bluuebunny/crossref_metadata_2025 huggingface dataset:
Oral versus intra‐vaginal imidazole and triazole anti‐fungal agents for the treatment of uncomplicated vulvovaginal candidiasis (thrush): a systematic review
Authors: Watson Margaret C. , Grimshaw Jeremy M. , Bond Christine M. , Mollison Jill , Ludbrook Anne
Published: December 2003

Objectives
To compare the relative effectiveness, cost effectiveness and safety of oral versus intra‐vaginal anti‐fungal treatments for uncomplicated vulvovaginal candidiasis (thrush) and establish patient preference for the route of anti‐fungal administration

Design
A systematic review of studies comparing oral and intra‐vaginal anti‐fungal treatments for uncomplicated vulvovaginal candidiasis. Standard Cochrane Collaboration methods were used

Data sources
The following sources were searched: the Cochrane Controlled Trials Register; the Cochrane Sexually Transmitted Disease review group Specialised Register of Controlled Trials; EMBASE (January 1980 to January 2000); and MEDLINE (January 1985 to May 2000). The reference list of each trial was checked for additional references. The manufacturers of anti‐fungal treatments in the UK were asked for information on trials fulfilling the inclusion criteria

Methods
There was duplicate, independent examination and selection of the electronic search results followed by duplicate data abstraction. Disagreements regarding inclusion status and data abstraction were resolved by discussion between reviewers and the editor of the Cochrane Sexually Transmitted Disease group. Randomised controlled trials conducted worldwide and published in any language were included. The primary outcome measure was clinical cure. Mycological cure, patient preference and safety were secondary outcome measures

Results
Seventeen trials were included in the review, reporting 19 oral versus intra‐vaginal anti‐fungal treatment comparisons. No statistically significant differences were shown between oral and intra‐vaginal anti‐fungal treatment for clinical or mycological cure. All 10 trials that reported a preference favoured oral treatment (compared with intra‐vaginal or no preference). No trials presented cost data

Conclusions
There is no difference between the relative effectiveness of oral and intra‐vaginal anti‐fungal treatment for thrush
Perineal ultrasound evaluation of urethral angle and bladder neck mobility in women with stress urinary incontinence
Authors: Pregazzi Roberto , Sartore Andrea , Bortoli Paolo , Grimaldi Eva , Troiano Luigi , Guaschino Secondo
Published: December 2003

Objectives
1. To assess the reproducibility of an electronic ultrasonographic technique for the measurement of urethral angulation; 2. To test the ability of measurement of the urethral angle and bladder neck mobility to predict genuine stress incontinence; 3. To compare ultrasound variables in stress incontinent women and in controls.

Design
Case–control study.

Population
Twenty‐three incontinent women and 50 controls.

Methods
Electronic measurements of the distance between the bladder neck and the symphysis pubis, the bladder neck and the symphysis pubis line and the midline of the symphysis (alpha angle) and the angle between the proximal and distal urethra (beta angle) by means of perineal ultrasonography with a comfortably full bladder at rest, during the Valsalva manoeuvre and during maximal pelvic floor contraction. The same procedure was performed by a second investigator. Repeatability was evaluated by the technique described by Bland and Altman. Statistical analysis was performed using Student's t test and the two‐tailed paired t test.

Main outcome measures
To test the possible role of the urethral angle in maintaining female continence.

Results
Ultrasound analysis showed good repeatability between the two observers and is not influenced by vesical volume. Beta angle and urethrovesical mobility are inversely proportional, both in continent and in incontinent women. Urethral angle identifies genuine stress incontinence better than urethrovesical mobility (sensitivity 96%vs 87%; specificity 92%vs 68%; positive predictive value 85%vs 55%). There are significant differences in all ultrasound variables between incontinent women and continent controls.

Conclusions
This study suggests a significant role of the urethral angle in maintaining female continence (in incontinent women it is lower at rest and lowers with straining). Measurement of the urethral angle can provide useful additional information to that provided by ultrasound evaluation of bladder neck mobility.
Intrauterine 10μg and 20μg levonorgestrel systems in postmenopausal women receiving oral oestrogen replacement therapy: clinical, endometrial and metabolic response
Authors: Raudaskoski T. , Tapanainen J. , Tomás E. , Luotola H. , Pekonen F. , Ronni‐Sivula H. , Timonen H. , Riphagen F. , Laatikainen T.
Published: December 2003

Objective
The clinical and endometrial efficacy and lipid response of two different doses of intrauterine levonorgestrel were assessed in comparison with sequential oral medroxyprogesterone acetate in postmenopausal women receiving continuous oral E2‐valerate.

Design
One‐year prospective multicentre randomised control trial.

Setting
Four outpatient clinics in Oulu, Helsinki and Jyväskylä, Finland.

Population
A total of 163 healthy volunteer postmenopausal women with climacteric complaints or already using hormone replacement therapy (HRT).

Interventions
Subjects were randomly allocated to receive a new intrauterine system releasing 10μg of levonorgestrel daily or an established intrauterine system (Mirena) releasing 20μg of levonorgestrel daily or sequential oral medroxyprogesterone acetate (5mg/day, 14/30 days). All three regimens were combined with an oral daily dose of 2mg of E2‐valerate.

Main outcome measures
Bleeding patterns were assessed by diaries kept by the subjects. Endometrial effects were evaluated by histologic biopsies taken at the baseline and after six and 12 months of therapy. Serum concentrations of total, HDL and LDL cholesterol, triglycerides and lipoprotein(a) were determined at the baseline and after six and 12 months of therapy.

