The HYsteroscopic Miscarriage MaNagement Trial: A Pilot RCT Investigating a Novel Management Pathway for RPOC
Status:
Recruiting
Trial end date:
2022-11-01
Target enrollment:
Participant gender:
Summary
Pregnancy tissue can be found remaining in the womb in up to 20% of women following a
miscarriage. These "retained products of conception" (RPOC), which are diagnosed by
transvaginal ultrasound, can cause prolonged bleeding, pain, infection, impaired fertility
and therefore further psychological distress. Ineffective medical and surgical interventions
place considerable burden on affected women and utilise scarce health care resources.
Additionally, surgery is performed 'blindly' using a suction tube or metal curette where
risks include perforation of the womb and scarring of the womb lining, both of which lead to
delayed fertility and in the worst circumstances, infertility.
There is no current guidance on how to best investigate and manage RPOC. New surgical
equipment allows RPOC removal under vision, using a specially designed telescope placed
inside the womb (hysteroscopy). This precise technique may more successfully and less
traumatically remove RPOC, minimising ongoing bleeding, the risk of womb perforation and scar
tissue formation, thereby reducing the risk of infertility.
The investigators propose a pilot randomised controlled trial using routine transvaginal
ultrasound to diagnose RPOC in women who choose non-surgical management of a first-trimester
(≤14 weeks) miscarriage. This scan will be done 8 weeks post-miscarriage diagnosis. Women who
have RPOC on this scan will be randomised (in a 1:1 ratio) to receive outpatient hysteroscopy
('OPH') or 'standard treatment' (expectant, medical, surgical and/or antibiotic treatment).
Women who had RPOC will be followed-up at 14 weeks after randomisation to explore clinical
outcomes (symptoms, quality of life) and use of additional healthcare resources (e.g.
additional investigations / treatments / hospitalisations). All patients, no matter whether
they were diagnosed with RPOC or not, will be followed up at 26 weeks and 52 weeks after
randomisation/ultrasound scan to determine clinical pregnancy rates and pregnancy outcomes.
All patients who have had a miscarriage or have not fallen pregnant since entering the trial
will be offered a hysteroscopy to see if there are any conditions affecting the womb lining
which may be contributing to pregnancy failure.
Phase:
N/A
Details
Lead Sponsor:
Birmingham Women's and Children's NHS Foundation Trust