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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 15
Maximum Age: 55
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Portugal
Iolanda João Mora Cruz de Freitas Ferreira
RECRUITING
Coimbra
Contact Information
Primary
Iolanda Ferreira
10862@chuc.min-saude.pt
+351 239 403 060
Time Frame
Start Date: 2019-10-15
Estimated Completion Date: 2024-06-30
Participants
Target number of participants: 228
Treatments
Active_comparator: Misoprostol 25 mcg
Participants received misoprostol 25 mcg every 2 hours until the active stage of labour was attained or failed induction was diagnosed
Experimental: Misoprostol 50 mcg
Participants received misoprostol 25 mcg matching misoprostol 50 mcg every 2 hours until the active stage of labour was attained or failed induction was diagnosed
Related Therapeutic Areas
Sponsors
Leads: Unidade Local de Saúde de Coimbra, EPE

This content was sourced from clinicaltrials.gov