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Objective To determine whether 17 alpha-hydroxyprogesterone caproate (17 OHPC) 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 17 OHPC ( 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 17 OHPC 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 17 OHPC therapy did not reduce PTB before 37 weeks of gestation in unselected twin pregnancies. Nonetheless, 17 OHPC significantly reduced neonatal morbidity parameters and increased birthweight. [ABSTRACT FROM AUTHOR]

Please cite this paper as: Awwad J, Usta I, Succar J, Musallam K, Ghazeeri G, Nassar A. The effect of maternal fasting during Ramadan on preterm delivery: a prospective cohort study. BJOG 2012;119:1379-1386. 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. [ABSTRACT FROM AUTHOR]

OBJECTIVE: The aim of the study was to assess the rate of acceptance of preimplantation genetic diagnosis (PGD) as an alternative to prenatal diagnosis in Lebanese women with previously affected children with homozygous beta-thalassemia. METHODS: Women with a previously affected child attending a nongovernmentally funded thalassemia care center between 1 June 2005 and 31 May 2007 were offered a genetic counseling session. This was followed by administering a questionnaire through direct interview. RESULTS: All 97 women approached accepted to participate in the study (100% response rate). Sixty eight per cent of women considered PGD a better alternative to prenatal diagnosis. The most important perceived advantage of PGD was the avoidance of termination of an affected pregnancy. CONCLUSIONS: PGD is an acceptable alternative to conventional prenatal diagnosis in women at risk of conceiving a child affected with beta-thalassemia. This is particularly true in countries of the Middle-East where therapeutic abortions for fetal indications are prohibited by the law and religion. Copyright (c) 2008 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

A response from the author of the article "Design and statistical analysis of observational studies" in the November 20, 2012 issue is presented.

Objective: To estimate the magnitude of the correlation between neonatal outcomes of twins and demonstrate how this information can be used in the design of randomised controlled trials (RCTs) in women with twin pregnancies., Design: Secondary analysis of data from 12 RCTs., Setting: Obstetric care in multiple countries, 2004-2012., Population or Sample: 4504 twin pairs born to women who participated in RCTs to assess treatments given during pregnancy., Methods: Intraclass correlation coefficients (ICCs) were estimated using log-binomial and linear models., Main Outcome Measures: Perinatal death, respiratory distress syndrome, bronchopulmonary dysplasia, intraventricular haemorrhage, necrotising enterocolitis, sepsis, neonatal intensive care unit admission, birthweight, low birthweight and two composite measures of adverse neonatal outcome., Results: ICCs for the composite measures of adverse neonatal outcome were all above 0.5, indicating moderate to strong correlation between adverse outcomes of twins. For individual neonatal outcomes, median ICCs across trials ranged from 0.13 to 0.79 depending on the outcome. An example illustrates how ICCs can be used in sample size calculations for RCTs in women with twin pregnancies., Conclusions: The correlation between neonatal outcomes of twins varies considerably between outcomes and may be lower than expected. Our ICC estimates can be used for designing and analysing RCTs that recruit women with twin pregnancies and for performing meta-analyses that include such RCTs. Researchers are encouraged to report ICCs for neonatal outcomes in twins in their own RCTs., Tweetable Abstract: Correlation between neonatal outcomes of twins depends on the outcome and may be lower than expected., (© 2018 Royal College of Obstetricians and Gynaecologists.)

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., (© 2014 Royal College of Obstetricians and Gynaecologists.)

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., (© 2012 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2012 RCOG.)

Background: Obstetric drills are being used increasingly to test, improve, and maintain knowledge and skills related to obstetric emergencies as a means to improve proficiency and efficiency of practitioners. The purpose of this study was to assess the feasibility and usefulness of conducting drills to evaluate the response to obstetric emergencies using a holistic approach that tested the hospital system., Methods: A prospective trial was conducted at three hospitals (two tertiary referral centers and one small community hospital) in Beirut, Lebanon. Two different emergency obstetric drills at two points in time were conducted between April and May 2006 either in the emergency room or on the labor floor. The drills included medical and paramedical staff, a female actor (simulating a pregnant woman), a research assistant (acting as her companion), and a physician trained in obstetrics (the drill leader). Responses were recorded and critically analyzed., Results: Although overall quality of care was within standards of care, problems were identified related to hospital policies, supplies and equipment, communication, and clinical management. Some technical problems related to administration of the drills were identified. Most drill participants appreciated the exercise and found it beneficial., Conclusions: Obstetric drills provide a useful tool to identify and address deficiencies in the hospital system. This finding could have implications on improving quality of care provided to obstetric patients.

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.

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.

Little is known about the outcome of pregnancy in women with beta-thalassemia intermedia (TI). Over 10 years, maternal and neonatal outcomes of women with TI followed at a single thalassemia center were reviewed. Nine spontaneous pregnancies in five women with TI were studied. Six pregnancies resulted in live newborns; two were complicated by first-trimester abortions and one by an unexplained intrauterine fetal death at 36 weeks' gestation. Two patients had splenectomy before pregnancy: one required cesarean delivery and splenectomy at 31(2/7) weeks' gestation for worsening hemolytic anemia and thrombocytopenia and another had splenectomy 8 weeks postpartum for symptomatic hypersplenism. Two patients had received transfusions before pregnancy, and two required them for the first time during pregnancy and developed antibodies, which contributed to worsening of their anemia and repeated transfusions. The mean number of transfusions received during pregnancy was 8.0 +/- 5.2 units. The mean lowest hemoglobin level in pregnancy was 5.2 +/- 2.0 g/dl. Cesarean delivery was performed in 42.9% of cases. Mean gestational age at delivery was 36.7+/- 3.1 weeks with intrauterine growth restriction (IUGR) complicating 57.1% of cases. In conclusion, IUGR complicates more than half of pregnancies with TI. Transfusions are needed in most cases, even in non-transfusion-dependent patients. Postpartum splenectomy might be necessary in some patients.