Thyroid Dysfunction and Obstetric Complications (TDOC)

July 13, 2020 updated by: Centre Hospitalier Universitaire, Amiens

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • CHU Amiens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
for the determination of thyroid hormones (TSH, FT3, FT4 ) and antibodies against the thyroid (anti TPO antibodies and anti thyroglobulin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Investigators

  • Principal Investigator: Rachel DESAILLOUD, MD, PhD, CHU Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2012

Primary Completion (Actual)

October 26, 2017

Study Completion (Actual)

October 26, 2017

Study Registration Dates

First Submitted

June 24, 2016

First Submitted That Met QC Criteria

June 27, 2016

First Posted (Estimate)

June 28, 2016

Study Record Updates

Last Update Posted (Actual)

July 15, 2020

Last Update Submitted That Met QC Criteria

July 13, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI11-PR-DESAILLOUD 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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