Success Rates of Expectant vs. Medical Management for Retained Products After First-Trimester Abortion: Randomized Controlled Trial
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 prospective randomized controlled trial evaluates the success of medical versus expectant management for retained products of conception (RPOC) following medical abortion with mifepristone and misoprostol for delayed miscarriage in the first trimester. Women aged 18-45 with sonographic evidence of RPOC (endometrial thickness >10 mm with Doppler flow) will be randomized into two groups: medical management with misoprostol or expectant management (observation only). Follow-up will include ultrasound evaluations over six weeks to monitor uterine clearance and determine further interventions.
Population: 150 participants, with 75 in each group. Inclusion Criteria: Stable women with RPOC after medical abortion, bleeding comparable to menstrual flow, and no fever.
Exclusion Criteria: Hemodynamic instability, excessive bleeding, fever, or specific endometrial thickness criteria.
Outcome Measures: RPOC resolution, need for surgical intervention, complications, and sonographic changes.
Study Duration: Five years. Data on demographics, medical history, and ultrasound findings will be analyzed using SPSS, with results informing optimal management strategies for RPOC after first-trimester medical abortion.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Goals:
- Primary Objectives: Evaluate the effectiveness of medical management with misoprostol and expectant management for retained products of conception (RPOC) following medical abortion for delayed miscarriage in the first trimester (up to 12 weeks).
- Secondary Objectives: Assess the safety and complications of expectant versus medical management of RPOC.
Study Design:
- Prospective study involving women diagnosed with RPOC following medical abortion with mifepristone and misoprostol for delayed miscarriage in the first trimester.
- Participants will be randomized into two groups: medical management with misoprostol and expectant management (observation only).
- Data will be collected through three follow-up visits over six weeks, with ultrasound evaluations to monitor uterine content and decide on further interventions, if necessary.
Population:
Women aged 18-45 diagnosed with delayed miscarriage up to 12 weeks gestation, with sonographic evidence of RPOC after medical abortion using mifepristone and misoprostol.
Inclusion Criteria:
- Age 18-45.
- RPOC identified on ultrasound after medical abortion, defined as endometrial thickness >10 mm with Doppler flow into the uterine cavity.
- Hemodynamically stable women with bleeding comparable to menstrual flow, without fever.
Exclusion Criteria:
- Hemodynamic instability, excessive bleeding, or fever.
- Endometrial thickness >40 mm.
- Endometrial thickness <10 mm without Doppler flow into the cavity.
- Presence of a gestational sac within the uterine cavity.
- Women who received two doses of misoprostol before evaluation. Study Duration:Five years.
Sample Size:
Based on previous studies, 124 women (62 per group) are required for 80% power at a 5% significance level. Accounting for potential attrition, a total of 150 participants will be recruited (75 in each group).
Data Collection:
- Demographic data (age, ethnicity, weight, height).
- Medical history (chronic conditions, medications).
- Obstetric and gynecologic history.
- Current pregnancy details (gestational age, method of conception).
- Sonographic data at diagnosis and follow-ups (endometrial thickness, RPOC dimensions, Doppler flow parameters).
- Complications during the process (surgical interventions, blood transfusions, infections, intrauterine adhesions).
Statistical Analysis:
Data will be analyzed using SPSS software. ANOVA will assess differences between groups on outcomes.
Confidentiality:
All data will be anonymized and stored securely, with access limited to the primary and co-investigators. Data will be retained for 15 years.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chen Manor Bar, MD
- Phone Number: +972544414211
- Email: manor.chen@gmail.com
Study Locations
-
-
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Kfar Saba, Israel, 4861027
- Recruiting
- Meir Medical Center
-
Contact:
- Chen Manor Bar, MD
- Phone Number: +972544414211
- Email: manor.chen@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18-45.
- RPOC identified on ultrasound after medical abortion, defined as endometrial thickness >10 mm with Doppler flow into the uterine cavity.
- Hemodynamically stable women with bleeding comparable to menstrual flow, without fever.
Exclusion Criteria:
- Hemodynamic instability, excessive bleeding, or fever.
- Endometrial thickness >40 mm.
- Endometrial thickness <10 mm without Doppler flow into the cavity.
- Presence of a gestational sac within the uterine cavity.
- Women who received two doses of misoprostol before evaluation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: • Participants will be randomized into two groups: medical management with misoprostol and expectant
expectant management (observation only).
|
|
|
Experimental: medical management
medical management with misoprostol
|
Following the diagnosis of RPOC after a missed abortion managed with a medical abortion protocol, medical management will involve administering 800 mg of misoprostol as per our departmental guidelines.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluate effectiveness of medical management
Time Frame: From the time of enrollment until the completion of follow-up for the first trimester abortion- up to 12 weeks.
|
Evaluate the effectiveness of medical management with misoprostol and expectant management for retained products of conception (RPOC) following medical abortion for delayed miscarriage in the first trimester (up to 12 weeks).
|
From the time of enrollment until the completion of follow-up for the first trimester abortion- up to 12 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess the complication of expectant versus medical management of RPOC.
Time Frame: From the time of enrollment until the completion of follow-up for the first trimester abortion- up to 12 weeks
|
infection, uterine adhesions
|
From the time of enrollment until the completion of follow-up for the first trimester abortion- up to 12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0056-24MMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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