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Effect of Misoprostol With or Without Methyl Ergometrine on First Trimester Medical Abortion

Effect of Misoprostol with or without Methyl Ergometrine on First Trimester Medical Abortion: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250818066905N1
Enrollment
324
Registered
2025-08-22
Start date
2025-09-21
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

The study focuses on first-trimester pregnancy termination. Medical abortion using Misoprostol alone or in combination with Methyl Ergometrine is commonly used to safely terminate early pregnancies and avoid surgical intervention.. Spontaneous abortion

Interventions

Intervention 1: Intervention group: Participants in the intervention group receive a single dose of 800 µg Misoprostol vaginally combined with 0.2 mg Methyl Ergometrine intramuscularly immediately aft

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Women aged 18 to 45 years Pregnancy = 12 weeks confirmed by ultrasound Eligible for medical abortion and willing to provide informed consent

Exclusion criteria

Exclusion criteria: Ectopic or molar pregnancy History of allergy to prostaglandins or ergot alkaloids Contraindications to misoprostol or methyl ergometrine (e.g., asthma, hypertension)

Design outcomes

Primary

MeasureTime frame
Rate of complete abortion (no need for surgical intervention). Timepoint: 24 hours, 7 days, and 14 days after intervention. Method of measurement: Assessed by transvaginal ultrasound and clinical evaluation.

Secondary

MeasureTime frame
Time to expulsion of pregnancy products. Timepoint: 24 hours, 7 days, and 14 days after intervention. Method of measurement: Recorded by clinical assessment and patient report.;Side effects including bleeding, nausea, vomiting, diarrhea, and abdominal pain. Timepoint: 24 hours, 7 days, and 14 days after intervention. Method of measurement: Assessed using standardized questionnaires and clinical evaluation.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mozhgan Mokhtari

Iran University of Medical Sciences

mokhtari.m@iums.ac.ir+98 21 5560 6034

Outcome results

None listed

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