Hysteroscopy for treating retained products of conception after miscarriage

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

This study tests whether a procedure called hysteroscopy helps women who had a miscarriage and still have some pregnancy tissue to get pregnant again faster compared to just waiting it out.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 244 (estimated)
• Ages: 18 Years to 39 Years
• Sex: Female
• Sponsor: University Hospital, Ghent (other)
• Locations: 1 site (Ghent)
• Trial ID: NCT04804332 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of operative hysteroscopy compared to expectant management in women who have experienced a miscarriage and have retained products of conception (RPOC) as confirmed by ultrasound. The study aims to determine which approach leads to a quicker return to pregnancy for women wishing to conceive again. It is a multicenter, randomized controlled trial that will assess not only the time to the next pregnancy but also the quality of life, safety, and cost-effectiveness of both treatment options. Participants will be monitored for complications and the course of any subsequent pregnancies.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 to 39 who have had a first trimester miscarriage and wish to conceive again within six months.

Not a fit: Patients who are not planning to achieve pregnancy soon, those with repeated miscarriages, or those with severe medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for women with RPOC, potentially leading to quicker pregnancies and better overall reproductive health.

How similar studies have performed: Previous studies have indicated that medical management can be effective for RPOC, but this specific approach using hysteroscopy is being evaluated for the first time in this context.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Where this trial is running

Ghent

• Ghent University Hospital — Ghent, Belgium (RECRUITING)

Study contacts

• Principal investigator: Tjalina Hamerlynck, MD PhD — University Hospital, Ghent
• Study coordinator: Eline Meireson

Conditions: Retained Products of Conception, placental remnants, hysteroscopy, expectant management, fertility