Retained Products of ConceptionRIGHTNCT04804332
Removal of Intrauterine Retained Products of Conception (RPOC) After Miscarriage Guided by Hysteroscopy Trial. A Randomized Controlled Trial.
A study testing Operative hysteroscopy and Expectant management in people with Retained Products of Conception, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Rationale: Elective immediate dilation and curettage (D\&C) for miscarriage is associated with the occurrence of intrauterine adhesions (IUA). IUAs may be associated with subsequent subfertility and premature birth. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Retained Products of Conception
- What is being tested?
- Operative hysteroscopy and Expectant management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Jul 2021to 31 Dec 2030
- 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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients after first trimester miscarriage treated non-surgically with sonographic evidence for the presence of RPOC at follow-up visit after 6 weeks (± 1 week) who have an immediate future pregnancy wish and are willing to give informed consent.
Who cannot join
- Women aged below 18 years
- Women aged over 39 years
- Women not wanting to achieve pregnancy within the first 6 months after non-surgical treatment for miscarriage
- Women with a history of repeated miscarriage defined as 3 or more consecutive pregnancy losses before 20 weeks of pregnancy duration
- Women with untreated and/or untreatable subfertility
- Women presenting with severe uterine bleeding, defined as uterine bleeding that needs acute intervention on medical grounds
Show all 13Show fewer
- Women presenting with severe abdominal pain, defined as abdominal pain that needs acute intervention on medical grounds
- Women with fever (> 38.5° Celsius) or sepsis requiring antibiotic treatment. For the definition of 'sepsis' we refer to the Third International Consensus definitions for Sepsis and Septic Shock (Singer 2016)
- Women with a contraindication for (office) operative hysteroscopy
- Women with a failed non-surgical management for miscarriage, as substantiated by the sonographic finding of an intact gestational sac still in situ
- Women with a congenital uterine anomaly
- Known cervical stenosis making safe uterine access impossible
- Visual or pathological (e.g. on biopsy) evidence of malignancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital
Ghent, 9000
Eline Meireson, Msc, +3293327817, eline.meireson@uzgent.be
Tjalina Hamerlynck, MD
About this study
Rationale: Elective immediate dilation and curettage (D\&C) for miscarriage is associated with the occurrence of intrauterine adhesions (IUA). IUAs may be associated with subsequent subfertility and premature birth. Recent studies have shown that in women with miscarriage, medical treatment (misoprostol/mifepristone) is an effective alternative for curettage. A problem with medication and expectant management is that after initial treatment, sonographic findings during follow-up frequently show incomplete evacuation of uterine retained products of conception (RPOC), which often lead to additional interventions or expectant time-consuming management limiting the benefits of medical treatment.
Objective: To assess, in women with a wish for immediate future pregnancy and RPOC after non-surgical management of a miscarriage, as diagnosed with sonography, the effects of operative hysteroscopy versus expectant management.
Read more
Study design: Multicenter randomized clinical trial. Study population: Patients after non-surgical management of a miscarriage with sonographic evidence of RPOC at the follow-up visit 6 weeks after initial treatment and wish for immediate (within 6 months) future pregnancy.
Intervention: operative hysteroscopy versus expectant management. Main study parameters/endpoints: The primary outcome is time to next pregnancy, as substantiated by a positive urinary or serum hCG test. Secondary outcomes are Quality of Life (QOL) scores assessed with the SF-36, HADS and EQ-5D-5L, the need for additional and/or unscheduled treatments and/or visits and complications. Furthermore, data on the course of pregnancy - including miscarriage, ectopic pregnancy and live birth - are documented in those women who have an ongoing pregnancy after randomization during the study follow up period. In addition, iMTA PCQ questionnaires and health-costs are measured in all patients to perform a cost-effectiveness analysis.
A total of 244 (122 per arm) women will be sufficient to answer the questions on the primary endpoint.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Women participating in the study will be asked to fill out questionnaires at baseline, 8 weeks and 6 months after randomization. We don not expect specific risks as a result of either the intervention or expectant management.
Read the detailed description
Design : RCT
- Multicenter
- Randomized controlled
- Parallel group design
- Superiority trial
- Non-blinded
Primary Objective
To compare the effectiveness in terms of time to next pregnancy between operative hysteroscopy and expectant management in patients with sonographic evidence of RPOC after primary non-surgical management of miscarriage.
