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

NCT05857059 | Unknown

• 1 other identifier: CHUC-151-17
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Labor, Induced; Obesity; Pregnancy; Cesarean Section

Outcome Measures

Primary Outcomes (2)

• Cesarean section rates

  Calculation in percentage. An average of 22% cesarean section rate in non-obese pregnant women undergoing IOL was determined, with a between-groups difference of 15% on cesarean section rates being considered clinically significant.

  Up to 3 days after first misoprostol intake until delivery (vaginal or cesarean section)

• Indication for cesarean section

  The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine guidelines for caesarean section indications are used. When a caesarean section is performed, it will be classified in mutually exclusive categories. These are: First stage labor dystocia: Yes/No Second stage labor dystocia: Yes/No Abnormal or indeterminate fetal heart rate tracing: Yes/No Failed induction: Yes/No

  Delivery

Secondary Outcomes (5)

• Rate of vaginal delivery within 24 hours

  Time of first misoprostol intake until vaginal delivery

• Time interval from the first dose of misoprostol to vaginal delivery

  Time of first misoprostol intake until vaginal delivery

• Rate of instrumental delivery

  Delivery

• Time interval from the first dose of misoprostol to cesarean section delivery

  Time of first misoprostol intake until cesarean section delivery

• Incidence of misoprostol adverse effects

  Time of first misoprostol intake until vaginal or cesarean section delivery

Study Arms (2)

Misoprostol 25 mcg

ACTIVE COMPARATOR

Participants received misoprostol 25 mcg every 2 hours until the active stage of labour was attained or failed induction was diagnosed

Drug: Misoprostol 25 mcg

Misoprostol 50 mcg

EXPERIMENTAL

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

Drug: Misoprostol 50 mcg

Interventions

Misoprostol 25 mcg DRUG

Misoprostol 50 mcg every 2 hours

Misoprostol 25 mcg

Misoprostol 50 mcg DRUG

Misoprostol 50 mcg every 2 hours

Misoprostol 50 mcg

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Unidade Local de Saúde de Coimbra, EPE: lead

Study Sites (1)

Iolanda João Mora Cruz de Freitas Ferreira

Coimbra, 3000-157, Portugal

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Central Study Contacts

Iolanda Ferreira

CONTACT

+351 239 403 060; 10862@chuc.min-saude.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistente Hospitalar

Model Details: 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.

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: May 12, 2023
• Study Start: October 15, 2019
• Primary Completion: May 31, 2024
• Study Completion: June 30, 2024
• Last Updated: October 24, 2023

Record last verified: 2023-10

Locations

PT (1)