Results
Insertion of the smaller 10μg levonorgestrel system was easy in 70% and difficult in 4% and that of Mirena was easy in 46% and difficult in 21% of the subjects. After six months of therapy, 43 (95.6%) of the 47 subjects receiving 10μg levonorgestrel and 54 (98.2%) of the 55 subjects receiving 20μg levonorgestrel had no bleeding, while the sequential medroxyprogesterone acetate regimen produced typical cyclic withdrawal bleedings. Endometrial hyperplasia was not observed in any of the treatment groups during the 12‐month study. After 12 months of therapy, strong endometrial suppression was found in 46/47 and 55/55 of the subjects receiving 10μg and 20μg of levonorgestrel, respectively, while the endometrium was proliferative in 18/47 of the subjects in the medroxyprogesterone acetate group. Serum total cholesterol decreased in all treatment groups. HDL cholesterol increased in women receiving medroxyprogesterone acetate or the smaller intrauterine dose of levonorgestrel.

Conclusions
Both intrauterine doses of levonorgestrel provided good endometrial protection in postmenopausal women on oestrogen replacement therapy. The advantage of the 10μg system with a smaller size is the easier insertion of the system and a minimal attenuation of the favourable effects of oral oestrogen on the serum lipid profile.
The association of pre‐eclampsia with the Duffy negative phenotype in women of West African descent
Authors: Velzing‐Aarts Francien V. , van der Dijs Fey P.L. , Muskiet Frits A.J. , Duits Ashley J.
Published: December 2003

Objective
To investigate whether pre‐eclampsia in Curaçao is associated with the Duffy negative phenotype.

Design
Retrospective study.

Setting

Population

Methods

Results
Women with a history of pre‐eclampsia had a higher Duffy negative phenotype frequency compared with women with a history of uncomplicated pregnancies (52.8 vs 27.3%, respectively; odds ratio 2.98; 95% CI 1.40–6.32; P= 0.004).

Conclusions
Pre‐eclampsia is associated with the Duffy negative phenotype in women of West‐African descent in the island of Curaçao.
Rates of bacterial vaginosis in women undergoing in vitro fertilisation for different types of infertility
Authors: Wilson Janet D. , Ralph Susan G. , Rutherford Anthony J.
Published: December 2003

Objective
To assess whether the rate of bacterial vaginosis (BV) is higher in women with tubal factor infertility compared with those with other causes of infertility.

Design
Cross‐sectional study.

Setting
Assisted conception unit of a teaching hospital in Leeds.

Population
Consecutive women undergoing in vitro fertilisation.

Methods
Women undergoing in vitro fertilisation (IVF) had a vaginal smear taken at the time of their egg collection. The smear was Gram‐stained and graded as normal, intermediate or BV.

Main outcome measures
The presence of bacterial vaginosis and the causes of infertility.

Results
A total of 749 women were included. The vaginal smears were normal in 63.6%, intermediate in 12.1%, and BV in 24.3%. The rates of BV in women with different types of infertility were 36.4% in tubal factor, 15.6% in male factor, 33.3% in anovulation, 12.5% in endometriosis and 18.9% in unexplained infertility. After controlling for the effects of age and smoking using a multivariate logistic regression model, women with tubal infertility were significantly more likely to have BV than women with endometriosis OR 3.63 (95% CI 1.52–8.67); male factor OR 2.98 (95% CI 1.80–4.90); and unexplained infertility OR 2.20 (95% CI 1.35–3.59). The adjusted figures for the increase of BV in women with anovulation were: endometriosis OR 3.77 (95% CI 1.28–11.08); male factor OR 3.09 (95% CI 1.37–6.96); and unexplained infertility OR 2.29 (95% CI 1.02–5.12).

Conclusions
Women with tubal infertility were three times more likely to have BV than women with endometriosis, male factor or unexplained infertility. These findings support the association between BV, pelvic inflammatory disease (PID) and tubal damage but do not help distinguish between cause and effect. Women with anovulation were also three times more likely to have BV than women with endometriosis or male factor infertility, supporting suggestions of hormonal influence on vaginal flora.
Differential expression of matrix metalloproteinase and tissue inhibitor of MMP in serosal tissue of intraperitoneal organs and adhesions
Authors: Chegini Nasser , Zhao Yong , Kotseos Kristina , Ma Chunfeng , Bennett Barbara , Diamond Michael P. , Holmdahl Lena , Skinner Kevin ,   Members of the The Peritoneal Healing and Adhesion Multi University Study (PHAMUS) Group are listed on page 1048
Published: December 2003

Objective
To comparatively analyse the expression of matrix metalloproteinase (MMP‐3) and tissue inhibitor of MMP (TIMP‐2) in serosal tissue of intraperitoneal organs and adhesions, as well as peritoneal fluid and serum of subjects with and without adhesions.

Design
Cross sectional study.

Setting
Academic research centres.

Sample
Patients undergoing abdominal/pelvic surgery.

Methods
Messenger ribonucleic acid (mRNA) and protein expression using quantitative reverse transcription polymerase chain reaction (Q‐RT‐PCR), ELISA and immunohistochemistry.

