Prenatal administration of progesterone for preventing preterm birth in women considered to be at risk of preterm birth.
Topic: Hormone Therapy

Preterm birth is a major complication of pregnancy associated with perinatal mortality and morbidity. Progesterone for the prevention of preterm labour has been advocated.

PICO
Population: Women considered to be at risk of preterm birth
Intervention: Prenatal administration of progesterone
Comparison: No progesterone or placebo
Outcomes: Preventing preterm birth in women at risk, reducing perinatal mortality and morbidity

Included studies:
title: Neonatal outcomes in twin pregnancies delivered moderately preterm, late preterm, and term.
abstract: We compared neonatal outcomes in twin pregnancies following moderately preterm birth (MPTB), late preterm birth (LPTB), and term birth. A secondary analysis of a multicenter, randomized controlled trial of multiple gestations was conducted. MPTB was defined as delivery between 32 (0)/(7) and 33 (6)/(7) weeks and LPTB between 34 (0)/(7) and 36 (6)/(7) weeks. Primary outcome was a neonatal outcome composite consisting of one or more of the following: neonatal death, respiratory distress syndrome, early onset culture-proven sepsis, stage 2 or 3 necrotizing enterocolitis, bronchopulmonary dysplasia, grade 3 or 4 intraventricular hemorrhage, periventricular leukomalacia, pneumonia, or severe retinopathy of prematurity. Among 552 twin pregnancies, the MPTB rate was 14.5%, LPTB 49.8%, and term birth rate 35.7%. The rate of the primary outcome was different between groups: 30.0% for MPTB, 12.8% for LPTB, 0.5% for term birth ( P < 0.001). Compared with term neonates, the primary neonatal outcome composite was increased following MPTB (relative risk [RR] 58.5; 95% confidence interval [CI] 11.3 to 1693.0) and LPTB (RR 24.9; 95% CI 4.8 to 732.2). Twin pregnancies born moderately and late preterm encounter higher rates of neonatal morbidities compared with twins born at term.
title: Effect of progesterone on cervical shortening in women at risk for preterm birth: secondary analysis from a multinational, randomized, double-blind, placebo-controlled trial.
abstract: To determine whether progesterone supplementation alters cervical shortening in women at increased risk for preterm birth.
title: A randomised trial of progesterone prophylaxis after midtrimester amniocentesis.
abstract: Midtrimester amniocentesis to investigate fetal karyotype carries a small risk of fetal loss.
title: Estimated effect of 17 alpha-hydroxyprogesterone caproate on preterm birth in the United States.
abstract: A multicenter, randomized placebo-controlled trial among women with singleton pregnancies and a history of spontaneous preterm birth found that weekly injections of 17 alpha-hydroxyprogesterone caproate (17P), initiated between 16 and 20 weeks of gestation, reduced preterm birth by 33%. The current study estimated both preterm birth recurrence and the potential reduction in the national preterm birth rate.
title: Dose-toxicity relationship of carboplatin in combination with cyclophosphamide in ovarian cancer patients.
abstract: A study was undertaken to examine the relationships between carboplatin's pharmacokinetic parameters and the myelotoxicity associated with its administration in combination with cyclophosphamide. An additional aim of the study was to test the applicability of the method proposed by Calvert et al. for calculation of the carboplatin dose to be used in the combination regimen. A total of 24 previously untreated ovarian cancer patients were given a combination of 250-500 mg/m2 carboplatin and 500 mg/m2 cyclophosphamide every 4 weeks for 4 months. The pharmacokinetics of carboplatin and the associated myelotoxicity were investigated in 64 courses. The results showed a significant correlation (r = 0.89) between the AUC calculated for carboplatin and that predicted according to Calvert's formula [carboplatin dose in milligrams = AUC (glomerular filtration rate +25)]. We conclude that the model is a useful guide in the calculation of the carboplatin dose to be given in combination with cyclophosphamide, and it enables a more precise prediction of the carboplatin exposure than does the conventional calculation, which is based on milligrams of drug per square meter of body surface. The AUC for carboplatin was a reliable predictor of the myelotoxicity as measured by the relative decrease in thrombocyte count. However, the relationship between AUC and myelotoxicity changed during the treatment because of increasing bone marrow toxicity. Despite this finding, dose calculation based on carboplatin's AUC appears to provide an improvement in the clinical use of the drug, and the method also seems to be fully applicable in combination chemotherapy with cyclophosphamide.
