Recurrent MiscarriagesNCT02746588
Description of the Uterine Cavity in Patients With Recurrent Miscarriages
An observational study of Recurrent Miscarriages and Habitual Abortions, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
To be diagnosed with recurrent miscarriages, a couple might have a child, however experiences three or more miscarriages, primarily this happens during the first trimester. These miscarriages often needs medical evacuation or a D \& C. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recurrent Miscarriages, Habitual Abortions
- What is being tested?
- Office hysteroscopy
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2016to 1 Jan 2019
- 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
- Healthy volunteers accepted
- Adult
Study population: Patients diagnosed with recurrent miscarriages and refurred to the specialist facility af Rigshospitalet
Who may be able to join
- Correctly diagnosed with recurrent miscarriages
Who cannot join
- Known course of the condition
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Hvidovre Hospital, Department of Gynecology and Obstetrics
Copenhagen, Hvidovre, 2650
About this study
To be diagnosed with recurrent miscarriages, a couple might have a child, however experiences three or more miscarriages, primarily this happens during the first trimester.
These miscarriages often needs medical evacuation or a D \& C. Surgery or retained tissue increases the risk of complications as infection and/or adhesions, known as asherman syndrome, which may result in subfertility.
Read more
Recently chronic infection in the endometrium has been proposed to contribute to the condition, as protocols including treatment with antibiotics have led to birth at term for some of these women.
Using the very minimal invasive office hysteroscopy, the investigators aim to describe the uterine cavity in patients diagnosed with recurrent miscarriages regarding both abnormalities in the endometrium and chromic infection.
Read the detailed description
The Unit for Recurrent Pregnancy-loss at Rigshospitalet treats about 300 of couples with recurrent miscarriages a year. Together with the current examination program, the investigators plan to describe the uterine cavity according to abnormalities as septa, adhesions and further the condition for the endometrium regarding infection and hormone receptors. This description will include descriptive office hysteroscopy with biopsies for histologic - and immunohistochemically examinations.
- Conditions
- Recurrent Miscarriages, Habitual Abortions
- Being tested
- Office hysteroscopy
- Keywords
- miscarriage, uterine abnormalities, Chronic infection
- Medical subject headings
- Abortion, Habitual, Abortion, Spontaneous, Uterine Anomalies, Persistent Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Office hysteroscopyOther
Diagnostic hysteroscopy with biopsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the Uterine Cavity in Patients With Recurrent Miscarriages
Observational study describing the uterine cavity in a selected patient group regarding abnormalities
Measured: 1 year
Description of the Uterine Cavity in Patients With Recurrent Miscarriages
Observational study describing the uterine cavity in a selected patient group regarding chronic infection
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study start1 Feb 2016
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent MiscarriagesStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristine Juul Hare, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746588
- Sponsor's protocol ID
- H-15011157
- Status last verified
- Mar 2022
- First submitted
- 18 Apr 2016
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of the Uterine Cavity in Patients With Recurrent Miscarriages
- ClinicalTrials.gov ID
- NCT02746588
- Acronym / sponsor ID
- H-15011157
- Conditions
- Recurrent Miscarriages, Habitual Abortions
- Keywords
- miscarriage, uterine abnormalities, Chronic infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 21 Apr 2016 (estimated)
- 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.
To be diagnosed with recurrent miscarriages, a couple might have a child, however experiences three or more miscarriages, primarily this happens during the first trimester.
These miscarriages often needs medical evacuation or a D \& C. Surgery or retained tissue increases the risk of complications as infection and/or adhesions, known as asherman syndrome, which may result in subfertility.
Recently chronic infection in the endometrium has been proposed to contribute to the condition, as protocols including treatment with antibiotics have led to birth at term for some of these women.
Using the very minimal invasive office hysteroscopy, the investigators aim to describe the uterine cavity in patients diagnosed with recurrent miscarriages regarding both abnormalities in the endometrium and chromic infection.
Detailed description
The Unit for Recurrent Pregnancy-loss at Rigshospitalet treats about 300 of couples with recurrent miscarriages a year. Together with the current examination program, the investigators plan to describe the uterine cavity according to abnormalities as septa, adhesions and further the condition for the endometrium regarding infection and hormone receptors. This description will include descriptive office hysteroscopy with biopsies for histologic - and immunohistochemically examinations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients diagnosed with recurrent miscarriages and refurred to the specialist facility af Rigshospitalet
Key inclusion criteria (1 listed)
- Correctly diagnosed with recurrent miscarriages
Key exclusion criteria (1 listed)
- Known course of the condition
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 |
|---|---|---|
| Office hysteroscopyDiagnostic hysteroscopy with biopsy | Other | – |
Primary outcome
Description of the Uterine Cavity in Patients With Recurrent Miscarriages
Time frame: 1 year
Observational study describing the uterine cavity in a selected patient group regarding abnormalities
Description of the Uterine Cavity in Patients With Recurrent Miscarriages
Time frame: 1 year
Observational study describing the uterine cavity in a selected patient group regarding chronic infection
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 29 Mar 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 Recurrent Miscarriages and Habitual Abortions, run by Hvidovre University Hospital at 1 site in Denmark.
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 1 inclusion and 1 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 29 Mar 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 Denmark. 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?
Description of the Uterine Cavity in Patients With Recurrent Miscarriages (time frame: 1 year). The study lists 2 primary outcomes in all. 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 29 Mar 2022.