RIGHT
Research type
Research Study
Full title
RIGHT: Removal of Intrauterine Retained products of conception (RPOC) after miscarriage Guided by Hysteroscopy Trial: a randomized controlled trial.
IRAS ID
302866
Contact name
T. Justin Clark
Contact email
Sponsor organisation
UZ Gent
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 30 days
Research summary
1 in 4 pregnancies unfortunately ends in a miscarriage which is the failure of pregnancy before 24 weeks gestation. Women can be offered expectant management (giving time for the pregnancy to pass by itself), medical management (involving medications which cause the womb to contract to expel the pregnancy sooner) or surgical management (involving the ‘blind’ use of a suction tube passed into the womb, often under a general anaesthetic).
Retained products of conception (RPOC) are found in up to 20% of women following a miscarriage. The above treatment options used to manage miscarriage are also offered for RPOC, however, because there is no evidence on how well they work, symptoms such as bleeding and pain can be prolonged. This requires further hospital visits and inpatient admissions, thus causing significant physiological and psychological stress to women and their partners as well as the additional use of healthcare resources. Fertility can be delayed, or worse, permanently impaired, because of damage and scarring of the womb lining due to either chronic inflammation from the RPOC themselves or from mechanical trauma following surgical management.
Observational studies show that performing hysteroscopy (a small telescope already being used to diagnose and treat conditions affecting womb lining) to remove RPOC may be associated with higher rates of uterine evacuation and less time to the next pregnancy. There, however, has never been a head-to-head comparison of treatment with hysteroscopy versus no treatment to demonstrate the efficacy of this proposed novel treatment.
We therefore propose a randomised controlled trial that involves the routine use of ultrasound scanning for RPOC and randomisation of affected women to either have hysteroscopy or no treatment allowing for comparison of pregnancy rates, quality of life and healthcare resource use.
REC name
London - Surrey Research Ethics Committee
REC reference
22/LO/0598
Date of REC Opinion
5 Dec 2022
REC opinion
Further Information Favourable Opinion