title: Second trimester cervical length and risk of preterm birth in women with twin gestations treated with 17-α hydroxyprogesterone caproate.
abstract: To compare rates of preterm birth before 35 weeks based on cervical length measurement at 16-20 weeks in women with twin gestations who received 17-α hydroxyprogesterone caproate (17OHPC) or placebo.
title: Survival and cerebral palsy in low birthweight infants: implications for perinatal care.
abstract: Whilst only about a third of all cerebral palsy occurs in children who had been of low birthweight, recent increases in the survival of low and very low birthweight infants have coincided with significant increases in the numbers of cerebral palsy children amongst them. This paper analyses data from the Western Australian Cerebral Palsy Register and from the Maternal and Child Health Research Data Base for stillbirths, neonatal deaths and survivors to address the issues of increased survival, cerebral palsy and timing of brain damage. The analysis is inconclusive but suggestive that both antenatal and postnatal complications are important in the increases in cerebral palsy in low birthweight infants. The good news is that this means that a certain proportion of postnatally damaged low birthweight survivors could possibly be prevented by better neonatal care. The bad news is that the remaining proportion have probably received their damage well before delivery and the possibilities for prevention are still remote. Further studies of low birthweight infants with cerebral palsy are urgently required. They should include antenatal factors, investigating the various aetiological pathways to preterm birth, randomised controlled trials of neonatal interventions and searching for better neonatal predictors of brain damage.
title: The use of vaginal natural progesterone for prevention of preterm birth in IVF/ICSI pregnancies.
abstract: The aim of this study was to evaluate the effect of vaginal natural progesterone on the prevention of preterm birth in IVF/intracytoplasmic sperm injection (ICSI) pregnancies. A single-centre prospective placebo-controlled randomized study was performed. A total of 313 IVF/ICSI pregnant patients were randomized into two groups for either treatment with daily 400 mg vaginal natural progesterone or placebo, starting from mid-trimester up to 37 weeks or delivery. Amongst the patients, there were 215 singleton and 91 twin pregnancies. There was no significant difference in risk of preterm birth among all patients (OR 0.672, 95% CI 0.42-1.0. There was a significantly lower preterm birth rate in singleton pregnancies in the natural progesterone arm (OR 0.53, 95% CI 0.28-0.97) and no significant difference between both arms in twin pregnancies (OR 0.735, 95% CI 0.36-2). In conclusion, the administration of 400 mg vaginal natural progesterone from mid trimester reduced the incidence of preterm birth in singleton, but not in twin, IVF/ICSI pregnancies.
title: Seasonal variations of serum lipids and apoproteins.
abstract: Seasonal variations of blood lipids, which must be considered when performing long-term studies, could be partially due to dietary changes. In the present study, serum lipid parameters were measured each month for 1 year in nuns living in a monastery, whose diet was perfectly regular and controlled. The serum lipid variations observed consisted mainly of an increase in total cholesterol, low-density lipoproteins and apolipoprotein B in autumn and spring and an increase in high-density lipoprotein cholesterol in winter, whereas apolipoproteins A-I and A-II showed a marked increase in summer and at the beginning of autumn. These variations were probably induced by factors directly related to seasonal rhythm and not to dietary factors or physical exercise. Lastly, the influence of sex hormones seems to be very minor, as postmenopausal women (one-third of the persons) had an identical variation in their lipid parameters, to that observed in the whole group.
title: The effect of 17 alpha-hydroxyprogesterone caproate on pregnancy outcome in an active-duty military population.