Results
All the tissues examined express MMP‐3 and TIMP‐2 mRNA and protein at consistently varying levels ranging from 100‐ to 1000‐fold and 2‐ to 10‐fold mRNA and protein, respectively. Serosa of uterine, fallopian tube, ovary and partial peritoneum express a higher MMP‐3 mRNA compared with small and large bowels and omentum, while TIMP‐2 expression was less variable with the highest level found in uterine serosa (P < 0.05). The expression of MMP‐3 and TIMP‐2 mRNA in adhesions was not significantly different compared with parietal peritoneum. MMP‐3 and TIMP‐2 protein content in tissue extracts, peritoneal fluids and serum also varied with higher TIMP‐2 than MMP‐3 (P < 0.05). TIMP‐2 levels were lower in serum of subjects with moderate/extensive adhesions compared with subjects without adhesions. Immunoreactive MMP‐3 and TIMP‐2 proteins were detected in various cell types in these tissues. There was no correlation between MMP‐3 and TIMP‐2 expression, and age, gender or menstrual status of subjects with or without adhesions.

Conclusion
MMP‐3 and TIMP‐2 are expressed at varying levels in serosal tissues of peritoneal organs and adhesions, with higher TIMP‐2 than MMP‐3. Based on the knowledge that tissue injury alters the expression of MMPs and TIMPs, such variations may predispose an organ to develop more adhesions than others. In addition, the results suggest that serum level of TIMP‐2 may represent a marker for subjects who will form adhesions with greater severity.
Iron plus folate is more effective than iron alone in the treatment of iron deficiency anaemia in pregnancy: a randomised, double blind clinical trial
Authors: Juarez‐Vazquez Jorge , Bonizzoni Erminio , Scotti Aurelio
Published: December 2003

Objective
To evaluate whether folate supplementation to iron is able to accelerate solving of iron deficiency anaemia in pregnancy.

Design
Multicentre, double blind, randomised clinical trial.

Setting
Nine hospital gynaecologic units located in Mexico.

Population
Three hundred seventy‐one women with iron deficiency anaemia between 14 and 27 weeks of pregnancy.

Methods
Random allocation of the study population to receive 80 mg iron proteinsuccinylate, with or without 0.370 mg folinic acid daily for 60 days.

Main outcome measure
Haemoglobin concentration increase.

Results
Combined iron and folate therapy showed a better therapeutic response: the increase in haemoglobin levels from baseline was 1.42 (0.14) g/dL for women treated with both compounds vs 0.80 (0.125) g/dL for those given iron only (P < 0.001). A multivariable regression analysis showed that this effect was independent of basal levels of blood iron, ferritine and serum folate and was more evident in women with more severe anaemia. In the 64 women belonging to the subgroup defined by the per‐protocol (PP) population and the lowest quartile of baseline haemoglobin values (mean 8.96, range 5.9–9.8 g/dL), the increase at day 60 was estimated 2.3 (0.53) g/dL for the combined therapy vs 0.5 (0.5) g/dL for iron only (P= 0.07). No significant differences in tolerability were observed between the two groups.

Conclusion
Folate supplementation is recommended in pregnant women with iron deficiency anaemia irrespective of the serum levels of folate.
Fetal bradycardia due to intrathecal opioids for labour analgesia: a systematic review
Authors: Mardirosoff Chahé , Dumont Lionel , Boulvain Michel , Tramèr Martin R.
Published: December 2003

Objective
To evaluate fetal and maternal adverse effects of intrathecal opioid analgesia during labour.

Data sources
A systematic search was performed, in Medline, Embase, the Cochrane Library, bibliographies, and personal contact with authors, in any language, up to February 2001.

Study selection
Full reports on randomised comparisons of any analgesia with intrathecal opioid (experimental group) with any non‐intrathecal opioid regimen (control group) during labour.

Data extraction
Dichotomous data from 24 trials (3513 women).

Results
With intrathecal opioids, there was a significant increase in the risk of fetal bradycardia: odds ratio 1.8 (95% confidence interval 1.0 to 3.1), number‐needed‐to‐harm 28. The risk of caesarean section due to fetal heart rate abnormalities was similar (6.0%versus 7.8%). The incidence of pruritus was significantly higher with intrathecal opioids: relative risk 29.6 (95% CI 13.6 to 64.6), number‐needed‐to‐harm 1.7.

Conclusions
Intrathecal opioids for labour increase the risk of fetal bradycardia and maternal pruritus. The risk of subsequent caesarean section is not increased.
Predictive value of amniotic fluid cystatin C levels for the early identification of fetuses with obstructive uropathies
Authors: Mussap Michele , Fanos Vassilios , Pizzini Carla , Marcolongo Alma , Chiaffoni Graziella , Plebani Mario
Published: December 2003

Objective
To compare the diagnostic accuracy of cystatin C with that of creatinine in discriminating renal function in fetuses without ultrasononographic evidence of renal malformations from those with obstructive uropathies.

Design
Prospective, observational cohort study.

Setting
Prenatal morphologic and functional evaluation of fetal obstructive uropathies throughout pregnancy.

Population
A total of 96 healthy pregnant women at different stages of pregnancy, without any pregnancy‐related maternal disease. Eighty‐one pregnant women without clinical and ultrasonographic evidence of any fetal anomaly, confirmed at birth, were defined as controls; 15 pregnant women with various fetal obstructive uropathies, evidenced by repeated ultrasound examinations and confirmed at birth, were defined as cases.

Methods
Creatinine was measured by a kinetic Jaffe picric acid method and cystatin C by a nephelometric immunoassay. Variables were analysed by applying conventional statistical tests; the non‐parametric receiver operating curves (ROC) analysis was used to evaluate the diagnostic efficiencies of the biochemical markers.

