group) ‐ definition of this very preterm group may differ between studies with respect to gestational cut‐off and we will abide by the author's definition of very preterm birth; we selected 32 weeks as the cut‐off because we refer locally to very preterm birth as birth before 32 completed weeks' gestation.Delivery at less than 37 completed weeks (and not included in high‐risk group) (low‐risk group).Death (we plan to report stillbirth, neonatal mortality, and infant mortality separately).
primary outcome:
Intermittent oral iron supplementation during pregnancy
Maternal, perinatal and postpartum clinical and laboratory outcomes and infant clinical and laboratory outcomes as described below.
primary outcome:
Fetal movement counting for assessment of fetal wellbeing
Perinatal death or severe morbidity (neonatal intensive care unit admission, neonatal encephalopathy)Caesarean section
primary outcome:
Antenatal cardiotocography for fetal assessment
Perinatal mortalityCaesarean section
primary outcome:
Symphysial fundal height (SFH) measurement in pregnancy for detecting abnormal fetal growth
Neonatal detection of small‐for‐dates (variously defined by authors).Neonatal detection of large‐for‐gestational age (variously defined by authors).Perinatal mortality (variously defined by authors).
primary outcome:
Anti‐D administration in pregnancy for preventing Rhesus alloimmunisation
Incidence of Rhesus D alloimmunisation (during pregnancy, postpartum, and in subsequent pregnancies)
primary outcome:
Treatments for breast abscesses in breastfeeding women
Time to complete resolution of breast abscess (resolution of abscess was defined as no recurrence of abscess or need for any intervention). Time was defined by the authors as time of presentation for care or from time of hospitalisation.Any continuation of breastfeeding after treatment (success).Treatment failure.
primary outcome:
High feedback versus low feedback of prenatal ultrasound for reducing maternal anxiety and improving maternal health behaviour in pregnancy
Maternal anxiety measured by State Trait Anxiety Inventory as defined by the investigators of each included study.
primary outcome:
Education for contraceptive use by women after childbirth
To be included, trials had to have data on unplanned pregnancies or contraceptive choice or use. The trials may have had other primary outcomes.
primary outcome:
Expedited versus conservative approaches for vaginal delivery in breech presentation
Death or serious neonatal morbidity (significant trauma, encephalopathy, intracranial haemorrhage, intensive care unit (ICU) admission > 24 hours, or as defined by trial authors).
primary outcome:
Planned caesarean section for term breech delivery
Perinatal or neonatal death (excluding fatal anomalies) or serious neonatal morbidity (e.g. seizures, birth asphyxia as defined by trial authors, neonatal encephalopathy, birth trauma);perinatal, neonatal or infant death (excluding fatal anomalies) or disability in childhood;maternal death or serious maternal morbidity (e.g. admission to intensive care unit, septicaemia, organ failure).
primary outcome:
Ultrasound for fetal assessment in early pregnancy
Detection of major fetal abnormality (as defined by the trial authors) prior to 24 weeks' gestation.Detection of multiple pregnancy by 24 weeks' gestation.Induction of labour for 'post‐term' pregnancy.Perinatal death (defined as stillbirth after trial entry, or death of a liveborn infant up to 28 days of age).
primary outcome:
Routine ultrasound in late pregnancy (after 24 weeks' gestation)
Induction of labour.Caesarean section.Perinatal mortality.Preterm delivery less than 34 weeks.Preterm delivery less than 37 weeks (non‐prespecified).Neurodevelopment at age two.Maternal psychological effects.
primary outcome:
Tranexamic acid for preventing postpartum haemorrhage
1. Blood loss 500 mL or more
2. Blood loss 1000 mL or more
primary outcome:
Diet or exercise, or both, for preventing excessive weight gain in pregnancy
Excessive weight gain as defined by investigators.
primary outcome:
Effects of restricted caffeine intake by mother on fetal, neonatal and pregnancy outcomes
The mean birthweight for babies born to women in the caffeinated group was 3539 g (standard deviation (SD) 604 g), compared with 3519 g (SD 607 g) for babies born to women in the decaffeinated group (P = 0.48). There was no significant difference between the two groups (mean difference (MD) 20.00, 95% confidence interval (CI) ‐48.68 to 88.68; participants = 1197) (Analysis 1.1). In the caffeinated and decaffeinated groups, respectively, 4.5% (25/552) and 4.7% (28/598) of infants were born small‐for‐gestational age (risk ratio (RR) 0.97, 95% CI 0.57 to 1.64; participants = 1150) (Analysis 1.3). This difference was not statistically significant.In the caffeinated and decaffeinated groups, respectively, 4.2% (23/552) and 5.2% (3.1/601) of infants were born preterm (RR 0.81, 95% CI 0.48 to 1.37; participants = 1153) (Analysis 1.2). This comparison was not found to be statistically significant.The authors concluded that drinking three cups of coffee per day did not have any effect on birthweight or gestational age. However, they could not rule out that larger reductions in caffeine might increase birthweight.The only outcomes reported in the trial of interest (Bech 2007) in this review were birthweight, preterm birth and small‐for‐gestational age. As the analysis suggests, a modest reduction in intake during the second and third trimester, by providing decaffeinated coffee to women who drank three or more cups/day early in pregnancy, did not affect birthweight or length of gestation. None of the other prespecified outcomes were included in this trial.
