Pregnancy Complications Clinical Trial
— GravThyrOfficial title:
Relation Between Thyroid Hormone Stimulated Mitochondrial Function and Spontaneous Abortion and Complications of Pregnancy in Subclinical Hypothyroidism
NCT number | NCT01335802 |
Other study ID # | SJ-177 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2010 |
Est. completion date | December 2016 |
Verified date | March 2020 |
Source | Naestved Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 113 |
Est. completion date | December 2016 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Naestved Hospital | Naestved |
Lead Sponsor | Collaborator |
---|---|
Naestved Hospital | University of Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Mitochondrial dysfunction | Measure by flow cytometry | 1 year |
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