HYMMN v1.0
Research type
Research Study
Full title
The HYsteroscopic Miscarriage MaNagement (HYMMN) Trial
IRAS ID
276909
Contact name
Prathiba De Silva
Contact email
Sponsor organisation
Birmingham Women's and Children's NHS Foundation Trust
Duration of Study in the UK
1 years, 10 months, 12 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 in the outpatient setting) to remove RPOC may be associated with higher rates of uterine evacuation and less time to the next pregnancy.
We therefore propose a pilot randomised controlled trial that involves the routine use of ultrasound scanning for RPOC and randomisation of affected women to either have hysteroscopy or current treatment (expectant, medical, surgical management), allowing for comparison of pregnancy rates, bleeding, quality of life and healthcare resource use. Performing this pilot study prior to the main study can avoid trials that will fail and increase the likelihood of success of the main study.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
20/WM/0287
Date of REC Opinion
18 Dec 2020
REC opinion
Further Information Favourable Opinion