Main outcome measures
Incidence of confirmed, diagnosed, neonatal obstructive uropathy by measuring baseline levels of cystatin C and creatinine in amniotic fluid.

Results
Baseline levels of cystatin C in amniotic fluid were significantly higher (P= 0.0015) among cases than in controls with comparable gestational age; no significant difference was found for creatinine levels (P= n.s.). The maximum diagnostic accuracy of serum cystatin C in discriminating controls from fetal uropathies was 96%, while that of creatinine was 62%.

Conclusion
Cystatin C may be considered a sensitive biochemical marker for the early identification of fetuses with obstructive uropathies.
Soluble P‐selectin levels during normal pregnancy: a longitudinal study
Authors: Holmes V.A. , Wallace J.M.W. , Gilmore W.S. , McFaul P. , Alexander H.D.
Published: December 2003

Objective
To investigate soluble P‐selectin (sP‐selectin) levels and platelet parameters in normal pregnant women compared with non‐pregnant control subjects.

Design
A longitudinal case–control study.

Setting
Obstetric outpatient clinic in the Jubilee Maternity Hospital, Belfast.

Population
One hundred and twenty normal pregnant women and 41 non‐pregnant age‐matched control subjects.

Methods
The plasma concentration of sP‐selectin in pregnant women sampled at 12, 20 and 35 weeks of gestation, and, in a subgroup at three days postpartum, and non‐pregnant controls sampled in parallel, was determined using a commercial quantitative sandwich immunoassay kit. Platelet parameters on each blood sample were also recorded using a SYSMEX SE 9500 analyser.

Main outcome measures
Plasma sP‐selectin as a measure of platelet activation in normal pregnancy.

Results
Soluble P‐selectin was significantly higher in pregnant women than in non‐pregnant control subjects at 20 and 35 weeks of gestation, (P < 0.01, and P < 0.001, respectively). Correlation analyses showed positive correlation between sP‐selectin and platelet count in pregnant women at 20 and 35 weeks of gestation (r= 0.247, P < 0.05 and r= 0.360, P < 0.001, respectively). Soluble P‐selectin concentration per platelet was also significantly higher in pregnant women than in non‐pregnant control subjects at 20 and 35 weeks of gestation (P < 0.001).

Conclusions
Our results show that sP‐selectin concentration is significantly higher in the second and third trimester of pregnancy when compared with non‐pregnant control subjects sampled in parallel. This finding clarifies previous conflicting results on platelet activation in normal pregnancy, and is in agreement with those earlier studies which reported, using other methods, increased platelet activation in normal pregnancy.
Herpes simplex virus type‐2 infection in pregnancy: no risk of fetal death: results from a nested case–control study within 35,940 women
Authors: Eskild Anne , Jeansson Stig , Stray‐Pedersen Babill , Jenum Pål A.
Published: December 2003

Objective
The aim of this study was to assess the association of fetal death with herpes simplex virus type‐2 (HSV‐2) antibody status during pregnancy: 1. presence of antibodies in first trimester; 2. appearance of antibodies (incident infection); 3. increase in antibody titre; and 4. loss of antibodies.

Design
Prospective study.

Population
The source population was a cohort of 35,940 pregnant women in Norway.

Methods
Nested case–control study within the cohort. Cases were all women in the study population who experienced a fetal death after the 16th weeks of gestation (n= 281), and controls were 961 randomly selected women with a live born child.

Main outcome measures
HSV‐2 antibody status.

Results
Twenty‐nine percent (82/281) of women with a fetal death and 27% (256/961) of the controls had of HSV‐2 antibodies present in the first trimester (odds ratio 1.1, 95% CI 0.8–1.5). HSV‐2 antibodies appeared in 2% (3/136) of initially seronegative cases and 3% (16/623) of the controls during pregnancy (odds ratio 0.9, 95% CI 0.2–3.0). An increase in HSV‐2 antibodies occurred in 4% (2/55) of initially seropositive cases and 7% (16/231) of the controls (odds ratio 0.5, 95% CI 0.1–2.3). Loss of HSV‐2 antibodies in initially seropositive women was not associated with fetal death, 42% (23/55) of the cases and 45% (104/231) of the controls seroreverted (odds ratio 0.8, 95% CI 0.5–1.6). Differences in follow up time, age and parity were controlled and did not influence the comparisons between cases and controls.

Conclusion
This study provides no evidence of an association between HSV‐2 infection during pregnancy and fetal death.
Dose–response analysis of effects of tibolone on climacteric symptoms
Authors: Landgren M.B. , Bennink H.J.T. Coelingh , Helmond F.A. , Engelen S.
Published: December 2003

Objective
To assess the clinically optimal tibolone dose for the relief of climacteric complaints.

Design
A randomised, double blind, placebo‐controlled trial.

Setting
Twenty‐eight centres in Norway, The Netherlands, Sweden and Finland.

Population
Seven hundred and seventy‐five healthy postmenopausal women were randomised to tibolone in a daily dose of 0.625, 1.25, 2.5 or 5.0 mg or placebo for 12 weeks.

Methods
At baseline, and after 4, 8 and 12 weeks, hot flushes, sweating, vaginal bleeding and adverse experiences were recorded.

Main outcome measures
Change in frequency and intensity of hot flushes and sweating over 12 weeks.

