The Role of Hydrosalpinx in Recurrent Miscarriage

Study Overview
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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 Establish the prevalence of hydrosalpinx in the recurrent miscarriage population. Establish the prognosis of women diagnosed with recurrent miscarriage with concurrent hydrosalpinx. Explore the role of tubal surgery for improving reproductive outcomes in women with recurrent miscarriage population and hydrosalpinx.

Official Title
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The Role of Hydrosalpinx in Recurrent Miscarriage

Conditions
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Abortion, Spontaneous, Miscarriage, Recurrent, Hydrosalpinx

Intervention / Treatment
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* Diagnostic Test: Hysterosalpingo-contrast-sonogram


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women with recurrent miscarriage and no hydrosalpinx<br> | Diagnostic Test: Hysterosalpingo-contrast-sonogram<br>* A contrast ultrasound scan to examine fallopian tube pathology and blockage<br>|
| Women with recurrent miscarriage and concurrent hydrosalpinx<br> | Diagnostic Test: Hysterosalpingo-contrast-sonogram<br>* A contrast ultrasound scan to examine fallopian tube pathology and blockage<br>|
| Women with recurrent miscarriage and treated hydrosalpinx<br> | Diagnostic Test: Hysterosalpingo-contrast-sonogram<br>* A contrast ultrasound scan to examine fallopian tube pathology and blockage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hydrosalpinx | The presence or absence of tubal blockage and hydrosalpinx | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Miscarriage | The loss of a pregnancy below 24 completed week of gestation | 12 months |