Thyroid Dysfunction and Obstetric Complications

NCT02815501 | Withdrawn

• 1 other identifier: PI11-PR-DESAILLOUD 2
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy

Keywords

Thyroid dysfunction; obstetric complications

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Biological: blood samples

Interventions

blood samples BIOLOGICAL

for the determination of thyroid hormones (TSH, FT3, FT4 ) and antibodies against the thyroid (anti TPO antibodies and anti thyroglobulin)

women

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• normal pregnancy

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples for a laboratory work-up and anti-thyroid antibodies.

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Rachel DESAILLOUD, MD, PhD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: June 28, 2016
• Study Start: March 1, 2012
• Primary Completion: October 26, 2017
• Study Completion: October 26, 2017
• Last Updated: July 15, 2020

Record last verified: 2020-07

Locations

FR (1)