The Role of Hydrosalpinx in Recurrent Miscarriage

Overview

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 Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 11, 2020

Interventions

  • Diagnostic Test: Hysterosalpingo-contrast-sonogram
    • A contrast ultrasound scan to examine fallopian tube pathology and blockage

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Hydrosalpinx
    • Time Frame: 12 months
    • The presence or absence of tubal blockage and hydrosalpinx

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Must be genetically female as must have suffered from previous pregnancy losses

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Birmingham
  • Collaborator
    • Tommy’s
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr Jayasish Ghosh, Principal Investigator – University of Birmingham

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.