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| Name | Class |
|---|---|
| Meir Hospital, Kfar Saba, Israel | OTHER |
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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 Goals:
Study Design:
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:
Exclusion Criteria:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| • Participants will be randomized into two groups: medical management with misoprostol and expectant | No Intervention | expectant management (observation only). | |
| medical management | Experimental | medical management with misoprostol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| medical management with misoprostol | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate effectiveness of medical management | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the complication of expectant versus medical management of RPOC. | infection, uterine adhesions | From the time of enrollment until the completion of follow-up for the first trimester abortion- up to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chen Manor Bar, MD | Contact | +972544414211 | Manor.chen@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meir Medical Center | Recruiting | Kfar Saba | 4861027 | Israel |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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