The Role of Hydrosalpinx in Recurrent Miscarriage

Completed

• Conditions: Abortion, Spontaneous; Hydrosalpinx; Miscarriage, Recurrent
• Interventions: Diagnostic Test: Hysterosalpingo-contrast-sonogram

• Registration Number: NCT03703401
• Lead Sponsor: University of Birmingham

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. 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

Not available

Study Timeline

• Study Start: 2018-02-28
• Study First Submitted: 2018-10-09
• Study First Submitted QC: 2018-10-09
• Study First Posted: 2018-10-12
• Primary Completion: 2020-09-11
• Study Completion: 2021-01-15
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-13
• Last Update Posted: 2022-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 137

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women with recurrent miscarriage and no hydrosalpinx	Hysterosalpingo-contrast-sonogram	-
Women with recurrent miscarriage and treated hydrosalpinx	Hysterosalpingo-contrast-sonogram	-
Women with recurrent miscarriage and concurrent hydrosalpinx	Hysterosalpingo-contrast-sonogram	-

Primary Outcome Measures

Name	Time	Method
Hydrosalpinx	12 months	The presence or absence of tubal blockage and hydrosalpinx

Secondary Outcome Measures

Name	Time	Method
Miscarriage	12 months	The loss of a pregnancy below 24 completed week of gestation

Trial Locations

Locations (1)

Birmingham Womens Hospital; 🇬🇧 Birmingham, West Midands, United Kingdom