Results
From week four onwards, 2.5 and 5.0 mg tibolone were significantly more effective than placebo, regarding the frequency of hot flushes and sweating (P < 0.001), whereas the 0.625 mg dose was not significantly different from placebo during the study. The frequency of hot flushes with the 1.25 mg dose was statistically significantly different from placebo, only from week eight onwards. The incidence of dropouts due to insufficient therapeutic effect was much higher in the tibolone 1.25 mg group (9.5%) than in the 2.5 (1.9%) and 5.0 mg (1.3%) groups. A dose‐related increase in incidence of vaginal bleeding or spotting was observed (P < 0.0001). Bleeding incidence in the 5.0 mg dose group was about twice as high as in the 2.5 mg dose group. There was no difference in incidence of adverse experiences between the 2.5‐ and the 1.25 mg dose group.

Conclusion
A daily dose of 2.5 mg tibolone is the clinically optimal dose for the treatment of climacteric complaints in postmenopausal women.
Risk of partial and complete hydatidiform molar pregnancy in relation to maternal age
Authors: Sebire N.J. , Foskett M. , Fisher R.A. , Rees H. , Seckl M. , Newlands E.
Published: December 2003

All cases of first histologically confirmed complete and partial moles registered between 1985 and 1999 were identified from the database of a Trophoblastic Disease Registration Centre. The maternal age distribution at diagnosis was calculated for the 7916 molar pregnancies and compared with the maternal age distribution of an unselected population of women from a routine obstetric database. Likelihood ratios were calculated for complete and partial molar pregnancies by maternal age. A positive relationship was found between the risk of molar pregnancy and both upper and lower extremes of maternal age (≥45 years and ≤15 years, respectively). This association, although present for both complete and partial moles, is much greater for complete mole at all maternal ages, and the degree of risk is much greater with older (≥45 years) rather than younger (≤15 years) maternal age. This study provides, for the first time, data regarding specific risk of partial versus complete hydatidiform mole with maternal age.
Erythromycin inhibits prostaglandin F2α‐induced contractions of myometrium isolated from non‐pregnant rats
Authors: Celik Husnu , Ayar Ahmet , Baltaci Abdulkerim , Tug Niyazi
Published: December 2003

Objective
The aim of this study was to investigate the effects of erythromycin on prostaglandin F2α (PGF2α)‐induced contractions of isolated myometrial strips from non‐pregnant rats.

Design
In vitro pharmacological study.

Setting
Firat University Faculty of Medicine.

Sample
Myometrium samples were taken from 55 adult Wistar rats.

Methods
Myometrial strips were isolated from mature, non‐pregnant Wistar rats. Isometric contractions of these strips were induced with 1 μM PGF2α. Effects of 0.01, 0.1, 0.2, 0.5 and 1 mM erythromycin on the frequency and amplitude of these PGF2α‐induced contractions were recorded.

Main outcome measures
The inhibition of prostaglandin F2α‐induced contractions in vitro.

Results
Application of 0.01 mM erythromycin had no effect on either amplitude or frequency of contractions. However, 0.1, 0.2, 0.5 and 1 mM erythromycin decreased the frequency and amplitude of PGF2α‐induced contractions. The inhibitory effect of erythromycin on amplitude was 27%, 38%, 54% and 83% (P < 0.05), and that on frequency was 10%, 16%, 32% and 61% (P < 0.05) at 0.1, 0.2, 0.5 and 1 mM concentrations, respectively.

Conclusion
The results of this study demonstrate that erythromycin inhibits PGF2α‐induced contractions in rat myometrium. Because PGF2α‐induced contractions have been suggested to be involved in the pathogenesis of primary dysmenorrhoea, effects of erythromycin in this clinical entity may present a new approach for the treatment.
Comparative study of the effects of a progestogen‐only pill containing desogestrel and an intrauterine contraceptive device in lactating women
Authors: Bjarnadóttir Ragnheidur I. , Gottfredsdóttir Helga , Sigurdardóttir Kristín , Geirsson Reynir T. , Dieben Thom O. M.
Published: December 2003

Objective To evaluate the effects of desogestrel 75μg/day, as a progestogen‐only pill compared with a copper‐bearing intrauterine contraceptive device (IUCD) on lactation and to study the safety of both treatments in mothers and children. Transfer of etonogestrel to breast milk was studied in a subgroup of desogestrel users. The children were to be followed up until 2.5 years of age.

Design An open, non‐randomised, group‐comparative study in lactating women.

Setting University Hospital, Reykjavik, Iceland.

Participants A total of 83 lactating women; 42 received desogestrel and 41 had an IUCD inserted for seven consecutive treatment cycles of 28 days.

Methods Evaluation visits were planned at baseline and at the end of treatment cycles 1, 4 and 7. The amount of breast milk was determined by weighing the infants before and after feeding, at baseline and after treatment cycles 1 and 4. Milk samples were obtained at the same time for constituent measurements. Safety was studied by structured medical examinations and by recording adverse experiences in mothers and children.

Results There were no significant differences between the desogestrel and IUCD groups in composition and quantity of breast milk nor in growth and development of the children followed up to the age of 2.5 years. In the desogestrel group a slightly higher incidence of mild adverse experiences of a hormonal nature was reported among both mothers and infants. Of the children 82% were followed until 1.5 years of age and 50% until 2.5 years.

