A randomised controlled double-blind clinical trial of 17-hydroxyprogesterone caproate for the prevention of preterm birth in twin gestation (PROGESTWIN): evidence for reduced neonatal morbidity.

OBJECTIVE: To determine whether 17 alpha-hydroxyprogesterone caproate (17OHPC) prolongs gestation beyond 37 weeks of gestation (primary outcome) and reduces neonatal morbidity (secondary outcome) in twin pregnancy. DESIGN: Randomised controlled double-blind clinical trial. SETTING: Tertiary-care university medical centre. POPULATION: Unselected women with twin pregnancies. METHODS: Participants received weekly injections of 250 mg 17OHPC (n = 194) or placebo (n = 94), from 16-20 to 36 weeks of gestation. Randomisation was performed using the permuted-block randomisation method. Data were analysed on an intention-to-treat basis. MAIN OUTCOME MEASURE: Preterm birth (PTB) rate before 37 weeks of gestation. RESULTS: There were no significant differences in the average gestational age at delivery, or in the rates of PTB before 37, 32, and 28 weeks of gestation, between the two groups. The proportion of very-low-birthweight neonates (<1500 g) was significantly lower in the 17OHPC group (7.6%) compared with placebo (14.3%) (relative risk, RR 0.5; 95% confidence interval, 95% CI 0.3-0.9; P = 0.01). Progestogen-treated neonates had a significantly lower composite neonatal morbidity (19.1%) compared with placebo (30.9%) (odds ratio, OR 0.53; 95% CI 0.31-0.90; P = 0.02), with significantly lower odds for respiratory distress syndrome (14.4 versus 23.4%; OR 0.55; 95% CI 0.31-0.98; P = 0.04), retinopathy of prematurity (1.1 versus 4.6%; OR 0.21; 95% CI 0.05-0.96; P = 0.04), and culture-confirmed sepsis (3.4 versus 12.8%; OR 0.24; 95% CI 0.10-0.57; P = 0.00). CONCLUSIONS: Intramuscular 17OHPC therapy did not reduce PTB before 37 weeks of gestation in unselected twin pregnancies. Nonetheless, 17OHPC significantly reduced neonatal morbidity parameters and increased birthweight.

Effectiveness of progestogens to improve perinatal outcome in twin pregnancies: an individual participant data meta-analysis.

BACKGROUND: In twin pregnancies, the rates of adverse perinatal outcome and subsequent long-term morbidity are substantial, and mainly result from preterm birth (PTB). OBJECTIVES: To assess the effectiveness of progestogen treatment in the prevention of neonatal morbidity or PTB in twin pregnancies using individual participant data meta-analysis (IPDMA). SEARCH STRATEGY: We searched international scientific databases, trial registration websites, and references of identified articles. SELECTION CRITERIA: Randomised clinical trials (RCTs) of 17-hydroxyprogesterone caproate (17Pc) or vaginally administered natural progesterone, compared with placebo or no treatment. DATA COLLECTION AND ANALYSIS: Investigators of identified RCTs were asked to share their IPD. The primary outcome was a composite of perinatal mortality and severe neonatal morbidity. Prespecified subgroup analyses were performed for chorionicity, cervical length, and prior spontaneous PTB. MAIN RESULTS: Thirteen trials included 3768 women and their 7536 babies. Neither 17Pc nor vaginal progesterone reduced the incidence of adverse perinatal outcome (17Pc relative risk, RR 1.1; 95% confidence interval, 95% CI 0.97-1.4, vaginal progesterone RR 0.97; 95% CI 0.77-1.2). In a subgroup of women with a cervical length of ≤25 mm, vaginal progesterone reduced adverse perinatal outcome when cervical length was measured at randomisation (15/56 versus 22/60; RR 0.57; 95% CI 0.47-0.70) or before 24 weeks of gestation (14/52 versus 21/56; RR 0.56; 95% CI 0.42-0.75). AUTHOR'S CONCLUSIONS: In unselected women with an uncomplicated twin gestation, treatment with progestogens (intramuscular 17Pc or vaginal natural progesterone) does not improve perinatal outcome. Vaginal progesterone may be effective in the reduction of adverse perinatal outcome in women with a cervical length of ≤25 mm; however, further research is warranted to confirm this finding.

