Thyroid Dysfunction and Obstetric Complications

NCT ID: NCT02815501

Last Updated: 2020-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-01

Study Completion Date

2017-10-26

Brief Summary

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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.

Detailed Description

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Conditions

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Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

blood samples

Intervention Type BIOLOGICAL

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

Interventions

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blood samples

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rachel DESAILLOUD, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

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CHU Amiens

Amiens, , France

Site Status

Countries

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France

Other Identifiers

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PI11-PR-DESAILLOUD 2

Identifier Type: -

Identifier Source: org_study_id

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