Secondary Objectives
- Effectiveness objectives To compare the effectiveness between operative hysteroscopy and expectant management with respect to:
- Generic quality of life (QOL) (as measured by SF-36, HADS (Hospital Anxiety and Depression Scale)) and EQ-5D-5L 6 months after randomization
- Course of pregnancy in those women who have an ongoing pregnancy after randomization during the study follow-up period (including miscarriage, ectopic pregnancy and live birth)
- Safety objectives To compare the safety between operative hysteroscopy and expectant management with respect to:
- Necessity for additional treatment
- Out-of-protocol/unscheduled visits to the outpatient clinic or general practitioner
- Complications
- Cost-effectiveness objectives To compare the health related costs between operative hysteroscopy and expectant management.
- Conditions
- Retained Products of Conception
- Being tested
- Operative hysteroscopy, Expectant management
- Keywords
- Retained Products of Conception, placental remnants, hysteroscopy, expectant management, fertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operative hysteroscopyProcedure or surgery
Operative hysteroscopy is performed without or under local, regional or general anesthesia according to the local protocol preferably within 2 to 3 weeks after randomization. In case of highly vascularized RPOC, a repeat sonogram is performed 2 to 4 weeks after randomization to check for persistence of vascularity and to optimize operative timing. Operative hysteroscopy is then performed within 2 to 3 weeks after the repeat sonogram. Removal of the RPOC is performed by an experienced gynecologist using hysteroscopic morcellation (TruClearTM Hysteroscopic Tissue Removal System (Medtronic, Minneapolis, MN, USA)) and according to the local protocol.
Expectant managementOther
No treatment will be offered. Patients will be given telephone numbers to contact a doctor. In case of severe complaints, defined as heavy uterine bleeding and/or severe abdominal pain, not responding to conservative treatment, an emergency curettage or operative hysteroscopy may be performed.
| Study group | Role | What they receive |
|---|---|---|
| EXPECTANT MANAGEMENT | Experimental | No treatment will be offered. Receives: Other: Expectant management |
| OPERATIVE HYSTEROSCOPY | Experimental | Operative hysteroscopy using hysteroscopic morcellation (TruClearTM Hysteroscopic Tissue Removal System (Medtronic, Minneapolis, MN, USA)) is performed. Receives: Procedure: Operative hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to next pregnancy
The primary endpoint is the time until next pregnancy since randomization, with pregnancy defined as a positive urinary or serum hCG test. Patients are asked to contact the study team in case of pregnancy. If a participant has failed to contact the center, pregnancy will be asked at same time as the questionnaires and then once every 6 months as well as at the end of the study by telephone contact or e-mail.
Measured: up to 3 years after the start of the trial
Secondary outcomes (11)
Quality Of Life (QOL)
measured by SF-36
Measured: at baseline, 8 weeks after randomization and 6 months after randomization
Quality Of Life (QOL)
measured by HADS (Hospital Anxiety and Depression Scale)
Measured: at baseline, 8 weeks after randomization and 6 months after randomization
Quality Of Life (QOL)
measured by EQ-5D-5L
Measured: at baseline, 8 weeks after randomization and 6 months after randomization
Course of pregnancy
Course of pregnancy in those women who have an ongoing pregnancy after randomization during the study follow-up period (including miscarriage, ectopic pregnancy and live birth):
- Time to conception, defined as the time from randomization to the date of conception retrospectively determined based on the crown-rump length measurement (CRL) by a first-trimester ultrasound.
- Clinical pregnancy defined as a pregnancy diagnosed by ultrasonographic visualization of 1 or more gestational sacs or definitive clinical signs of pregnancy, including ectopic pregnancy. Multiple gestational sacs are counted as 1 clinical pregnancy.
- Live birth, defined as the complete expulsion or extraction from the mother of a product of fertilization, irrespective of the duration of pregnancy, which after such separation breathes or shows any other evidence of life, such as heartbeat, umbilical cord pulsation, or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been
Measured: up to 3 years after the start of the trial
Necessity for additional treatment
Necessity for additional treatment
Measured: until 6 months after randomisation
Out-of-protocol/unscheduled visits
Re-interventions or additional treatment during the first 6 months including type, number and reasons.
Out-of-protocol visits to the outpatient clinic or general practitioner or hospitalizations including type, number, reasons and duration of hospitalization.