The effect of maternal fasting during Ramadan on preterm delivery: a prospective cohort study.

OBJECTIVE: To determine the effect of fasting during the month of Ramadan on the rate of preterm delivery (PTD). DESIGN: A prospective cohort study of women with singleton pregnancies who elected to fast and matched controls. SETTING: Four medical centres in Beirut, Lebanon. POPULATION: Women presenting for prenatal care (20-34 weeks of gestation) during the month of Ramadan, September 2008. METHODS: Data were collected prospectively. The frequency of PTD was evaluated in relation to the duration of fasting and the stage of gestation at the time of fasting. MAIN OUTCOME MEASURES: The primary endpoint was the percentage of pregnant women who had PTD, defined as delivery before 37 completed weeks of gestation. RESULTS: A total of 468 women were approached, of whom 402 were included in the study. There were no differences in smoking history and employment. There was no difference in the proportion of women who had PTD at <37 weeks (10.4% versus 10.4%) or PTD at <32 weeks (1.5% versus 0.5%) in the Ramadan-fasted group and the controls, respectively. The PTD rate was also similar in those who fasted before or during the third trimester. The mean birthweight was lower (3094 ± 467 g versus 3202 ± 473 g, P = 0.024) and the rate of ketosis and ketonuria was higher in the Ramadan-fasted women. On multivariate stepwise logistic regression analysis, fasting was not associated with an increased risk of PTD (odds ratio 0.72; 95% confidence interval 0.34-1.54; P = 0.397). The only factor that had a significant effect on the PTD rate was body mass index (odds ratio 0.43; 95% confidence interval 0.20-0.93; P = 0.033). CONCLUSIONS: Fasting during the month of Ramadan does not seem to increase the baseline risk of preterm delivery in pregnant women regardless of the gestational age during which this practice is observed.

Cocoa butter lotion for prevention of striae gravidarum: a double-blind, randomised and placebo-controlled trial.

OBJECTIVE: To assess whether application of cocoa butter lotion reduces the development of striae gravidarum (SG). DESIGN: Multicentre, double-blind, randomised and placebo-controlled trial. SETTING: Beirut and Tripoli, Lebanon. POPULATION: Nulliparous women presenting for prenatal care. METHODS: Nulliparous women presenting in the first trimester were randomly assigned to receive a lotion containing cocoa butter or a placebo lotion. Women were instructed to apply the assigned lotion daily until delivery. MAIN OUTCOME MEASURE: The development of striae over the abdomen, breasts and thighs postpartum. RESULTS: Of 210 women enrolled, 175 (83%) completed the study. Ninety-one women received the study lotion and 84 received the placebo. There was no difference in the development of SG (45.1% versus 48.8%; P = 0.730) or the severity of SG between cases and controls. The results did not change when presence of stretch marks at enrolment or compliance with the regimen were taken into account. CONCLUSION: Topical application of a lotion containing cocoa butter does not appear to reduce the likelihood of developing striae gravidarum.

A randomised comparison of patient satisfaction with vaginal and sublingual misoprostol for induction of labour at term.

