CompletedNot Applicable

Relation Between Subclinical Hypothyroidism and Outcome of Pregnancy

Denmark113 participantsStarted 2010-10

Plain-language 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

Who can participate

Age range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Part 2: Inclusion Criteria: 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. Exclusion Criteria: * 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: Inclusion Criteria: * Pregnant women (3rd trimester) Exclusion Criteria: * Women with metabolic disease, diabetes or psychiatric disease. * Women using medicine against hypo- or hyperthyroidism.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Subclinical hypothyroidism

Timeframe: 1 year

Pre-eclampsia

Timeframe: 1 year

Trial details

NCT IDNCT01335802

SponsorNaestved Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2015-09

View on ClinicalTrials.gov More Abortion, Spontaneous trials