Retained Product of Conception After First Trimester Medical AbortionNCT07534982
Success Rates of Expectant vs. Medical Management for Retained Products After First-Trimester Abortion: Randomized Controlled Trial
A study testing medical management with misoprostol in people with Retained Product of Conception After First Trimester Medical Abortion, run by Yael Yagur at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Retained Product of Conception After First Trimester Medical Abortion
- What is being tested?
- medical management with misoprostol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jul 2024to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Meir Medical Center
Kfar Saba, 4861027
Chen Manor Bar, MD, +972544414211, manor.chen@gmail.com
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- medical management with misoprostol
- Keywords
- RPOC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical management with misoprostolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| • 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 Receives: Drug: medical management with misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From the time of enrollment until the completion of follow-up for the first trimester abortion- up to 12 weeks.
Secondary outcomes (1)
Assess the complication of expectant versus medical management of RPOC.
infection, uterine adhesions
Measured: From the time of enrollment until the completion of follow-up for the first trimester abortion- up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 Jul 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retained Product of Conception After First Trimester Medical AbortionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * 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.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yael Yagur
- Sponsor type
- University, hospital or other
- Collaborators
- Meir Hospital, Kfar Saba, Israel
- Responsible party
- Sponsor-investigator, Yael Yagur, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534982
- Sponsor's protocol ID
- 0056-24MMC
- Status last verified
- Apr 2026
- First submitted
- 1 Dec 2024
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Success Rate After Expectant & Medical Management for a Retained Product of Conception After Medical Termination of Pregnancy in First Trimester Spontaneous Abortion-RCT
- ClinicalTrials.gov ID
- NCT07534982
- Acronym / sponsor ID
- 0056-24MMC
- Keywords
- RPOC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Yael YagurUniversity, hospital or other
- Collaborators
- Meir Hospital, Kfar Saba, Israel
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * 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.
| Arm | Type | Receives |
|---|---|---|
| • Participants will be randomized into two groups: medical management with misoprostol and expectant | No intervention | –expectant management (observation only). |
| medical management | Experimental | Drug: medical management with misoprostolmedical management with misoprostol |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical management with misoprostolFollowing 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. | Drug | medical management |
Primary outcome
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).
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Retained Product of Conception After First Trimester Medical Abortion
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Retained Products of Conception, Hysteroscopy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing medical management with misoprostol in people with Retained Product of Conception After First Trimester Medical Abortion, run by Yael Yagur at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chen Manor Bar, MD (+972544414211, Manor.chen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.