primary outcome:
Planned early delivery versus expectant management for monoamniotic twins
Perinatal death or serious neonatal morbidity (e.g. severe birth asphyxia, seizures, neonatal encephalopathy, serious birth trauma, severe respiratory distress syndrome, prolonged neonatal intensive care unit admission; or as defined by trial authors).
primary outcome:
Fetal and umbilical Doppler ultrasound in normal pregnancy
Perinatal death (stillbirths and neonatal deaths including anomalies)Serious neonatal morbidity ‐ composite outcome including hypoxic ischaemic encephalopathy, intraventricular haemorrhage, bronchopulmonary dysplasia, necrotising enterocolitis
primary outcome:
External cephalic version for breech presentation at term
Vaginal cephalic birth not achieved (not prespecified)Caesarean section
primary outcome:
Bed rest in singleton pregnancies for preventing preterm birth
Preterm birth (less than 37 weeks)Perinatal mortalityLow birthweight (less than 2500 g)Neonatal intensive care
primary outcome:
Oral analgesia for relieving post‐caesarean pain
Adequate pain relief as reported by the woman, or by determination of more than 50% relief of pain (as either stated by the woman or calculated using a formula)*.Need for additional pain relief with a different drug.
primary outcome:
Community‐based intervention packages for reducing maternal and neonatal morbidity and mortality and improving neonatal outcomes
Maternal mortality was defined as the number of maternal deaths per live births. Maternal death is defined as the death of a woman while pregnant or within 42 days of termination of pregnancy, irrespective of the duration and delivery site of the pregnancy, from any cause related to or aggravated by the pregnancy or its management.Neonatal mortality was defined as the number of neonatal deaths from any cause among total live births:
primary outcome:
Combined hormonal versus nonhormonal versus progestin‐only contraception in lactation
Quantity of milkBiochemical analysis of milk compositionInitiation, maintenance and duration of lactation (any or fully breastfeeding)Infant growthTiming of contraception initiation and its effects on lactation
primary outcome:
Interventions for helping to turn term breech babies to head first presentation when using external cephalic version
Cephalic presentation at labour and at birth.Failure to achieve cephalic vaginal birth (composite outcome: caesarean section plus vaginal breech birth)*.Caesarean section.Fetal bradycardia or prolonged decelerations as defined by trial authors.
primary outcome:
Group versus conventional antenatal care for women
Gestational age at birth (preterm birth defined as birth before 37 completed gestational weeks; very preterm birth defined as birth before 34 completed gestational weeks).Low birthweight (defined as less than 2500 g).Small‐for‐gestational age (defined as less than the 10th percentile for gestation and gender).Perinatal mortality.
primary outcome:
Antibiotic regimens for postpartum endometritis
Treatment failure (as defined by the individual trials);severe complications (including pelvic abscess and septic pelvic vein thrombophlebitis);maternal death.
primary outcome:
Controlled cord traction for the third stage of labour
 Blood loss of 1000 mL or more after birth    Manual removal of the placenta
primary outcome:
Prophylactic manual rotation for fetal malposition to reduce operative delivery
Operative delivery (forceps or vacuum delivery or caesarean section).Maternal mortality.Perinatal mortality (stillbirth and neonatal death).
primary outcome:
Routine perineal shaving on admission in labour
Postpartum maternal febrile morbidity: clinical signs or symptoms (persistent temperature of at least 37.5 degrees centigrade, tachycardia), and an elevated white blood cell count (at least 20,000/mm³).Wound infection: persistent temperature of at least 37.5 degrees centigrade with clinical symptoms such as localised erythema and/or discharge and/or a positive wound swab culture with an organism likely to cause infection.Neonatal infection: if the baby had one or more of the following: probable sepsis; probable meningitis; or probable pneumonia. This will be considered present if the baby has clinical signs/symptoms (respiratory distress, irritability, temperature instability, feeding difficulties, early onset jaundice, poor perfusion, hypotension, apnoea, seizures, tachycardia, lethargy), and either an abnormal sepsis screen or abnormal cerebrospinal fluid finding.
primary outcome:
Interventions for preventing or reducing domestic violence against pregnant women
Reduction of episodes of violence (physical, sexual, and/or psychological)Prevention of violence during and up to one year after pregnancy as defined by the authors of trials
primary outcome:
Antibiotics for prelabour rupture of membranes at or near term
probable early‐onset neonatal sepsis;definite early‐onset neonatal sepsis;maternal infectious morbidity (chorioamnionitis and/or endometritis);stillbirth;perinatal mortality;neonatal mortality;serious maternal outcome (defined as death, cardiac arrest, respiratory arrest, anaphylaxis, admission to intensive care unit).
