Misoprostol versus watchful waiting for retained tissue after first-trimester medical abortion
The Success Rate After Expectant & Medical Management for a Retained Product of Conception After Medical Termination of Pregnancy in First Trimester Spontaneous Abortion-RCT
This project will test whether taking misoprostol or simply watching and waiting works better to clear retained tissue after a first‑trimester medical abortion in women aged 18–45 with ultrasound evidence of retained products.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Meir Medical Center Academic / other |
| Locations | 1 site (Kfar Saba) |
| Trial ID | NCT07534982 on ClinicalTrials.gov |
What this trial studies
This is a prospective randomized controlled trial that assigns 150 women with sonographic evidence of retained products of conception (RPOC) after first‑trimester medical abortion to either medical management with misoprostol or expectant (watchful waiting) management. Eligible participants are hemodynamically stable women aged 18–45 with endometrial thickness >10 mm and Doppler flow into the uterine cavity. Participants will attend three follow‑up visits over six weeks with ultrasound monitoring to document uterine clearance and record complications. Primary outcomes include radiographic resolution of RPOC and need for surgical intervention, with secondary safety and complication endpoints.
Who should consider this trial
Good fit: Women aged 18–45 who are hemodynamically stable after a first‑trimester medical abortion, have sonographic RPOC defined as endometrial thickness >10 mm with Doppler flow, bleeding similar to a menstrual period, and no fever.
Not a fit: Women with heavy bleeding, fever, hemodynamic instability, endometrial thickness >40 mm, a retained gestational sac, or who have already received two doses of misoprostol are excluded and unlikely to benefit from these non‑surgical options.
Why it matters
Potential benefit: If successful, this approach could reduce the need for surgical removal and offer a safe non‑surgical option for many women with RPOC.
How similar studies have performed: Previous studies and clinical experience show misoprostol can resolve RPOC in many patients and expectant management succeeds for some, but randomized comparisons are limited and results have varied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18-45. 2. RPOC identified on ultrasound after medical abortion, defined as endometrial thickness \>10 mm with Doppler flow into the uterine cavity. 3. Hemodynamically stable women with bleeding comparable to menstrual flow, without fever. Exclusion Criteria: 1. Hemodynamic instability, excessive bleeding, or fever. 2. Endometrial thickness \>40 mm. 3. Endometrial thickness \<10 mm without Doppler flow into the cavity. 4. Presence of a gestational sac within the uterine cavity. 5. Women who received two doses of misoprostol before evaluation.
Where this trial is running
Kfar Saba
- Meir Medical Center — Kfar Saba, Israel (Recruiting)
Study contacts
- Study coordinator: Chen Manor Bar, MD
- Email: Manor.chen@gmail.com
- Phone: +972544414211
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.