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OpenTrials
Completed

NCT Number: NCT03703401

The Role of Hydrosalpinx in Recurrent Miscarriage

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Birmingham Womens Hospital

Birmingham, West Midands, B15 2TG, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hysterosalpingo-contrast-sonogram

Diagnostic Test

A contrast ultrasound scan to examine fallopian tube pathology and blockage

Primary outcomes

  1. Hydrosalpinx

    Time frame: 12 months

    The presence or absence of tubal blockage and hydrosalpinx

Secondary outcomes

  1. Miscarriage

    Time frame: 12 months

    The loss of a pregnancy below 24 completed week of gestation

Sponsors and collaborators

Lead sponsor

University of Birmingham

Other

Collaborators

  • Tommy's

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Oct 12, 2018
Registry last updated
Nov 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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