Removal of Intrauterine Retained Products of Conception (RPOC) After Miscarriage Guided by Hysteroscopy Trial. A Randomized Controlled Trial.

NCT04804332 | Recruiting

• 1 other identifier: BC-08856
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Retained Products of Conception

Keywords

Retained Products of Conception; placental remnants; hysteroscopy; expectant management; fertility

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 3 years after the start of the trial

Secondary Outcomes (11)

• Quality Of Life (QOL)

  at baseline, 8 weeks after randomization and 6 months after randomization

• Quality Of Life (QOL)

  at baseline, 8 weeks after randomization and 6 months after randomization

• Quality Of Life (QOL)

  at baseline, 8 weeks after randomization and 6 months after randomization

• Course of pregnancy

  up to 3 years after the start of the trial

• Necessity for additional treatment

  until 6 months after randomisation

Study Arms (2)

EXPECTANT MANAGEMENT

EXPERIMENTAL

No treatment will be offered.

Other: Expectant management

OPERATIVE HYSTEROSCOPY

EXPERIMENTAL

Operative hysteroscopy using hysteroscopic morcellation (TruClearTM Hysteroscopic Tissue Removal System (Medtronic, Minneapolis, MN, USA)) is performed.

Procedure: Operative hysteroscopy

Interventions

Operative hysteroscopy PROCEDURE

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.

OPERATIVE HYSTEROSCOPY

Expectant management OTHER

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.

EXPECTANT MANAGEMENT

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Medtronic: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Tjalina Hamerlynck, MD PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eline Meireson

CONTACT

+3293327817; eline.meireson@uzgent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Design : RCT * Multicenter * Randomized controlled * Parallel group design * Superiority trial * Non-blinded

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 18, 2021
• Study Start: July 12, 2021
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)