Abortion, SpontaneousNCT03703401
The Role of Hydrosalpinx in Recurrent Miscarriage
An observational study of Abortion, Spontaneous and Miscarriage, Recurrent, run by University of Birmingham at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Abortion, Spontaneous, Miscarriage, Recurrent, Hydrosalpinx
- What is being tested?
- Hysterosalpingo-contrast-sonogram
- How many people
- 137 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Feb 2018to 15 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women who have suffered from 2 or more pregnancy losses
Who may be able to join
- Age 18-45
- Women diagnosed with recurrent miscarriage i.e. 2 or more miscarriages
- Ability to give informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Birmingham Womens Hospital
Birmingham, West Midands, B15 2TG
About this study
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.
- Conditions
- Abortion, Spontaneous, Miscarriage, Recurrent, Hydrosalpinx
- Being tested
- Hysterosalpingo-contrast-sonogram
- Medical subject headings
- Abortion, Spontaneous, Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hysterosalpingo-contrast-sonogramDiagnostic test
A contrast ultrasound scan to examine fallopian tube pathology and blockage
| Study group | Role | What they receive |
|---|---|---|
| Women with recurrent miscarriage and no hydrosalpinx | Not described Receives: Diagnostic Test: Hysterosalpingo-contrast-sonogram | |
| Women with recurrent miscarriage and concurrent hydrosalpinx | Not described Receives: Diagnostic Test: Hysterosalpingo-contrast-sonogram | |
| Women with recurrent miscarriage and treated hydrosalpinx | Not described Receives: Diagnostic Test: Hysterosalpingo-contrast-sonogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hydrosalpinx
The presence or absence of tubal blockage and hydrosalpinx
Measured: 12 months
Secondary outcomes (1)
Miscarriage
The loss of a pregnancy below 24 completed week of gestation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start28 Feb 2018
- Primary completion11 Sep 2020
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion, SpontaneousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Tommy's
- Responsible party
- Principal investigator, Dr Jayasish Ghosh, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703401
- Sponsor's protocol ID
- IRAS ID 232650
- Status last verified
- Nov 2022
- First submitted
- 9 Oct 2018
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Hydrosalpinx in Recurrent Miscarriage
- ClinicalTrials.gov ID
- NCT03703401
- Acronym / sponsor ID
- IRAS ID 232650
- Conditions
- Abortion, Spontaneous, Miscarriage, Recurrent, Hydrosalpinx
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Tommy's
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 11 Sep 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 12 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Women with recurrent miscarriage and no hydrosalpinx | – | Diagnostic Test: Hysterosalpingo-contrast-sonogram |
| Women with recurrent miscarriage and concurrent hydrosalpinx | – | Diagnostic Test: Hysterosalpingo-contrast-sonogram |
| Women with recurrent miscarriage and treated hydrosalpinx | – | Diagnostic Test: Hysterosalpingo-contrast-sonogram |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women who have suffered from 2 or more pregnancy losses
Key inclusion criteria (3 listed)
- Age 18-45
- Women diagnosed with recurrent miscarriage i.e. 2 or more miscarriages
- Ability to give informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hysterosalpingo-contrast-sonogramA contrast ultrasound scan to examine fallopian tube pathology and blockage | Diagnostic test | Women with recurrent miscarriage and concurrent hydrosalpinx, Women with recurrent miscarriage and no hydrosalpinx, Women with recurrent miscarriage and treated hydrosalpinx |
Primary outcome
Hydrosalpinx
Time frame: 12 months
The presence or absence of tubal blockage and hydrosalpinx
1 secondary outcome
Miscarriage
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abortion, Spontaneous and Miscarriage, Recurrent, run by University of Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hydrosalpinx (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.