PregnancyTDOCNCT02815501
Thyroid Dysfunction and Obstetric Complications
An observational study of Pregnancy, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Obstetric complications are common and can be responsible for maternal and foetal morbidity and mortality. Thyroid dysfunction has been identified as a possible cause of obstetric complications. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- blood samples
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2012to 26 Oct 2017
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: women attending the emergency room and/or hospitalised or followed for: * Spontaneous and/or repeated miscarriage * Foetal death * Pre-eclampsia * Retroplacental haematoma * Post-partum haemorrhage * Premature delivery
Who may be able to join
- women attending the emergency room and/or hospitalised or followed for:
- Spontaneous and/or repeated miscarriage
- Foetal death
- Pre-eclampsia
- Retroplacental haematoma
- Post-partum haemorrhage
Show all 9Show fewer
- Premature delivery
- who consent to participate in the study.
- Assessment of these women will include blood samples for a laboratory work-up and anti-thyroid antibodies.
Who cannot join
- normal pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Obstetric complications are common and can be responsible for maternal and foetal morbidity and mortality. Thyroid dysfunction has been identified as a possible cause of obstetric complications.
Many studies have been conducted to estimate the prevalence and define the nature of obstetric complications observed in patients with thyroid dysfunction. However, women with obstetric complications are not systematically screened for thyroid dysfunction and no published study has evaluated the prevalence of thyroid dysfunction in women with an obstetric complication. As no consensus has been reached concerning systematic screening for thyroid dysfunction in pregnant women, the identification of new high-risk populations could possibly result in a change of clinical practice.
- Conditions
- Pregnancy
- Being tested
- blood samples
- Keywords
- Thyroid dysfunction, obstetric complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesBiological
for the determination of thyroid hormones (TSH, FT3, FT4 ) and antibodies against the thyroid (anti TPO antibodies and anti thyroglobulin)
| Study group | Role | What they receive |
|---|---|---|
| women | attending the emergency room and/or hospitalised or followed for: Spontaneous and/or repeated miscarriage Foetal death Pre-eclampsia Retroplacental haematoma Post-partum haemorrhage Premature delivery
Blood samples Receives: Biological: blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of thyroid dysfunction
Estimate the overall and individual prevalence of thyroid dysfunction (hypothyroidism, hyperthyroidism and thyroid autoimmunity) in patients with obstetrical accident
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study start1 Mar 2012
- Primary completion26 Oct 2017
- Study completion26 Oct 2017
Why it stopped: Investigator choice
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel DESAILLOUD, MD, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815501
- Sponsor's protocol ID
- PI11-PR-DESAILLOUD 2
- Acronym
- TDOC
- Status last verified
- Jul 2020
- First submitted
- 24 Jun 2016
- Last updated
- 15 Jul 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Dysfunction and Obstetric Complications
- ClinicalTrials.gov ID
- NCT02815501
- Acronym / sponsor ID
- TDOC / PI11-PR-DESAILLOUD 2
- Conditions
- Pregnancy
- Keywords
- Thyroid dysfunction, obstetric complications
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Investigator choice
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Mar 2012 (actual)
- Primary completion
- 26 Oct 2017 (actual)
- Study completion
- 26 Oct 2017 (actual)
- First posted
- 28 Jun 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.
Obstetric complications are common and can be responsible for maternal and foetal morbidity and mortality. Thyroid dysfunction has been identified as a possible cause of obstetric complications.
Many studies have been conducted to estimate the prevalence and define the nature of obstetric complications observed in patients with thyroid dysfunction. However, women with obstetric complications are not systematically screened for thyroid dysfunction and no published study has evaluated the prevalence of thyroid dysfunction in women with an obstetric complication. As no consensus has been reached concerning systematic screening for thyroid dysfunction in pregnant women, the identification of new high-risk populations could possibly result in a change of clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women | – | Biological: blood samplesattending the emergency room and/or hospitalised or followed for: Spontaneous and/or repeated miscarriage Foetal death Pre-eclampsia Retroplacental haematoma Post-partum haemorrhage Premature delivery Blood samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women attending the emergency room and/or hospitalised or followed for: * Spontaneous and/or repeated miscarriage * Foetal death * Pre-eclampsia * Retroplacental haematoma * Post-partum haemorrhage * Premature delivery
Key inclusion criteria (9 listed)
- Spontaneous and/or repeated miscarriage
- Foetal death
- Pre-eclampsia
- Retroplacental haematoma
- Post-partum haemorrhage
Key exclusion criteria (1 listed)
- normal pregnancy
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 |
|---|---|---|
| blood samplesfor the determination of thyroid hormones (TSH, FT3, FT4 ) and antibodies against the thyroid (anti TPO antibodies and anti thyroglobulin) | Biological | women |
Primary outcome
Prevalence of thyroid dysfunction
Time frame: Day 0
Estimate the overall and individual prevalence of thyroid dysfunction (hypothyroidism, hyperthyroidism and thyroid autoimmunity) in patients with obstetrical accident
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
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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.
Rachel DESAILLOUD, MD, PhD principal investigator
CHU Amiens
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 Pregnancy, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 9 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: withdrawn, as of the sponsor's last update on 15 Jul 2020. 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 France. 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 was withdrawn before enrolling participants, so there are no results.
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?
Prevalence of thyroid dysfunction (time frame: Day 0). 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 15 Jul 2020.