Conclusion The use of desogestrel 75μg/day did not change the amount and composition of breast milk nor did it affect growth and development of the breastfed children. It appears to be a safe and effective contraceptive method for lactating women
Postnatal quality of life assessment: validation of the Mother‐Generated Index
Authors: Symon Andrew , McGreavey Jacqui , Picken Carol
Published: December 2003

Quality of life is multifactorial, but may not be adequately assessed using existing validated health measures. The Mother‐Generated Index, a subjective tool to measure postnatal quality of life, was assessed in a study of 102 women in Tayside, Scotland. They specified the most important areas of their lives having had a baby, and scored these. The Index showed good correlation with established measures of physical and psychological wellbeing, and accurately tracked attitudes towards the baby and the partner. Face, criterion and construct validity were all demonstrated. As both content and scoring are subjectively determined, the Index encourages a holistic assessment.
Glomerular endotheliosis in normal pregnancy and pre‐eclampsia
Authors: Strevens Helena , Wide‐Swensson Dag , Hansen Alastair , Horn Thomas , Ingemarsson Ingemar , Larsen Svend , Willner Julian , Olsen Steen
Published: December 2003

Objective
To investigate the proportion of women with findings characteristic for pre‐eclampsia, as opposed to renal disease, in a controlled study of hypertensive pregnant women undergoing antepartum renal biopsy.

Design
An observational prospective controlled study.

Setting
University Hospital of Lund, Sweden.

Sample
Thirty‐six previously healthy women with hypertensive disease in pregnancy, consecutively admitted to the antenatal ward at onset of disease during a 20 month period and giving informed consent, as well as 12 voluntary healthy pregnant controls.

Methods
Renal biopsy samples were obtained from all participants and evaluated by light microscopy, electron microscopy and immunofluorescence techniques.

Main outcome measures
Presence and degree of glomerular endotheliosis.

Results
Glomerular endotheliosis was present in all women with pre‐eclampsia and gestational hypertension, and in 5 of the 12 controls, although significant differences in the degree of endotheliosis were found between the groups. Clinically undetected renal disease was not diagnosed in any of the women.

Conclusion
Glomerular endotheliosis was found in women with normal pregnancy as well as in both non‐proteinuric and proteinuric hypertension and is consequently not, as earlier believed, pathognomonic for pre‐eclampsia. The transition between normal term pregnancy, gestational hypertension and pre‐eclampsia appears to be a continuous process, perhaps of increasing adaptation to pregnancy. Pre‐eclampsia may be the extreme of the adaptational process, rather than a separate abnormal condition. Clinically undetected renal disease could be a rare cause of hypertension in pregnancy.
Reproductive health in rural Malawi: a population‐based survey
Authors: van den Broek N.R. , White S.A. , Ntonya C. , Ngwale M. , Cullinan T.R. , Molyneux M.E. , Neilson J.P.
Published: December 2003

Objectives
To assess pregnancy outcome, maternal mortality and health‐seeking behaviour in a rural African population and to assess the effects on these of women's education, distance from a health centre and household type.

Design
Descriptive population‐based study.

Setting
A rural community in southern Malawi.

Population
All women living in the catchment area of a rural health centre.

Methods
Interviews with women in 20,649 households using structured questionnaires.

Main outcome measures
Pregnancy outcome, the effect of women's education, distance from a health centre and household type on pregnancy outcome, maternal morbidity and estimates of maternal and perinatal mortality.

Results
Educational level was lower for women than for men. A significant association was found between educational level and fertility. Women aged 45–49 reported an average of six pregnancies with four resulting in currently living children. Successful pregnancy outcome was more likely with increased education and if the woman lived closer to the health centre. Despite living an average of 5 km from the health centre, over 90% of women attended antenatal clinic with a mean of five visits. Assistance at delivery by a trained health care worker was more likely as education increased and was less likely as distance from the health centre increased. Maternal mortality was reported at 413 per 100,000 deliveries (95% CI 144–682). The perinatal mortality rate in this population was estimated at 30 per 1000. An increased perinatal mortality was noted for women who were delivered by a female relative. Perinatal mortality rates were similar for delivery by a traditional birth attendant or a trained nurse–midwife. Education and proximity to the health centre were both associated with improved outcome.

Conclusions
Many women in this rural community suffer the consequences of high pregnancy loss. Maternal and perinatal mortality are high. Improved education and skilled assistance at delivery can result in improved pregnancy outcome. Proximity of any household to a health centre has an effect on outcomes.
A randomised controlled trial of educational counselling on the management of women who have suffered suboptimal outcomes in pregnancy
Authors: Tam Wing Hung , Lee Dominic Tak Sing , Chiu Helen Fung Kum , Ma Kwok Chiu , Lee Albert , Chung Tony Kwok Hung
Published: December 2003

Objectives
To study whether proactive educational counselling, in addition to routine clinical care, reduces psychological morbidity and improves quality of life and client satisfaction among women who suffer suboptimal outcomes during childbirth.

Design
A randomised controlled trial.

Setting
Obstetric unit of a tertiary teaching hospital.

Population
Women who had unexpected antenatal, intrapartum or postpartum events leading to suboptimal outcomes during pregnancy and childbirth.

Intervention
Educational counselling provided by a trained research nurse in the postnatal ward after delivery. Women in the control group received routine clinical care.

Main outcome measures
The Hospital Anxiety and Depression Scale, the General Health Questionnaire and the Clinical Global Impression (before and after counselling, at six weeks and six months post‐delivery) and the World Health Organisation Quality of Life scale (WHO‐QOL) (at six weeks and six months post‐delivery).

Results
There was no significant difference in psychological morbidity, quality of life or client satisfaction between the counselling group and the control group. Participants who underwent elective caesarean section and who had the educational counselling had significantly lower depression scores [mean 2.6 (SD 2.6)] compared with those receiving routine care [mean 3.9 (SD 3.2)]. On the other hand, educational counselling may have deleterious effect to women's quality of life in those who had instrumental delivery. Participants allocated to the counselling group had a lower mean score 68 (SD 13) in the physical domain of WHO‐QOL than those in the intervention group 74 (SD 13).