Measured: until 6 months after randomisation
Complications
Heavy uterine bleeding defined as uterine bleeding that needs acute intervention (IV iron administration, tranexamic acid or blood transfusion) on medical grounds
Measured: until 6 months after randomisation
Complications
Severe abdominal pain requiring analgesics or medical intervention, excluding postoperative pain in the first 48 hours after uterine surgery
Measured: until 6 months after randomisation
Complications
Fever (>38.5° Celsius) or sepsis
Measured: until 6 months after randomisation
Complications
- Related to operative hysteroscopy or other surgical treatment
- uterine perforation
- postoperative hemorrhage, defined as excessive blood loss estimated or measured as ≥ 500 mL and/or need for blood transfusion
- severe abdominal pain requiring analgesics excluding postoperative pain in the first 48 hours after hysteroscopic surgery
- fluid overload (defined as absorption of more than 2500 mL of distention medium with clinical consequences for the patient)
- electrolyte disturbances requiring treatment
- gas embolism
Measured: until 6 months after randomisation
Health related costs
the EQ-5D-5L and health-related costs based on physician visits, hospitalizations and emergency room visits are measured
Measured: until 6 months after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start12 Jul 2021
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retained Products of ConceptionStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Single group
- Model description
- Design : RCT * Multicenter * Randomized controlled * Parallel group design * Superiority trial * Non-blinded
- Masking
- None (open label)
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Tjalina Hamerlynck, MD PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804332
- Sponsor's protocol ID
- BC-08856
- Acronym
- RIGHT
- Status last verified
- Jul 2026
- First submitted
- 8 Mar 2021
- Last updated
- 30 Jul 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 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Removal of Intrauterine Retained Products of Conception (RPOC) After Miscarriage Guided by Hysteroscopy Trial. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04804332
- Acronym / sponsor ID
- RIGHT / BC-08856
- Conditions
- Retained Products of Conception
- Keywords
- Retained Products of Conception, placental remnants, hysteroscopy, expectant management, fertility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 18 Mar 2021 (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.
Rationale: Elective immediate dilation and curettage (D\&C) for miscarriage is associated with the occurrence of intrauterine adhesions (IUA). IUAs may be associated with subsequent subfertility and premature birth. Recent studies have shown that in women with miscarriage, medical treatment (misoprostol/mifepristone) is an effective alternative for curettage. A problem with medication and expectant management is that after initial treatment, sonographic findings during follow-up frequently show incomplete evacuation of uterine retained products of conception (RPOC), which often lead to additional interventions or expectant time-consuming management limiting the benefits of medical treatment.
Objective: To assess, in women with a wish for immediate future pregnancy and RPOC after non-surgical management of a miscarriage, as diagnosed with sonography, the effects of operative hysteroscopy versus expectant management.
Study design: Multicenter randomized clinical trial. Study population: Patients after non-surgical management of a miscarriage with sonographic evidence of RPOC at the follow-up visit 6 weeks after initial treatment and wish for immediate (within 6 months) future pregnancy.
Intervention: operative hysteroscopy versus expectant management. Main study parameters/endpoints: The primary outcome is time to next pregnancy, as substantiated by a positive urinary or serum hCG test. Secondary outcomes are Quality of Life (QOL) scores assessed with the SF-36, HADS and EQ-5D-5L, the need for additional and/or unscheduled treatments and/or visits and complications. Furthermore, data on the course of pregnancy - including miscarriage, ectopic pregnancy and live birth - are documented in those women who have an ongoing pregnancy after randomization during the study follow up period. In addition, iMTA PCQ questionnaires and health-costs are measured in all patients to perform a cost-effectiveness analysis.
A total of 244 (122 per arm) women will be sufficient to answer the questions on the primary endpoint.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Women participating in the study will be asked to fill out questionnaires at baseline, 8 weeks and 6 months after randomization. We don not expect specific risks as a result of either the intervention or expectant management.
Detailed description
Design : RCT
- Multicenter
- Randomized controlled
- Parallel group design
- Superiority trial
- Non-blinded
Primary Objective
To compare the effectiveness in terms of time to next pregnancy between operative hysteroscopy and expectant management in patients with sonographic evidence of RPOC after primary non-surgical management of miscarriage.
