Misoprostol for Induction of Labor in Obese Women: Comparison Between 25 and 50 mcg Oral Administration - a Randomized Trial

CHUC-151-17

In recent decades, obesity has become a prevalent issue in Portugal, with 38.6% and 13.8% of the population being overweight or obese, respectively. Obese pregnant women have a higher rate of obstetric complications, including hypertensive complications, gestational diabetes and fetal macrosomia, leading to increased induction of labor (IOL) and cesarean section (CS) rates. To determine the effect of increasing oral misoprostol dose on CS rate in obese pregnant women undergoing IOL, a randomized controlled trial with a sample size of 114 cases in each group was calculated to detect a 15% difference in CS rate. The primary objective is to determine the effect of increasing oral misoprostol dose, with secondary goals being to compare successful IOL rates and their relationship with oral misoprostol dose, as well as to evaluate tolerability and side effects in relation to different doses of oral misoprostol.

2019-10-15

2024-05-31

2024-06-30

Recruiting

228

Inclusion Criteria: * BMI ≥ 30 kg/m2 recorded based on maternal weight at preconception or in the first trimester * Singleton live gestation with vertex presentation * Pregnancies followed in our institution with sonographic confirmation of gestational age in the first trimester * Obstetrical indication for labor induction * Bishop score of \<5 at the time of induction of labor Exclusion Criteria: * Underweight and normal weight women (BMI \<30 kg/m2) * Known hypersensitivity to prostaglandins * Preterm gestations (\< 37 weeks) * Multiple gestation * Women who cannot give their informed consent * Contraindications for vaginal delivery * Previous c-section or uterine scar due to previous gynecological surgery * Maternal or fetal pathology (for example: fetal indications: non-reassuring fetal status - intra-uterine growth restriction with abnormal umbilical doppler, abnormal fetal cardiac rhythm; stillbirth; or maternal/pregnancy related indications such as placenta previa)

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pregnant women seen at the obstetric clinic of Maternidade Daniel de Matos, with a first trimester ultrasound pregnancy dating at our institution; with a maternal BMI measurement in the first trimester ≥ 30 kg/m2 and with a maternal or obstetric indication for IOL, who agreed to participate in the study. They will be randomized into two groups: one will consist of pregnant women undergoing the basic IOL protocol of Maternidade Daniel de Matos (oral misoprostol 25µcg every 2 hours); the other will be submitted to a 50µcg dosage every 2 hours, maximum of 7 doses per day (maximum 2 days). The pregnant woman will have a choice of an envelope, which will be her group assignment and will be coded until the end of the trial.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 228, 'type': 'ESTIMATED'}}

2023-10-24