The Role of Hydrosalpinx in Recurrent Miscarriage

Abortion, Spontaneous Clinical Trial

Official title:

The Role of Hydrosalpinx in Recurrent Miscarriage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03703401
• Other study ID #: IRAS ID 232650
• Status: Completed
• Start date: February 28, 2018
• Est. completion date: January 15, 2021

Study information

• Verified date: November 2022
• Source: University of Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: January 15, 2021
• Est. primary completion date: September 11, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Hydrosalpinx
• Miscarriage, Recurrent
• Recurrence

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Birmingham Womens Hospital	Birmingham	West Midands

Sponsors (2)

Lead Sponsor	Collaborator
University of Birmingham	Tommy's

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hydrosalpinx	The presence or absence of tubal blockage and hydrosalpinx	12 months
Secondary	Miscarriage	The loss of a pregnancy below 24 completed week of gestation	12 months