Conclusion
Educational counselling, given on top of routine clinical care, does not give additional beneficial effects on the psychological wellbeing and quality of life of women who encountered suboptimal outcomes during pregnancy.
Saline contrast hysterosonography in abnormal uterine bleeding: a systematic review and meta‐analysis
Authors: de Kroon Cornelis D. , de Bock Geertruida H. , Dieben Sandra W.M. , Jansen Frank Willem
Published: December 2003

Objective
To assess the diagnostic accuracy of saline contrast hysterosonography in the evaluation of the uterine cavity in women complaining of abnormal uterine bleeding.

Design
A systematic review and meta‐analysis of diagnostic studies that compared saline contrast hysterosonography to a gold standard diagnosis based on either hysteroscopy with or without histological sampling or to hysterectomy.

Setting
University Hospital.

Sample
Twenty‐four studies (including 2278 procedures).

Methods
Electronic databases were searched for relevant studies and references were cross checked. Validity was assessed and data were extracted independently by two authors. Heterogeneity was calculated, studies were plotted in an ROC area and data were pooled. Subgroup analysis was performed according to the validity area.

Main outcome measures
The success rate of saline contrast hysterosonography. The pooled sensitivity, specificity, likelihood ratio's and post‐test probabilities of saline contrast hysterosonography on the prediction of uterine cavity abnormality.

Results
The largest population of homogeneous data were the studies with complete verification. In these studies, the pooled sensitivity and pooled specificity of saline contrast hysterosonography in uterine cavity evaluation were respectively 0.95 (95% CI 0.93 to 0.97) and 0.88 (95% CI 0.85 to 0.92), the likelihood ratios were respectively 8.23 (95% CI 6.2 to 11) and 0.06 (95% CI 0.04 to 0.09) and the post‐test probabilities were respectively 0.91 (95% CI 0.89 to 0.94) and 0.07 (95% CI 0.04 to 0.10). The overall success rate of saline contrast hysterosonography was 93% (95% CI 92% to 94%). The feasibility of saline contrast hysterosonography in postmenopausal women (success rate 86.5%, 95% CI 83.2 to 89.8) is significantly lower (P < 0.01) compared with premenopausal women (success rate 95%, 95% CI 94% to 96%).

Conclusion
Saline contrast hysterosonography is accurate in the evaluation of the uterine cavity in pre‐ and postmenopausal women suffering from abnormal uterine bleeding. The feasibility of saline contrast hysterosonography is high, although significantly better in premenopausal women compared with postmenopausal women. We conclude that saline contrast hysterosonography, in combination with an endometrium aspiration if necessary, can become the standard diagnostic procedure in women with abnormal uterine bleeding.
Assessment of fetal liver volume and umbilical venous volume flow in pregnancies complicated by insulin‐dependent diabetes mellitus
Authors: Boito Simona M. , Struijk Piet C. , Ursem Nicolette T.C. , Stijnen Theo , Wladimiroff Juriy W.
Published: December 2003

Objectives
To determine fetal liver volume and its relation with umbilical venous volume flow and maternal glycosylated haemoglobin (HbA1c) in pregnancies complicated by diabetes mellitus type I.

Design
A cross sectional matched control study.

Setting
Obstetric out patient clinic, Erasmus MC—University Medical Centre, Rotterdam.

Population
Data from fetuses of diabetic women (n = 32; 18–36 weeks) were compared with data from normal controls (n = 32) matched for gestational age.

Methods
Umbilical venous cross sectional area (mm2) and time‐averaged velocity (mm/s Doppler) were determined for calculation of volume flow (mL/min) and flow per kilogram fetal weight (mL/min/kg). Umbilical artery pulsatility index was determined. Fetal liver volume measurements were obtained using a Voluson 530‐D.

Main outcome measures
Fetal liver volume, umbilical venous volume flow and downstream impedance.

Results
A statistically significant difference between fetuses of diabetic women and normal controls was found for liver volume (mean [SD]: 45.9 [34.0] vs 38.3 [28.7] mL), abdominal circumference (22.2 [6.6] vs 21.3 [5.6] cm), estimated fetal weight (1162 [898] vs 1049 [765] g) and fetoplacental weight ratio (0.22 vs 0.19) and liver volume/estimated fetal weight ratio (4.13% [0.007] vs 3.62% [0.009]). Umbilical venous volume flow (mL/min) and umbilical artery pulsatility index were not essentially different between the two study groups, but umbilical venous volume flow per kilogram fetal weight was lower (P < 0.05) in the diabetes group (94.3 [26.1] mL/min kg) compared with normal controls (109.5 [28.0] mL/min/kg). A positive correlation existed between fetal liver volume and maternal HbA1c (P = 0.002).

Conclusions
Measurement of fetal liver volume by three‐dimensional ultrasound may play a role in identifying fetal growth acceleration in diabetic pregnancies. Fetal liver volume increase is positively related to maternal HbA1c levels reflecting degree of maternal glycemic control. Fetal liver volume normalised for estimated fetal weight is significantly higher in the fetuses of diabetic women. In the present study, umbilical venous volume flow and fetoplacental downstream impedance are not different between diabetic and normal pregnancies.
Assessment of a structured in‐hospital educational intervention addressing breastfeeding: a prospective randomised open trial
Authors: Labarere Jose , Bellin Valerie , Fourny Magali , Gagnaire Jean‐Claude , Francois Patrice , Pons Jean‐Claude
Published: December 2003

Objective
To determine whether a single one‐to‐one in‐hospital education session could increase the rate of breastfeeding at 17 weeks.

