Comparing two doses of misoprostol for inducing labor in obese women
Misoprostol for Induction of Labor in Obese Women: Comparison Between 25 and 50 mcg Oral Administration - a Randomized Trial
This study is testing whether different doses of misoprostol can help obese pregnant women have successful labor without needing a cesarean section.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 228 (estimated) |
| Ages | 15 Years to 55 Years |
| Sex | Female |
| Sponsor | Centro Hospitalar e Universitário de Coimbra, E.P.E. Academic / other |
| Locations | 1 site (Coimbra) |
| Trial ID | NCT05857059 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of two different oral doses of misoprostol (25 mcg and 50 mcg) on the rates of cesarean sections in obese pregnant women undergoing labor induction. The study aims to enroll 114 participants in each group to assess the impact of dosage on successful labor induction and the associated side effects. By focusing on obese women, the trial addresses a significant gap in understanding how obesity affects labor outcomes and the effectiveness of misoprostol as an induction agent. The findings could provide valuable insights into optimizing labor induction practices for this population.
Who should consider this trial
Good fit: Ideal candidates for this study are obese pregnant women with a BMI of 30 kg/m2 or higher who require labor induction.
Not a fit: Patients who are underweight or of normal weight, as well as those with contraindications for vaginal delivery, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved labor induction protocols for obese women, potentially reducing cesarean section rates and associated complications.
How similar studies have performed: While there is limited research specifically on misoprostol dosing in obese women, the study addresses a novel area with potential implications for improving labor induction outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Coimbra
- Iolanda João Mora Cruz de Freitas Ferreira — Coimbra, Portugal (Recruiting)
Study contacts
- Study coordinator: Iolanda Ferreira
- Email: 10862@chuc.min-saude.pt
- Phone: +351 239 403 060
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.