abstract: A prior report suggested that active-duty pregnant women are at increased risk for low-birth weight infants and a higher perinatal mortality rate. The present double-blind investigation was designed to prospectively evaluate that risk and to test the efficacy of 17 alpha-hydroxyprogesterone caproate to prevent reported complications. Three groups of active-duty women were studied, beginning between 16 and 20 weeks' gestation. They were similar for parity, previous abortion, race, cigarette smoking, and marital status. Of these, 80 were given 17 alpha-hydroxyprogesterone caproate, 88 received placebo, and 78 declined to participate in the protocol. There was no significant differences in the three groups when comparisons were made for low-birth weight infants and for perinatal mortality. However, when comparison was made to a military dependent population, they had a significantly worse outcome with regard to both perinatal mortality (p = 0.001) and infants with a birth weight less than 2,500 gm (p = 0.01). We concluded that pregnant military personnel were at increased risk for adverse pregnancy outcome, but that this risk was not altered by therapy with 17 alpha-hydroxyprogesterone caproate.
title: Study of progesterone for the prevention of preterm birth in twins (STOPPIT): findings from a trial-based cost-effectiveness analysis.
abstract: Preterm birth contributes to a range of healthcare problems amongst infants surmounting to sizeable healthcare costs. Twin pregnancies are at particular risk of preterm birth. The objective of this study was to assess the cost-effectiveness of vaginal progesterone gel for the prevention of preterm birth in twin pregnancies.
title: [Isolated sphenoidal tumor localization in a child, disclosing histiocytosis X].
abstract: A case of isolated sphenoidal tumor localization in a child without any endocrinological disorder and revealing an histiocytosis X is reported. This mode of presentation is extremely rare. The diagnosis of histiocytosis X must be evoked and proved in lesions of the sellar region in children.
title: Bone marrow transplantation in the treatment of patients with lymphoma.
title: Failure of 17-hydroxyprogesterone to reduce neonatal morbidity or prolong triplet pregnancy: a double-blind, randomized clinical trial.
abstract: To test whether 17 alpha-hydroxyprogesterone caproate (17P) will reduce neonatal morbidity by increasing gestational age at delivery in triplet pregnancies.
title: Cervical length changes during preterm cervical ripening: effects of 17-alpha-hydroxyprogesterone caproate.
abstract: The purpose of this study was to evaluate whether 17-alpha-hydroxyprogesterone caproate (17P) treatment affect changes in cervical length.
title: Progesterone and the risk of preterm birth among women with a short cervix.
abstract: Previous randomized trials have shown that progesterone administration in women who previously delivered prematurely reduces the risk of recurrent premature delivery. Asymptomatic women found at midgestation to have a short cervix are at greatly increased risk for spontaneous early preterm delivery, and it is unknown whether progesterone reduces this risk in such women.
title: Prophylactic administration of progesterone by vaginal suppository to reduce the incidence of spontaneous preterm birth in women at increased risk: a randomized placebo-controlled double-blind study.
abstract: The purpose of this study was to evaluate the effect of prophylactic vaginal progesterone in decreasing preterm birth rate in a high-risk population.
title: Vaginal progesterone is associated with a decrease in risk for early preterm birth and improved neonatal outcome in women with a short cervix: a secondary analysis from a randomized, double-blind, placebo-controlled trial.
abstract: To investigate the efficacy of vaginal progesterone to prevent early preterm birth in women with sonographic evidence of a short cervical length in the midtrimester.
title: Exercise-induced changes in populations of peripheral blood mononuclear cells.