Design
A prospective, randomised, parallel group, open trial.

Setting
A level two maternity hospital in France.

Sample
Breastfeeding mothers who were employed outside the home prenatally and were delivered of a healthy singleton.

Intervention
A structured one‐to‐one in‐hospital education session.

Methods
One hundred and six mother–infant pairs were allocated to the intervention group and 104 to the control group (receiving usual verbal encouragement). A total of 93 mother–infant pairs in the intervention group and 97 in the control group provided complete data for final evaluation of efficacy.

Main outcome measure
Rate of breastfeeding at infant age of 17 weeks.

Results
There was no significant difference between the two groups in the rate of any breastfeeding (34.4% in the intervention group vs 40.2% in the control group, relative risk = 0.86 [0.52–1.40]), and in the rate of exclusive breastfeeding (14.0% in the intervention group vs 14.4% in the control group, relative risk = 0.97 [0.42–2.22]).

Conclusion
Our findings suggest that a single in‐hospital educational intervention has no effect on the breastfeeding rate at four months. Guidance provided by maternity staff should be reinforced by a long term multifaceted support programme in countries with a low to intermediate rate of breastfeeding.
Maternal mortality: only 42 days?
Authors: Høj Lars , da Silva Domingos , Hedegaard Kathryn , Sandström Anita , Aaby Peter
Published: December 2003

Objective
A maternal death is defined by WHO as ‘the death of a woman while pregnant or within 42 days of termination of pregnancy…’. The origin of the 42 days is no longer clear. In developing countries, the burden imposed by pregnancy and birth on a woman's body may extend beyond 42 days as pregnancy‐related anaemia can persist for longer and vaginal haemorrhaging and risk of infections are not necessarily over after six weeks. We therefore examined duration of excess mortality after delivery in rural Guinea‐Bissau.

Design
In a prospective cohort study, we followed 15,844 women of childbearing age with biannual visits over a period of six years, resulting in a total of 60,192 person‐years‐at‐risk. To establish cause and timing in relation to termination of pregnancy, verbal autopsy was carried out for all deaths. Mortality rates were calculated for short time intervals after each delivery or miscarriage.

Results
During the observation period we registered 14,257 pregnancies and 350 deaths. One hundred and ninety‐four deaths followed termination of a registered pregnancy and thus were eligible for the analysis. Eighty‐two deaths occurred during the first 42 days after delivery/miscarriage. A further 16 women died in the period from 43 to 91 days after parturition, 16 between 92 and 182 days and 18 between 183 and 365 days after delivery. Compared with baseline mortality 7–12 months after delivery, women who had recently delivered had 15.9 times higher mortality (95% CI 9.8–27.4). From days 43 to 91 the mortality was still significantly elevated (RR = 2.8 [1.4–5.4]).

Conclusion
Where living conditions are harsh, pregnancy and delivery affect the health of the woman for more than 42 days. Using the WHO definition may result in an under‐estimation of the pregnancy‐related part of the reproductive age mortality. Extending the definition of maternal death to include all deaths within three months of delivery may increase current estimates of maternal mortality by 10–15%.
Predicting residual disease after excision of cervical dysplasia
Authors: Johnson Nicholas , Khalili Mansoureh , Hirschowitz Lynn , Ralli Fran , Porter Richard
Published: December 2003

Dysplastic epithelium at the resection margin after a cervical cone is known to predict persisting disease. We followed 702 women for 30 months after cervical excision to see which resection margin was predictive. The risk of persisting cytological abnormalities was doubled when CIN extended to the endocervical resection margin and was doubled when there was evidence of HPV. In contrast, disease at the ectocervical resection margin and the grade of CIN were not associated with a higher risk of residual disease.
Was Breast Conserving Surgery Underutilized for Early Stage Breast Cancer? Instrumental Variables Evidence for Stage II Patients from Iowa
Authors: Brooks John M. , Chrischilles Elizabeth A. , Scott Shane D. , Chen‐Hardee Shari S.
Published: December 2003

Objective. To estimate the average survival effects of breast conserving surgery plus irradiation relative to mastectomy for marginal stage II breast cancer patients in Iowa from 1989–1994.

Data Sources/Data Setting. Secondary linked Iowa SEER Cancer Registry—Iowa Hospital Association discharge abstract data for women in Iowa with stage II breast cancer from 1989–1994.

Study Design. Observational instrumental variables (IV) analysis.

Data Collection/Extraction Methods. Women with stage II breast cancer from the Iowa SEER Cancer Registry 1989–1994 who received all of their inpatient care in Iowa were linked with their respective hospital discharge abstracts.

Principal Findings. Breast conserving surgery plus irradiation decreased survival relative to mastectomy for marginal stage II breast cancer patients in Iowa during the early 1990s. In this study marginal patients were those whose surgery choices were affected by differences in area treatment rates and access to radiation facilities.

Conclusions. If marginal patients are representative of patients whose treatment choices would be affected by changes in treatment rates, an increase in the breast conserving surgery plus irradiation rate for stage II early stage breast cancer patients would have decreased survival in Iowa during the early 1990s. Further research with newer data and broader samples is needed to make more current and specific assessments.