Clinical Trials Logo
  1. Home
  2. Abortion, Spontaneous
  3. NCT03703401
  4. Details
NCT03703401 Clinical Trial

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
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
See also
  Status Clinical Trial Phase
Completed NCT05449171 - High Molecular Weight Hyaluronic Acid, α-lipoic Acid, Magnesium, Vitamin B6 and Vitamin D, in the Prevention of Spontaneous Abortion N/A
Active, not recruiting NCT05896657 - Modulation of Reproductive Microbiota by Ligilactobacillus Salivarius CECT5713 N/A
Active, not recruiting NCT03736681 - Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage Phase 1
Completed NCT03636451 - Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage.o Phase 3
Completed NCT01335802 - Relation Between Subclinical Hypothyroidism and Outcome of Pregnancy
Recruiting NCT05516810 - The Accuracy of Ultrasound Diagnosis of Hydatidiform Moles
Completed NCT04446572 - Application of Lactobacillus Salivarius CECT5713 in Infertility of Unknown Origin Phase 2
Completed NCT01033903 - Optimal Treatment of Miscarriage N/A
Withdrawn NCT02328742 - Development of a Bioabsorbable Medical Device for the Prevention of Postoperative Intra-uterine Adhesions. N/A
Completed NCT01762098 - Chronic Endometritis in Patients With Recurrent Miscarriages or Repeated Implantation Failures in In-vitro Fertilization N/A
Active, not recruiting NCT04360564 - RPL: Interval to Live Birth and Adverse Perinatal Outcomes
Completed NCT04791020 - Topic Cervical Anesthesia Plus Paracervical Blockade for Pain Control During Endouterine Manual Aspiration N/A
Recruiting NCT03220750 - University Hospital Advanced Age Pregnant Cohort N/A
Completed NCT01904669 - Internet-based Study of Fertility and Early Pregnancy (PEEPS) N/A
Not yet recruiting NCT00491270 - Bacterial Vaginosis Screening and Treatment to Reduce Infective Complications, Abortion and Preterm Delivery Phase 3
Active, not recruiting NCT02434900 - Vitamin D and Angiogenic Markers in Odense Child Cohort 1 N/A
Completed NCT01788540 - Intralipid for Recurrent Miscarriage Phase 4
Recruiting NCT02633475 - Interleukin-10 Promoter-1082A/G Polymorphism and Idiopathic Recurrent Miscarriage Risk N/A
Completed NCT02761772 - Early Pregnancy Cohort and Preimplantation Factor
Not yet recruiting NCT00256009 - Treatment of Late Abortion: Evacuatio Uteri or Conservative Treatment Phase 4