abstract: The effects of maximal treadmill exercise on changes in the expression and distribution of peripheral blood B-lymphocytes, T-lymphocytes, and natural killer cells (NK) were examined in 20 healthy men with a mean age of 32.0 +/- 1.3 yr. The percentage and absolute number of peripheral blood mononuclear cells that reacted with specific monoclonal antibodies which bind to B-cells (anti-Leu-12 and anti-human-immunoglobulin D-delta chain-specific), T-cells (OKT3), and NK cells (anti-Leu-11 and anti-Leu-7) were enumerated by a fluorescence-activated cell sorter in samples obtained before (Pre), immediately after (Post), and 1 h after a bout of exercise to exhaustion. In contrast to earlier studies, the results of this study indicate that maximal exertion effects a decrease in the percentage, but no change in the absolute number of peripheral blood B-cells (Pre: 0.21 +/- 0.01; Post: 0.31 +/- 0.02 cells x 10(-6).ml-1). In addition, a small, transient increase in the number of peripheral blood cells reacting with surface markers associated with T-lymphocytes (Pre: 1.15 +/- 0.09; Post: 2.05 +/- 0.19 cells x 10(-6).ml-1) and a striking, transient increase in lymphocytes having NK phenotype activity (Pre: 0.34 +/- 0.03; Post: 1.51 +/- 0.19 cells x 10(-6).ml-1) were noted. All of the pre-exercise values were re-established 1 h after exercise. Whether the mobilization of cells with surface markers associated with NK activity in response to maximal exertion serves any physiologic function during periods of physical stress remains to be determined.
title: Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate.
abstract: Women who have had a spontaneous preterm delivery are at greatly increased risk for preterm delivery in subsequent pregnancies. The results of several small trials have suggested that 17 alpha-hydroxyprogesterone caproate (17P) may reduce the risk of preterm delivery.
title: How should randomised trials including multiple pregnancies be analysed?
abstract: To compare the effects of four methods of analysis on the results of randomised controlled trials that recruit women with multiple pregnancies and measure outcomes on their babies.
title: Progesterone does not prevent preterm births in women with twins.
abstract: To compare preterm birth rate and neonatal outcome in twin gestations randomized to either 17 alpha-hydroxyprogesterone caproate (17P) or placebo.
title: Salivary progesterone and estriol among pregnant women treated with 17-alpha-hydroxyprogesterone caproate or placebo.
abstract: The objectives of the study was to determine whether salivary progesterone (P) or estriol (E3) concentration at 16-20 weeks' gestation predicts preterm birth or the response to 17alpha-hydroxyprogesterone caproate (17OHPC) and whether 17OHPC treatment affected the trajectory of salivary P and E3 as pregnancy progressed.
title: Plasma CRH measurement at 16 to 20 weeks' gestation does not predict preterm delivery in women at high-risk for preterm delivery.
abstract: The purpose of this study was to examine the utility of a single second-trimester plasma corticotropin-releasing hormone measurement as a marker for preterm delivery in women at high risk for preterm delivery.
title: A randomized trial of micronized progesterone for the prevention of recurrent preterm birth.
abstract: We sought to evaluate the effectiveness of daily oral micronized progesterone (MP) in preventing recurrent spontaneous preterm birth (RSPB) and whether MP increases maternal serum progesterone. We performed a pilot, single-center, randomized, double-blind, placebo-controlled trial in women with a prior preterm birth and current singleton gestation at 16 to 20 weeks ( N = 33). The primary outcome was the rate of RSPB. Subjects were given either daily MP (400 mg) or placebo from 16 to 34 weeks. Serum progesterone was obtained at enrollment and in the late second/early third trimester. Pregnancy outcome data were collected. RSPB occurred in 5/19 (26.3%) in the MP group versus 8/14 (57.1%) in placebo group ( P = 0.15). The mean age at delivery was 37.0 ± 2.7 weeks for the MP group versus 35.9 ± 2.6 weeks for the placebo ( P = 0.3). Mean serum progesterone at 28 weeks was 122.6 ± 61.8 pg/mL for MP group versus 90.1 ± 38.7 pg/mL for placebo ( P = 0.19). MP was associated with a trend toward a reduction in RSPB and an increase in the maternal serum progesterone. Although the primary outcome in this pilot study did not reach statistical significance, the results suggest a favorable trend meriting further investigation.
