Hysteroscopic Morcellation vs Bipolar Resection for Retained Products of Conception (RPOC): A Pilot Randomised Control Trial

Not Applicable

Recruiting

• Conditions: Retained products of conception; Reproductive Health and Childbirth - Childbirth and postnatal care

• Registration Number: ACTRN12623000967684
• Lead Sponsor: Mercy Hospital for Women

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-06
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1. Women with RPOC as identified on pelvic ultrasound performed at the study institution (Mercy Hospital for Women) or a scan performed by an expert ultrasonologist with COGU (certificate of Obstetrics and Gynaecological Ultrasound) qualifications.
These ultrasound inclusion criteria are:
a) >3ml echogenic material with vasculature into the mass, and/or
b) Greatest diameter of RPOC >18mm
c) Endometrial thickness AP diameter >18mm
2. Women who meet the institution-based criteria for surgical management with operative hysteroscopy
a) >15 days post-partum
b) >30days post miscarriage/termination
3. Women aged over 18 years of age at the time of surgery
4. The surgeon has deemed that hysteroscopic removed is indicated AND the surgeon is accredited in both techniques
5. Participant understands the conditions of the study and are willing to participate for the duration of study including all follow-up.
6. Participant is capable of, and have given, informed consent to their participation in the study.

Exclusion Criteria

1. Non-English speaking or inadequate English literacy
2. Contraindications to operative hysteroscopy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Study feasibility: participant consent rate (number/%)<br>- gained from audit of study enrolment data[ 6months following procedure];Study feasibility: collection rate of complete intraoperative data (%)<br>- gained from audit of study case report forms[ 6months following procedure];Study Feasibility: collection rate of complete post-operative data (%)<br>- gained from audit of study case report forms[ 6months post procedure]