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Comparison of the Efficacy and Safety of Oral Misoprostol 100 µg versus 50 µg for Labor Induction in Term and Post-Term Pregnancies in Obese Women (BMI = 30): A Randomized Controlled Trial

Comparison of the effects and possible side effects of oral misoprostol 100 and 50 in patients with a body mass index above 30 for labor induction in term and post-term pregnancies

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250811066824N1
Enrollment
100
Registered
2025-09-04
Start date
2025-09-23
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Induction in Pregnant Women with Obesity (Body Mass Index BMI = 30).. Failure of induction of labor

Interventions

Intervention 1: Intervention group: Received misoprostol 50 micrograms vaginally.Method of administration: A 100-microgram misoprostol tablet is divided into two halves, and one half (50 micrograms) i

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Pregnancy Status: Pregnant women at 37 to 41 weeks of gestation (term and post-term pregnancy). Body Mass Index (BMI): Have a BMI greater than 30. Indication for Induction: Have a medical indication for induction of labor with misoprostol.Health Status: Be in good general health (as determined by medical history and clinical judgment). No Contraindications: Have no known contraindications to the use of misoprostol (e.g., no history of previous cesarean delivery or major uterine surgery in this context*).

Exclusion criteria

Exclusion criteria: Any medical or obstetric conditions that make the use of misoprostol dangerous (e.g., prior cesarean delivery, multiple gestation, placental problems, etc.). The patient’s unwillingness to participate in the study or to sign informed consent. Any known allergy or sensitivity to misoprostol.

Design outcomes

Primary

MeasureTime frame
The time interval, measured in hours, from the administration of the first dose of misoprostol to the complete birth of the baby. Timepoint: The exact time of the first dose administration and the time of birth will be meticulously recorded in the clinical reports. The difference between these two times will be calculated. Method of measurement: This variable is the most direct indicator for assessing the efficacy of the intervention (different doses of misoprostol). A shorter duration indicates a higher efficacy of the drug dose in accelerating the labor process.;The proportion of deliveries concluded vaginally without requiring surgical intervention (cesarean section) to the total number of deliveries in each group, reported as a percentage. Timepoint: The mode of delivery (vaginal or cesarean) will be recorded for each patient in the research dataset. Method of measurement: This outcome measures the ultimate goal of labor induction. A higher rate in one group indicates the superiority of that intervention in achieving a lower-risk, physiological birth.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSheida Sheli

Iran University of Medical Sciences

dr.sheyda.sheli@gmail.com+98 21 86701

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026