title: The West Los Angeles Preterm Birth Prevention Project. I. Program impact on high-risk women.
abstract: The primary objective of this prospective study was to test whether preterm birth prevention education plus increased clinic visits and selected prophylactic interventions reduce preterm birth.
title: Does progesterone treatment influence risk factors for recurrent preterm delivery?
abstract: To examine how demographic and pregnancy characteristics can affect the risk of recurrent preterm delivery and the how the effectiveness of progesterone treatment for prevention alters these relationships.
title: 17α-hydroxyprogesterone caproate for the prevention of adverse neonatal outcome in multiple pregnancies: a randomized controlled trial.
abstract: To estimate whether administration of 17α-hydroxyprogesterone caproate can prevent neonatal morbidity in multiple pregnancies by reducing the preterm birth rate.
title: Prevention of preterm delivery after successful tocolysis in preterm labor by 17 alpha-hydroxyprogesterone caproate: a randomized controlled trial.
abstract: The objective of the study was to evaluate the use of 17 alpha-hydroxyprogesterone caproate (17P) to reduce preterm delivery.
title: Prevention of preterm delivery in twin gestations (PREDICT): a multicenter, randomized, placebo-controlled trial on the effect of vaginal micronized progesterone.
abstract: Studies on high-risk singleton gestations have shown a preventive effect of progesterone treatment on preterm delivery. This study was conducted to investigate the preventive effect of vaginal micronized progesterone in a large population of twin gestations.
title: A trial of 17 alpha-hydroxyprogesterone caproate to prevent prematurity in twins.
abstract: In singleton gestations, 17 alpha-hydroxyprogesterone caproate (17P) has been shown to reduce the rate of recurrent preterm birth. This study was undertaken to evaluate whether 17P would reduce the rate of preterm birth in twin gestations.
title: Progesterone effects on preterm birth in high-risk pregnancies: a randomized placebo-controlled trial.
abstract: The purpose of this study was to evaluate whether the prophylactic administration of vaginal progesterone would reduce the preterm birth rate in high-risk population including singleton and twin pregnancies.
title: Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial.
abstract: Women with a sonographic short cervix in the mid-trimester are at increased risk for preterm delivery. This study was undertaken to determine the efficacy and safety of using micronized vaginal progesterone gel to reduce the risk of preterm birth and associated neonatal complications in women with a sonographic short cervix.
title: The effect of 17-alpha hydroxyprogesterone caproate on the risk of gestational diabetes in singleton or twin pregnancies.
abstract: To compare the rates of gestational diabetes among women who received serial doses of 17-alpha hydroxyprogesterone caproate vs placebo.
title: Inefficacy of 17 alpha-hydroxyprogesterone caproate in the prevention of prematurity in twin pregnancy.
abstract: There are indications that prophylactic administration of 17 alpha-hydroxyprogesterone caproate (17 alpha-OHP-C) could be beneficial in the treatment of women at risk for preterm delivery. Since twin pregnancy is commonly associated with prematurity, 77 women with twin pregnancy were treated during the last trimester until the 37th gestational week with weekly injections of either 17 alpha-OHP-C or a placebo, following double-blind principles. The gestational length and birth weight and the outcome of the neonates were similar in both groups. The administration of 17 alpha-OHP-C thus seems ineffective in the prevention of prematurity risks associated with twin pregnancy.
title: Prevention of preterm birth in triplets using 17 alpha-hydroxyprogesterone caproate: a randomized controlled trial.
abstract: To assess whether 17 alpha-hydroxyprogesterone caproate reduces the rate of preterm birth in women carrying triplets.
title: Efficacy of 17α-hydroxyprogesterone caproate in prevention of preterm delivery.
abstract: Preterm delivery is defined as a birth before 37 weeks' gestation and is the cause of two-thirds of perinatal mortality and thus one of the major problems in obstetrics. Its etiology is unknown, but hormonal factors have been reported to play a part. Progesterone is a placental hormone and effective in maintaining pregnancy. The aim of this study is to evaluate the efficacy of 17α-hydroxyprogesterone caproate in the prevention of preterm delivery.
