The Role of Hydrosalpinx in Recurrent Miscarriage

November 13, 2022 updated by: Dr Jayasish Ghosh, University of Birmingham

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

137

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Midands
      • Birmingham, West Midands, United Kingdom, B15 2TG
        • Birmingham Womens Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women who have suffered from 2 or more pregnancy losses

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women with recurrent miscarriage and no hydrosalpinx
Diagnostic test: Hysterosalpingo-contrast-sonogram
A contrast ultrasound scan to examine fallopian tube pathology and blockage
Women with recurrent miscarriage and concurrent hydrosalpinx
Diagnostic test: Hysterosalpingo-contrast-sonogram
A contrast ultrasound scan to examine fallopian tube pathology and blockage
Women with recurrent miscarriage and treated hydrosalpinx
Diagnostic test: Hysterosalpingo-contrast-sonogram
A contrast ultrasound scan to examine fallopian tube pathology and blockage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hydrosalpinx
Time Frame: 12 months
The presence or absence of tubal blockage and hydrosalpinx
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Miscarriage
Time Frame: 12 months
The loss of a pregnancy below 24 completed week of gestation
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Birmingham

Collaborators

Tommy's

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2018

Primary Completion (Actual)

September 11, 2020

Study Completion (Actual)

January 15, 2021

Study Registration Dates

First Submitted

October 9, 2018

First Submitted That Met QC Criteria

October 9, 2018

First Posted (Actual)

October 12, 2018

Study Record Updates

Last Update Posted (Actual)

November 16, 2022

Last Update Submitted That Met QC Criteria

November 13, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRAS ID 232650

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Miscarriage, Recurrent

Clinical Trials on Hysterosalpingo-contrast-sonogram

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe