The HYsteroscopic Miscarriage MaNagement Trial: A Pilot RCT Investigating a Novel Management Pathway for RPOC

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.

Conditions

• Retained Products After Miscarriage

Interventions

PROCEDURE

Outpatient hysteroscopy

Direct visualisation and careful extraction of retained pregnancy tissue using a specific hysteroscopic technology known as a hysteroscopic tissue retrieval system.

BEHAVIORAL

Expectant management

Leaving the retained pregnancy tissue alone to pass by itself

DRUG

Medical management

Giving medications to contract the womb to pass the retained pregnancy tissue

DRUG

Antibiotic

Giving antibiotics to reduce any inflammation/infection caused by the retained pregnancy tissue allowing it to pass by itself

PROCEDURE

Surgical management

Passing a small cannula/catheter/currette into the womb and mechanically scraping the womb lining to remove the retained pregnancy tissue

Sponsors & Collaborators

• Tommy's

  collaborator OTHER

• Birmingham Women's and Children's NHS Foundation Trust

  lead OTHER

Principal Investigators

• T Justin Clark, FRCOG · Birmingham Women's NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-31

Primary Completion

2022-11-02

Completion

2022-11-02

Countries

• United Kingdom

Study Locations