title: Progesterone vaginal gel for the reduction of recurrent preterm birth: primary results from a randomized, double-blind, placebo-controlled trial.
abstract: Preterm birth is the leading cause of perinatal morbidity and mortality worldwide. Treatment of preterm labor with tocolysis has not been successful in improving infant outcome. The administration of progesterone and related compounds has been proposed as a strategy to prevent preterm birth. The objective of this trial was to determine whether prophylactic administration of vaginal progesterone reduces the risk of preterm birth in women with a history of spontaneous preterm birth.
title: Increased doses of vaginal progesterone for the prevention of preterm birth in twin pregnancies: a randomised controlled double-blind multicentre trial.
abstract: Previous trials have shown little benefit for preventing preterm birth in twin pregnancies using 90-200 mg of daily vaginal natural progesterone. Higher doses have not been tested. Our aim was to determine the efficacy and safety of two different daily doses of vaginal natural progesterone (200 and 400 mg), compared with placebo, for preventing preterm birth in unselected twin pregnancies.
title: Oral dydrogesterone treatment during the first trimester of pregnancy: the prevention of miscarriage study (PROMIS). A double-blind, prospectively randomized, placebo-controlled, parallel group trial.
abstract: A planned study to test the hypothesis that dydrogesterone given during the first trimester of pregnancy can positively influence the immune system of women suffering from recurrent miscarriages and thereby lead to successful pregnancies. The primary objective is to show whether the administration of dydrogesterone during the first trimester of pregnancy increases the release of progesterone-induced blocking factor (PIBF) and causes a shift from Th-1 cytokines to Th-2 cytokines. Further objectives are an analysis of pregnancy outcome and to investigate the tolerability and safety of dydrogesterone use during pregnancy.
title: Oral micronized progesterone for prevention of preterm birth.
abstract: To evaluate oral micronized progesterone (OMP) to prevent preterm birth (PTB).
title: Women with preterm premature rupture of the membranes do not benefit from weekly progesterone.
abstract: We sought to determine if 17-alpha-hydroxyprogesterone (17P) extends gestation vs placebo in women with preterm premature rupture of the membranes (PPROM).
title: Intravaginal use of natural micronised progesterone to prevent pre-term birth: a randomised trial in India.
abstract: In a prospective, randomised trial, 100 pregnant women with >/= one prior spontaneous pre-term birth were randomised into two groups. Group 1 women received 100 mg natural micronised progesterone intravaginally once daily from 20-24 weeks' gestation until 36 weeks. Group 2 women did not receive progesterone. Both groups were regularly supervised until delivery. Pre-term birth (<37 and <34 weeks) and other maternal, neonatal outcomes were primary and secondary outcomes, respectively. Chi-square test and Fisher exact test were used to compare categorical variables. Independent sample t-test and one-way ANOVA were used to compare continuous variables and multiple comparisons, respectively. Pre-term births <37 weeks were significantly lower in Group 1 (12% vs 38%, p = 0.002), but pre-term births <34 weeks were similar. The mean birth weight of neonates born to women in Group 1 was significantly higher (2800 vs 2,500 g, p = 0.023). We concluded intravaginal administration of 100 mg of natural micronised progesterone significantly reduced the incidence of pre-term birth <37 weeks in women with > or = one prior pre-term birth. Future research is warranted to assess the long-term safety and efficacy of progesterone.
title: 17-hydroxyprogesterone caproate for twin pregnancy: a double-blind, randomized clinical trial.
abstract: We sought to determine whether prophylactic treatment with 17-alpha-hydroxyprogesterone caproate (17Pc) in twin pregnancy will reduce neonatal morbidity (primary outcome) by prolonging pregnancy (secondary outcome).
title: A randomized trial of cerclage vs. 17 alpha-hydroxyprogesterone caproate for treatment of short cervix.
