The Role of Hydrosalpinx in Recurrent Miscarriage

NCT ID: NCT03703401

Last Updated: 2022-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

137 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-28

Study Completion Date

2021-01-15

Brief Summary

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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.

Detailed Description

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Conditions

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Abortion, Spontaneous Miscarriage, Recurrent Hydrosalpinx

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Women with recurrent miscarriage and no hydrosalpinx

Hysterosalpingo-contrast-sonogram

Intervention Type DIAGNOSTIC_TEST

A contrast ultrasound scan to examine fallopian tube pathology and blockage

Women with recurrent miscarriage and concurrent hydrosalpinx

Hysterosalpingo-contrast-sonogram

Intervention Type DIAGNOSTIC_TEST

A contrast ultrasound scan to examine fallopian tube pathology and blockage

Women with recurrent miscarriage and treated hydrosalpinx

Hysterosalpingo-contrast-sonogram

Intervention Type DIAGNOSTIC_TEST

A contrast ultrasound scan to examine fallopian tube pathology and blockage

Interventions

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Hysterosalpingo-contrast-sonogram

A contrast ultrasound scan to examine fallopian tube pathology and blockage

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tommy's

OTHER

Sponsor Role collaborator

University of Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Dr Jayasish Ghosh

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Birmingham Womens Hospital

Birmingham, West Midands, United Kingdom

Site Status

Countries

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United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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IRAS ID 232650

Identifier Type: -

Identifier Source: org_study_id

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