Retained Products After Miscarriage Clinical Trial
— HYMMNOfficial title:
The HYsteroscopic Miscarriage MaNagement (HYMMN) Trial
Verified date | August 2023 |
Source | Birmingham Women's and Children's NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 149 |
Est. completion date | November 2, 2022 |
Est. primary completion date | November 2, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Women above 18 years - Women choosing either expectant or medical management of a first-trimester miscarriage =14 weeks gestation - Women wanting to conceive as soon as possible after their miscarriage - Consent to trial processes: (1) undergo follow-up with transvaginal ultrasound for the investigation of RPOC; (2) be randomised to outpatient hysteroscopy for confirmation and treatment or standard management; (3) accept trial follow up procedures - questionnaires, telephone interviews Exclusion Criteria: - Women below 18 years - Women with findings suspicious of gestational trophoblastic disease - Women with fever (=38°C) or sepsis secondary to genital tract infection/endometritis - Women who are unable to understand spoken and written English |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Birmingham Women's Hospital | Birmingham |
Lead Sponsor | Collaborator |
---|---|
Birmingham Women's and Children's NHS Foundation Trust | Tommy's |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of eligible patients | The number of patients approached that fulfill the eligibility criteria for entry into the trial | During recruitment - 6 months | |
Primary | Proportion of patients enrolled into the trial | The proportion of eligible women that agree to participate in the trial | During recruitment - 6 months | |
Primary | Proportion of patients attending scan | The proportion of women that attended the hospital for their 8-week post-miscarriage ultrasound scan | At ultrasound scan 8 weeks post-miscarriage diagnosis | |
Primary | Proportion of patients attending outpatient hysteroscopy (if randomised to this treatment) | Of the women randomised to hysteroscopic treatment of RPOC, the proportion that attended their appointment | During outpatient hysteroscopy (if randomised to this treatment) | |
Primary | Proportion of patients attending 14-week follow-up | The proportion of women that attended follow-up at 14 weeks | 14-week follow up | |
Primary | Proportion of patients attending 26-week follow-up | The proportion of women that attended follow-up at 26 weeks | 26-week follow up | |
Primary | Proportion of patients attending 52-week follow-up | The proportion of women that attended follow-up at 52 weeks | 52-week follow up | |
Primary | Acceptability of trial to eligible women | To determine why patients decline participation into the trial or withdraw after consent | Up to 8 months | |
Primary | Acceptability of ultrasound scan to patients | Acceptability of ultrasound scan to patients as recorded on a questionnaire given to the woman after their ultrasound scan on a 5-point Likert scale | At ultrasound scan 8 weeks post-miscarriage diagnosis | |
Primary | Acceptability of outpatient hysteroscopy to patients | Acceptability of outpatient hysteroscopy to patients, if randomised to this treatment, as recorded on a questionnaire given to the woman after their hysteroscopy on a 5-point Likert scale | During outpatient hysteroscopy (if randomised to this treatment) | |
Primary | Robustness of data collection tools | Assessing the completion of the patient and clinician questionnaires during the course of the study to determine how robust/appropriate the data collection tools are (we would expect at least 90% of the forms to be filled out) | From recruitment of first patient to end of trial (up to 20 months) | |
Secondary | Clinical pregnancy rates | Clinical pregnancy rates | Assessed at 26 and 52 weeks post-randomisation/ultrasound scan | |
Secondary | Time to next pregnancy | Time to next pregnancy | Assessed at 26 and 52 weeks post-randomisation/ultrasound scan | |
Secondary | Symptoms | Number of patients with menstrual bleeding, abdominal pain and vaginal discharge symptoms | 14 weeks post-randomisation/ultrasound scan | |
Secondary | Impact on quality of life | Adapted EuroQol- 5 Dimension (EQ-5D-5L) | 14 weeks post-randomisation/ultrasound scan | |
Secondary | Impact on work | Time absent from work | 14 weeks post-randomisation/ultrasound scan | |
Secondary | Healthcare resource use | Number of consultations, scans, inpatient hospital admissions, overnight stays, treatments administered | 14 weeks post-randomisation/ultrasound scan | |
Secondary | Patient satisfaction | Patient satisfaction of trial process (i.e. ultrasound scan +/- treatment for retained products of conception) on a 10cm visual analogue scale | 14 weeks post-randomisation/ultrasound scan | |
Secondary | Procedural findings at ultrasound | Ultrasound findings of patients categorised into whether RPOC are present or not. If RPOC are present, dimensions of RPOC (in millimeters) and presence of vascularity (yes/no) are to be recorded. | During ultrasound scan 8 weeks post-miscarriage diagnosis | |
Secondary | Ease of diagnosis of retained products of conception (RPOC) | Ease of diagnosis of retained products of conception on ultrasound scan by scan operator on a 10cm visual analogue score | During ultrasound scan 8 weeks post-miscarriage diagnosis | |
Secondary | Procedural findings at outpatient hysteroscopy (in women randomised to this treatment) | Hysteroscopic findings/procedural success in women randomised to outpatient hysteroscopy | During outpatient hysteroscopy (in women randomised to this treatment) | |
Secondary | Ease of removal of RPOC during outpatient hysteroscopy (in women randomised to this treatment) | Ease of hysteroscopic morcellation of RPOC and procedural success from clinician perspective, recorded on a 10cm visual analogue scale | During outpatient hysteroscopy (in women randomised to this treatment) | |
Secondary | Pain experienced by patients undergoing outpatient hysteroscopy (in women randomised to this treatment) | Pain experienced by patients undergoing outpatient hysteroscopy on a 10cm visual analogue scale | During outpatient hysteroscopy (in women randomised to this treatment) | |
Secondary | Proportion of women with adverse pregnancy outcomes at 52 weeks | Proportion of women with no pregnancy or failed pregnancy (ectopic pregnancy, miscarriage) at 52-week follow up | 52 weeks post-randomisation/ultrasound scan | |
Secondary | Hysteroscopic findings in women with adverse pregnancy outcomes at 52 weeks | Hysteroscopic findings in women with adverse pregnancy outcomes at 52 weeks | During outpatient hysteroscopy after 52 weeks post-randomisation/ultrasound scan |