abstract: To determine pregnancy outcome in patients with short cervix on transvaginal ultrasound between 16 and 24 weeks' gestation treated with McDonald cerclage compared to weekly intramuscular injections of 17 alpha-hydroxyprogesterone caproate (17OHP-C).
title: The preterm prediction study: effect of gestational age and cause of preterm birth on subsequent obstetric outcome. National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network.
abstract: We sought to evaluate the association between prior spontaneous preterm delivery and subsequent pregnancy outcome.
title: Effect of medroxyprogesterone acetate upon the duration and characteristics of human gestation and labor.
title: 17 alpha-hydroxyprogesterone caproate to prevent prematurity in nulliparas with cervical length less than 30 mm.
abstract: We sought to evaluate whether 17 alpha-hydroxyprogesterone caproate (17-OHP) reduces preterm birth (PTB) in nulliparous women with a midtrimester cervical length (CL) <30 mm.
title: Progesterone for prevention of recurrent preterm birth: impact of gestational age at previous delivery.
abstract: Preterm birth occurs in 1 of 8 pregnancies and may result in significant morbidity and mortality. 17-alpha hydroxyprogesterone caproate (17-OHP caproate) has been found to be efficacious in reducing the risk of subsequent preterm delivery in women who have had a previous spontaneous preterm birth (sPTB). This analysis was undertaken to evaluate if 17-OHP caproate therapy works preferentially depending on the gestational age at previous spontaneous delivery. We hypothesized that treatment with 17-OHP caproate is more effective in prolonging pregnancy depending on the gestational age of the earliest previous preterm birth (20-27.9, 28-33.9 vs 34-36.9 weeks).
title: Effect of progesterone as a tocolytic and in maintenance therapy during preterm labor.
abstract: To assess the efficacy of vaginal micronized natural progesterone as a tocolytic and in maintenance therapy during threatened preterm birth.
title: Hospital admissions in the first year of life in very preterm infants.
abstract: To analyse hospital readmissions to 1 year in infants < 33 weeks' gestation.
title: 17alpha-hydroxy-progesterone effects on cervical proinflammatory agents in women at risk for preterm delivery.
abstract: We evaluated if the inhibitory effect of 17alpha-hydroxyprogesterone caproate (17P) on cervical ripening is mediated by cervical proinflammatory agents. Women with singleton pregnancy and intact membranes, between 25 and 33 weeks + 6 days, were randomly allocated either to observation (22 cases, controls) or to receive 341 mg of intramuscular 17P (23 cases, 17P group), twice a week, until 36 weeks. Just before randomization, 7 and 21 days later, a cervical swab for interleukin (IL)-1beta, IL-6, IL-8, tumor necrosis factor alpha (TNF-alpha), and nitrates/nitrites (NOx) assays was collected. Moreover, an ultrasound measure of cervical length (CL) was performed at the same time. At randomization, both groups of women showed similar levels of cervical ILs and NOx. In the 17P group, cervical IL-1beta levels were significantly decreased at day 21 ( P = 0.036); in controls, they remained stable throughout the observation period. There was no significant change in IL-6, IL-8, TNF-alpha, and NOx in either group. Women in the control group had a progressive CL shortening until day 21 (median shortening of 4 mm), and this shortening was significantly less in the 17P group (median shortening of 2 mm; P = 0.017). In patients at risk of preterm labor, high-dose 17P simultaneously inhibits both cervical proinflammatory IL-1beta secretion and the progressive shortening of the cervix.
title: [Intention-to-treat].
abstract: What is meant by intention-to-treat? Why should data be analyzed in controlled trials in a way that all participants are included in the group to which they were randomly assigned, regardless of whether they completed the intervention given to the group? In this Tutorial, the logic of the intention-to-treat principle is outlined. It is shown that study results may be biased by excluding patients post hoc thus producing spurious effects that do not exist in the population under study. The intention-to-treat strategy avoids this bias.