The Role of Hydrosalpinx in Recurrent Miscarriage

NCT03703401 | Completed

• 1 other identifier: IRAS ID 232650
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 1

Brief 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. 1.Establish the prevalence of hydrosalpinx in the recurrent miscarriage population.
2. 2.Establish the prognosis of women diagnosed with recurrent miscarriage with concurrent hydrosalpinx.
3. 3.Explore the role of tubal surgery for improving reproductive outcomes in women with recurrent miscarriage population and hydrosalpinx.

Conditions

Abortion, Spontaneous; Miscarriage, Recurrent; Hydrosalpinx

Outcome Measures

Primary Outcomes (1)

• Hydrosalpinx

  The presence or absence of tubal blockage and hydrosalpinx

  12 months

Secondary Outcomes (1)

• Miscarriage

  12 months

Study Arms (3)

Women with recurrent miscarriage and no hydrosalpinx

Diagnostic Test: Hysterosalpingo-contrast-sonogram

Women with recurrent miscarriage and concurrent hydrosalpinx

Diagnostic Test: Hysterosalpingo-contrast-sonogram

Women with recurrent miscarriage and treated hydrosalpinx

Diagnostic Test: Hysterosalpingo-contrast-sonogram

Interventions

Hysterosalpingo-contrast-sonogram DIAGNOSTIC_TEST

A contrast ultrasound scan to examine fallopian tube pathology and blockage

Women with recurrent miscarriage and concurrent hydrosalpinx; Women with recurrent miscarriage and no hydrosalpinx; Women with recurrent miscarriage and treated hydrosalpinx

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Must be genetically female as must have suffered from previous pregnancy losses
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women who have suffered from 2 or more pregnancy losses

You may qualify if:

• Age 18-45
• Women diagnosed with recurrent miscarriage i.e. 2 or more miscarriages
• Ability to give informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Birmingham: lead
• Tommy's: collaborator

Study Sites (1)

Birmingham Womens Hospital

Birmingham, West Midands, B15 2TG, United Kingdom

Location

MeSH Terms

Conditions

Abortion, Spontaneous; Abortion, Habitual

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 12, 2018
• Study Start: February 28, 2018
• Primary Completion: September 11, 2020
• Study Completion: January 15, 2021
• Last Updated: November 16, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)