CompletedNot Applicable

The Role of Hydrosalpinx in Recurrent Miscarriage

United Kingdom137 participantsStarted 2018-02-28

Plain-language summary

Miscarriage affects one in five pregnancies and little progress has been made in understanding and treating this distressing condition. C. trachomatis is the most common sexually transmitted infection in the UK. C. trachomatis infection can have serious health consequences, including fallopian tube damage. Untreated C. trachomatis infection and tubal damage have been associated with miscarriage and adverse pregnancy outcomes such as preterm birth, low birth weight and stillbirth. A cohort study is needed to establish the prevalence of tubal disease in women with recurrent miscarriages. HyCoSy will be performed to identify tubal disease and establish the magnitude of the problem in the recurrent miscarriage population. The prognosis of tubal disease on miscarriage and other obstetric outcomes, and the role of medical interventions such as tubal surgery (to treat hydrosalpinx) on reducing miscarriage and adverse obstetric outcomes will also be studied. Objectives 1. Establish the prevalence of hydrosalpinx in the recurrent miscarriage population. 2. Establish the prognosis of women diagnosed with recurrent miscarriage with concurrent hydrosalpinx. 3. Explore the role of tubal surgery for improving reproductive outcomes in women with recurrent miscarriage population and hydrosalpinx.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18-45 * Women diagnosed with recurrent miscarriage i.e. 2 or more miscarriages * Ability to give informed consent Exclusion Criteria: * Allergy to contrast media used for Hysterosalpingo-contrast-sonogram * Allergy to sonographic gel used for ultrasound scanning * Anatomical anomaly meaning transvaginal ultrasound scan not possible * Stenosed/occluded cervix meaning contrast media unable to be introduced via cervix * Inability to give informed consent * Pregnant at the time of recruitment * Declined recruitment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hydrosalpinx

Timeframe: 12 months

Trial details

NCT IDNCT03703401

SponsorUniversity of Birmingham

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-09-11

View on ClinicalTrials.gov More Abortion, Spontaneous trials