OBJECTIVE: To compare patient satisfaction with two routes of misoprostol for term labour induction. DESIGN: Prospective randomised trial. SETTING: Tertiary care hospital. POPULATION: A total of 170 women admitted at > or = 37 weeks of gestation for induction of labour. METHODS: Women were randomised to receive 50 micrograms of either sublingual or vaginal misoprostol. MAIN OUTCOME MEASURES: Patient satisfaction with the route of administration. RESULTS: Despite a similar proportion reporting the labour induction as more painful than expected in both groups, a significantly lower proportion mentioned that the pelvic examinations were very painful in the sublingual group (19.7 versus 36.1%, relative risk [RR] 0.5, 95% CI 0.3-0.9). Request for analgesia was similar in both groups. More women in the sublingual group thought that the labour experience was better than expected (RR 2.0, 95% CI 1.2-3.3), had a positive attitude towards induction in subsequent pregnancies (RR 1.6, 95% CI 1.1-2.3) and preferred the same route in subsequent pregnancies (RR 3.1, 95% CI 2.2-4.5). Mean number of misoprostol doses, oxytocin augmentation, tachysystole and hyperstimulation, induction to vaginal delivery interval, vaginal delivery after a single dose, vaginal birth within 12 and 24 hours, and caesarean delivery rates were similar in both groups. CONCLUSION: Sublingual misoprostol (50 micrograms) is associated with a significantly higher patient satisfaction rate compared with a similar dose of vaginal misoprostol. Sublingual administration offers additional choice to women, in particular those wishing to avoid vaginal administration.

Mode of delivery for vertex-nonvertex twin gestations.

OBJECTIVE: To compare the neonatal outcome of vaginally delivered (VD) to that of abdominally delivered (CS) vertex-nonvertex (Vx/NVx) twins. METHODS: Vx/NVx live nonanomalous twin gestations >or=25 weeks delivered from 1984 to 2000 were divided into two groups: VD (N=138), and CS (N=79). The outcome of the second twin was compared. RESULTS: The vaginal delivery rate for the Vx/NVx twins was 63.6%. The median Apgar scores at 1 and 5 min, respectively, were significantly lower in VD [7 (0-9) and 9 (1-10)] compared to CS [8 (2-10) and 9 (2-10)]. The neonatal mortality was also higher in VD (109/1000 vs. 38/1000, p=0.040). Differences in the 1-min Apgar scores persisted when infants <1500 g were excluded. All other neonatal outcome variables studied including respiratory distress syndrome, necrotizing enterocolitis, intraventricular hemorrhage, trauma, seizures, and length of nursery stay were similar. On logistic regression analysis, vaginal delivery of Vx/NVx twins marginally increased low 5-min Apgar scores and neonatal deaths. CONCLUSION: Vaginal delivery in vertex-nonvertex twins was achieved in 63.6% of cases at the expense of a higher incidence of low 1- and 5-min Apgar scores and neonatal death.

Risk factors for meconium aspiration syndrome.

OBJECTIVE: To identify potential predictors of meconium aspiration syndrome (MAS) in pregnancies complicated by moderate or thick meconium-stained amniotic fluid (AF). METHODS: In the period 1990-1993, 937 vertex singleton pregnancies with moderate or thick meconium-stained AF were delivered; of these, 39 neonates developed MAS and 898 did not. The two groups were compared retrospectively according to maternal findings, pregnancy outcome, and neonatal complications, using univariate analysis (P < .05 considered significant) and stepwise multiple logistic regression analysis to identify independent significant factors for prediction of MAS and to calculate odds ratios (OR) and 95% confidence intervals. RESULTS: The two groups had a similar mean gestational age at delivery and birth weight. They also had similar incidences of post-dates pregnancies, small and large for gestational age infants, and amnioinfusion use. Univariate analysis identified significant differences between the two groups in 13 variables, two of which were excluded from logistic analysis because of inadequate data. Logistic regression analysis identified only six variables with independent, statistically significant effects on MAS: admission for induction with nonreassuring fetal heart tracing (OR 6.9), need for endotracheal intubation and suctioning below the vocal cords (OR 4.9), 1-minute Apgar score of 4 or less (OR 3.1), present cesarean delivery (OR 3.0), and previous cesarean delivery (OR 2.5). Cigarette smoking was associated with a lower risk for MAS (OR 0.07). The presence of at least one of the five risk factors had a sensitivity of 92%, a specificity of 56%, a positive predictive value of 8%, and a negative predictive value of 99% for MAS. CONCLUSION: Considering the high negative predictive value of the test, infants without any risk factors will not develop MAS and thus can be safely allowed to room with their mothers. Furthermore, this model helps to identify infants who may benefit from 24-hour observation and in counseling women about the neonatal risk for developing MAS.

