Thyroid Dysfunction and Obstetric Complications

Pregnancy Clinical Trial

— TDOC  

Official title:

Thyroid Dysfunction and Obstetric Complications

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02815501
• Other study ID #: PI11-PR-DESAILLOUD 2
• Status: Withdrawn
• Start date: March 1, 2012
• Est. completion date: October 26, 2017

Study information

• Verified date: July 2020
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 26, 2017
• Est. primary completion date: October 26, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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 consent to participate in the study.

• Assessment of these women will include blood samples for a laboratory work-up and anti-thyroid antibodies.

Exclusion Criteria:

• normal pregnancy

Related Conditions & MeSH terms

• Pregnancy
• Thyroid Diseases

Intervention

Biological:
• blood samples
for the determination of thyroid hormones (TSH, FT3, FT4 ) and antibodies against the thyroid (anti TPO antibodies and anti thyroglobulin)

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of thyroid dysfunction	Estimate the overall and individual prevalence of thyroid dysfunction (hypothyroidism, hyperthyroidism and thyroid autoimmunity) in patients with obstetrical accident	Day 0