NCT01335802

Brief Summary

Studies have demonstrated a relationship between subclinical hypothyroidism and obstetrics complications like preterm delivery, pre-eclampsia, placental abruption and stillbirth. Subclinical hypothyroidism and positive thyroperoxidase antibodies (TPOab) may increase the risk of early spontaneous abortion before 12 weeks of gestation. But there is not a consensus if the prevalence of TPOab should be treated before and during pregnancy when the level of thyroid-stimulating hormone (TSH) is normal. Thyroid hormones are regulators of the mitochondrial activity and our research group has previously shown that subclinical hypothyroidism affects mitochondrial activity. The hypothesis: Subclinical hypothyroidism causes early spontaneous abortion and or complications in pregnancy like pre-eclampsia because of mitochondrial dysfunction

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 14, 2011

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

4.9 years

First QC Date

April 11, 2011

Last Update Submit

March 17, 2020

Conditions

Abortion, SpontaneousPregnancy ComplicationsSubclinical Hypothyroidism

Keywords

Abortion, SpontaneousPre-eclampsiaGestational hypertensionPregnancy ComplicationsSubclinical hypothyroidismThyroperoxidase antibodies (TPOab)Mitochondrial dysfunction

Outcome Measures

Primary Outcomes (2)

  • Subclinical hypothyroidism

    When the women participate the General Suburban Population Study (GeSuS) s-TSH are estimated. The women will be invited by letter if they match the inclusion criteria. There will only be one visit at the hospital for new bloodsample (flow cytometry) and measurement of oxygen consumption.

    1 year

  • Pre-eclampsia

    Does pregnant women with subclinical hypothyroidism have mitochondrial dysfunction which could explain the higher frequency of gestational hypertension and pre-eclampsia? Pregnant women who consult the department of obstetrics are invited to participate (interview and a blood sample).

    1 year

Secondary Outcomes (1)

  • Mitochondrial dysfunction

    1 year

Study Arms (2)

Subclinical hypothyroidim

Women having subclinical hypothyroidism and/or TPOab-positive.

Controls

Women having normal levels of TSH and TPOab-negative.

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Part 2: Fertile women from the General Suburban Population Study in Naestved (GeSuS), Region Zealand, Denmark. Part 3: Pregnant women (GA\>27) who are consulting the department of obstetrics, Naestved Hospital.

You may qualify if:

  • Women who had experienced a minimum of one early spontaneous abortion and between 20 and 50 years old: 80 women who have subclinical hypothyroidism defined as raised serum concentrations of TSH \> 3,4 mU/l and normal levels of free T4 and T3 or TPOab-positive and 80 women who have normal levels of TSH and TPOab-negative.

You may not qualify if:

  • Women with metabolic disease, diabetes or psychiatric disease.
  • Women using medicine against hypo- or hyperthyroidism.
  • Women who never give birth or age more than 50 years.
  • Part 3:
  • Pregnant women (3rd trimester)
  • Women with metabolic disease, diabetes or psychiatric disease.
  • Women using medicine against hypo- or hyperthyroidism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Naestved Hospital

Næstved, 4700, Denmark

Location

MeSH Terms

Conditions

Abortion, SpontaneousPregnancy ComplicationsPre-EclampsiaHypertension, Pregnancy-InducedMitochondrial Diseases

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertensionVascular DiseasesCardiovascular DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jan Kvetny, MD, DMSc

    Department of Internal Medicine & Faculty of Health Sciences, University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 11, 2011

First Posted

April 14, 2011

Study Start

October 1, 2010

Primary Completion

September 1, 2015

Study Completion

December 1, 2016

Last Updated

March 18, 2020

Record last verified: 2020-03

Locations

DK(1)