The impact of a policy of amnioinfusion for meconium-stained amniotic fluid.

OBJECTIVE: To evaluate the impact of an amnioinfusion (AI) policy for thick or moderate meconium-stained amniotic fluid (AF) on neonatal outcome, specifically meconium-aspiration syndrome and its complications. METHODS: We reviewed maternal and neonatal charts of 937 vertex, singleton pregnancies complicated by moderate or thick meconium-stained AF during a 3-year period. The patients were divided into groups according to whether AI was performed. Demographic characteristics, risk factors, mode of delivery, pregnancy outcome, and neonatal complications, including meconium-aspiration syndrome, were analyzed. RESULTS: Four hundred forty patients (47%) received AI (AI group); 497 (53%) did not, for the following reasons: imminent delivery (310 patients), occult meconium (141), or emergency cesarean delivery (46) (no-AI group). Our study did not show any reduction in the incidence of 5-minute Apgar scores of 7 or less (8 versus 7%), meconium below the vocal cords (28 versus 29%), meconium aspiration syndrome (4.5 versus 3.8%), ventilation requirement (4.3 versus 2.4%), or neonatal death (0.7 versus 0.2%) in the AI and no-AI groups, respectively. The AI group had a higher incidence of fetal heart rate abnormalities in labor (48 versus 31%, P < .05), instrumental delivery (15 versus 8%, P < .05), cesarean delivery (28 versus 17%, P < .001), and endometritis (21 versus 13%, P = .004). CONCLUSIONS: With the policy of routine AI for moderate or thick meconium-stained AF, AI was not clinically feasible in 53% of the cases. We were unable to demonstrate any improvement in neonatal outcome in those who received AI for moderate or thick meconium.

Imperforate hymen: report of an unusual familial occurrence.

BACKGROUND: Although imperforate hymen occurs in approximately 0.1% of female newborns, familial occurrence of imperforate hymen has been reported only once. CASES: We report two families in which imperforate hymen was diagnosed in three siblings of each family. One family is described in detail; the patients were two postmenarchal young women and one premenarchal girl. CONCLUSION: Imperforate hymen usually occurs sporadically but can be familial. We advise screening all female newborns and children for vaginal patency, especially family members of an affected child. Identification of other families with a similar problem might point to a specific mode of inheritance.

Emergent management of puerperal eclampsia.

Eclampsia is a life-threatening emergency that continues to be a major cause of serious maternal morbidity and is still the leading cause of maternal mortality worldwide. Complicated and mismanaged cases are responsible for many maternal deaths. Perinatal morbidity and mortality is also high if eclampsia occurs in the antepartum period. This article reviews eclampsia management with special emphasis on puerperal eclampsia. The complications associated with eclampsia are also discussed.

The conventional doses of human chorionic gonadotropins may not always be sufficient to induce ovulation in all women: a reappraisal.

BACKGROUND: Failure of ovulation has occasionally been reported following the administration of conventionally recommended doses of exogenous human chorionic gonadotropins. CASE: A 25-year-old nulliparous woman with polycystic ovary syndrome underwent ovulation induction for primary infertility. Following successful ovarian stimulation, she failed to ovulate during two consecutive cycles in response to human chorionic gonadotropin doses of 5,000 and 10,000 IU. When challenged with a higher than conventional dose (15,000 IU) on the third cycle, she ovulated and conceived. CONCLUSION: Conventional doses of exogenous human chorionic gonadotropins occasionally fail to complete the ovulatory process in some women. Women with polycystic ovary syndrome appear to be particularly susceptible. Routine documentation of ovulation and individualization of the dose of exogenous human chorionic gonadotropins could therefore prove to be useful in some of these women in order to achieve the best treatment outcome.