Secondary Objectives
- Effectiveness objectives To compare the effectiveness between operative hysteroscopy and expectant management with respect to:
- Generic quality of life (QOL) (as measured by SF-36, HADS (Hospital Anxiety and Depression Scale)) and EQ-5D-5L 6 months after randomization
- Course of pregnancy in those women who have an ongoing pregnancy after randomization during the study follow-up period (including miscarriage, ectopic pregnancy and live birth)
- Safety objectives To compare the safety between operative hysteroscopy and expectant management with respect to:
- Necessity for additional treatment
- Out-of-protocol/unscheduled visits to the outpatient clinic or general practitioner
- Complications
- Cost-effectiveness objectives To compare the health related costs between operative hysteroscopy and expectant management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Design : RCT * Multicenter * Randomized controlled * Parallel group design * Superiority trial * Non-blinded
| Arm | Type | Receives |
|---|---|---|
| EXPECTANT MANAGEMENT | Experimental | Other: Expectant managementNo treatment will be offered. |
| OPERATIVE HYSTEROSCOPY | Experimental | Procedure: Operative hysteroscopyOperative hysteroscopy using hysteroscopic morcellation (TruClearTM Hysteroscopic Tissue Removal System (Medtronic, Minneapolis, MN, USA)) is performed. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients after first trimester miscarriage treated non-surgically with sonographic evidence for the presence of RPOC at follow-up visit after 6 weeks (± 1 week) who have an immediate future pregnancy wish and are willing to give informed consent.
Key exclusion criteria (13 listed)
- Women aged below 18 years
- Women aged over 39 years
- Women not wanting to achieve pregnancy within the first 6 months after non-surgical treatment for miscarriage
- Women with a history of repeated miscarriage defined as 3 or more consecutive pregnancy losses before 20 weeks of pregnancy duration
- Women with untreated and/or untreatable subfertility
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 |
|---|---|---|
| Operative hysteroscopyOperative hysteroscopy is performed without or under local, regional or general anesthesia according to the local protocol preferably within 2 to 3 weeks after randomization. In case of highly vascularized RPOC, a repeat sonogram is performed 2 to 4 weeks after randomization to check for persistence of vascularity and to optimize operative timing. Operative hysteroscopy is then performed within 2 to 3 weeks after the repeat sonogram. Removal of the RPOC is performed by an experienced gynecologist using hysteroscopic morcellation (TruClearTM Hysteroscopic Tissue Removal System (Medtronic, Minneapolis, MN, USA)) and according to the local protocol. | Procedure or surgery | OPERATIVE HYSTEROSCOPY |
| Expectant managementNo treatment will be offered. Patients will be given telephone numbers to contact a doctor. In case of severe complaints, defined as heavy uterine bleeding and/or severe abdominal pain, not responding to conservative treatment, an emergency curettage or operative hysteroscopy may be performed. | Other | EXPECTANT MANAGEMENT |
Primary outcome
Time to next pregnancy
Time frame: up to 3 years after the start of the trial
The primary endpoint is the time until next pregnancy since randomization, with pregnancy defined as a positive urinary or serum hCG test. Patients are asked to contact the study team in case of pregnancy. If a participant has failed to contact the center, pregnancy will be asked at same time as the questionnaires and then once every 6 months as well as at the end of the study by telephone contact or e-mail.
11 secondary outcomes
Quality Of Life (QOL)
Time frame: at baseline, 8 weeks after randomization and 6 months after randomization
Quality Of Life (QOL)
Time frame: at baseline, 8 weeks after randomization and 6 months after randomization
Quality Of Life (QOL)
Time frame: at baseline, 8 weeks after randomization and 6 months after randomization
Course of pregnancy
Time frame: up to 3 years after the start of the trial
Necessity for additional treatment
Time frame: until 6 months after randomisation
Out-of-protocol/unscheduled visits
Time frame: until 6 months after randomisation
Complications
Time frame: until 6 months after randomisation
Complications
Time frame: until 6 months after randomisation
Complications
Time frame: until 6 months after randomisation
Complications
Time frame: until 6 months after randomisation
Health related costs
Time frame: until 6 months after randomisation
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 30 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Tjalina Hamerlynck, MD PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Operative hysteroscopy and Expectant management in people with Retained Products of Conception, run by University Hospital, Ghent at 1 site in Belgium.
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 1 inclusion and 13 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 30 Jul 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 Belgium. 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 Eline Meireson (+3293327817, eline.meireson@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to next pregnancy (time frame: up to 3 years after the start of the trial). 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 30 Jul 2026.