primary outcome:
Early versus late initiation of epidural analgesia for labour
Incidence of caesarean section (dichotomous)Incidence of instrumental birth (dichotomous)Duration of first stage of labour from randomisation (continuous)Duration of second stage of labour (continuous)
primary outcome:
High‐dose versus low‐dose oxytocin infusion regimens for induction of labour at term
Vaginal delivery not achieved within 24 hours (or period specified by trial authors).Uterine hyperstimulation with fetal heart rate (FHR) changes.Caesarean section.Serious neonatal morbidity or perinatal death (e.g. seizures, birth asphyxia defined by trialists, neonatal encephalopathy, disability in childhood).Serious maternal morbidity or death (e.g. uterine rupture, admission to intensive care unit, septicaemia).
primary outcome:
Antibiotic prophylaxis for third‐ and fourth‐degree perineal tear during vaginal birth
Fever or puerperal febrile morbidity (body temperature of 38ºC or higher occurring on any two occasions in the first 10 days postpartum, exclusion of the first 24 hours).Perineal wound complications, including infection (oedematous, erythematous, wound edge with pain, serosanguinous or frankly purulent material), or wound dehiscence (wound separation).
primary outcome:
Fetal pulse oximetry for fetal assessment in labour
(1) Caesarean section
(2) Hypoxic‐ischaemic encephalopathy
(3) Neonatal seizures
(4) Long‐term neurodevelopmental outcome
primary outcome:
Fetal assessment methods for improving neonatal and maternal outcomes in preterm prelabour rupture of membranes
Fetal death (antenatal). This was clarified from the original outcome of "any fetal death" in the review protocol.Neonatal death (in the first 28 days of life). This was clarified from the original outcome of "any fetal death" in the review protocol. Neonatal death was included in the protocol as a secondary outcome.Maternal death.Serious maternal morbidity defined as: 1) septicaemia, 2) need for intensive care, 3) organ failure/need for ventilation, 4) need for hysterectomy.
primary outcome:
Cervical stitch (cerclage) for preventing preterm birth in multiple pregnancy
Perinatal deathsSerious neonatal morbidity (defined by trialists)Perinatal deaths and serious neonatal morbidity
primary outcome:
Magnesium sulphate for preventing preterm birth in threatened preterm labour
Birth less than 48 hours after trial entry.Extremely preterm birth (less than 28 weeks' gestation).Serious infant outcome (defined as death or chronic lung disease [need for supplemental oxygen at 28 days of life or later], grade three or four intraventricular haemorrhage or periventricular leukomalacia, major neurosensory disability (defined as any of legal blindness, sensorineural deafness requiring hearing aids, moderate or severe cerebral palsy, or developmental delay/intellectual impairment [defined as developmental quotient (DQ) or intelligence quotient (IQ) less than two standard deviations below mean])).Serious maternal outcome (defined as death, cardiac arrest, respiratory arrest, admission to intensive care unit).
primary outcome:
Surgical techniques for uterine incision and uterine closure at the time of caesarean section
Postoperative febrile morbidity (as defined by trial authors).
primary outcome:
Combination of tocolytic agents for inhibiting preterm labour
Serious maternal outcomes (see definition below).Short‐term and long‐term serious infant outcome (see definition below).Birth before 48 hours of trial entry.Preterm neonate delivered without full course of antenatal steroids (see definition below) completed at least 24 hours before birth.Perinatal death after trial entry (see definition below).Birth before 34 completed weeks.Adverse drug reactions (including discontinuation of therapy because of adverse effects).
primary outcome:
Aspirin and/or heparin for women with unexplained recurrent miscarriage with or without inherited thrombophilia
Live birth.
primary outcome:
Oral misoprostol for induction of labour
We chose five primary outcomes as being most representative of the clinically important measures of ineffectiveness and complications:
(1) vaginal delivery not achieved within 24 hours (includes all caesarean sections);
(2) uterine hyperstimulation with fetal heart rate (FHR) changes;
(3) caesarean section;
(4) serious neonatal morbidity or perinatal death (e.g. seizures, birth asphyxia defined by trialists, neonatal encephalopathy, disability in childhood);
(5) serious maternal morbidity or death (e.g. uterine rupture, admission to intensive care unit, septicaemia).Perinatal and maternal morbidity and mortality are composite outcomes. This is not an ideal solution because some components are clearly less severe than others. It is possible for one intervention to cause more deaths but fewer babies with severe morbidity. However, in the context of labour induction at term this is unlikely. All these events will be rare, and a modest change in their incidence will be easier to detect if composite outcomes are presented. We will explore the incidence of individual components as secondary outcomes.
primary outcome:
Extra fluids for breastfeeding mothers for increasing milk production
Satisfactory weight gain in the infant as defined by the trialistsDuration of exclusive breastfeeding (months)Breast milk production as defined by trialists