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Comparison of two combined methods for second-trimester pregnancy termination using misoprostol with Foley traction or saline infusion

Comparative efficacy of two combined mechanical–pharmacological methods for second-trimester pregnancy termination: A randomized clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250604066064N1
Enrollment
106
Registered
2025-06-09
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Second trimester pregnancy termination

Interventions

Intervention 1: Intervention group: Participants will receive 400 micrograms of misoprostol sublingually every 3 hours combined with insertion of a size 24 Foley catheter inflated with 30 ml of normal

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Pregnant women between 13 and 24 weeks of gestation Age between 18 and 50 years Willingness and ability to provide informed consent

Exclusion criteria

Exclusion criteria: Known allergy or hypersensitivity to misoprostol Presence of placenta accreta or percreta Suspected or confirmed septic abortion Clinical diagnosis of chorioamnionitis

Design outcomes

Primary

MeasureTime frame
Time to complete abortion. Timepoint: Continuously measured during the intervention; final assessment within 24 hours post-intervention. Method of measurement: Recorded by medical staff from the start of the intervention until complete expulsion of fetal and placental tissue.;Abortion success rate. Timepoint: Final assessment within 24 hours post-intervention. Method of measurement: Confirmed by ultrasound examination.;Duration of uterine bleeding. Timepoint: Monitored up to 48 hours post-intervention. Method of measurement: Assessed via patient self-reporting and clinical observation.;Incidence of adverse effects. Timepoint: Evaluated up to 48 hours post-intervention. Method of measurement: Evaluated through clinical examination and patient interviews.

Secondary

MeasureTime frame
Duration of uterine bleeding. Timepoint: Baseline (before intervention), immediately after abortion, and up to two weeks post-intervention. Method of measurement: Recorded using patient bleeding diary and clinical observation.;Amount of bleeding. Timepoint: Baseline, immediately after abortion, and up to two weeks post-intervention. Method of measurement: Estimated by medical staff.;Patient satisfaction. Timepoint: Baseline, immediately after abortion, and up to two weeks post-intervention. Method of measurement: Assessed using a standardized questionnaire.;Incidence of adverse effects. Timepoint: Baseline, immediately after abortion, and up to two weeks post-intervention. Method of measurement: Documented through clinical examination and patient interviews.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Maryam Mazloomi

Iran University of Medical Sciences

dr.m.mazloomi@gmail.com+98 21 86701

Outcome results

None listed

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