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Abortion, SpontaneousGravThyrNCT01335802

Relation Between Subclinical Hypothyroidism and Outcome of Pregnancy

An observational study of Abortion, Spontaneous and Pregnancy Complications, run by Naestved Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Studies have demonstrated a relationship between subclinical hypothyroidism and obstetrics complications like preterm delivery, pre-eclampsia, placental abruption and stillbirth. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
How many people
113 participants
Where
1 siteDenmark
Study dates
Oct 2010to Dec 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

  • 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.
  • Pregnant women (3rd trimester)

Who cannot join

  • 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:
  • Women with metabolic disease, diabetes or psychiatric disease.
  • Women using medicine against hypo- or hyperthyroidism.

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Naestved Hospital

    Næstved, 4700

Other trials in Denmark

About this study

Official title: Relation Between Thyroid Hormone Stimulated Mitochondrial Function and Spontaneous Abortion and Complications of Pregnancy in Subclinical Hypothyroidism

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.

Read more

The hypothesis:

Subclinical hypothyroidism causes early spontaneous abortion and or complications in pregnancy like pre-eclampsia because of mitochondrial dysfunction

Read the detailed description

The aim is to estimate the relationship between SH and spontaneous abortion and/or obstetric complications because of mitochondrial dysfunction.

  1. A prospective study where data from the General Suburban Population Study in Naestved will be analyzed to measure the frequency of subclinical hypothyroidism (SH) and TPOab. SH is defined as raised serum concentrations of TSH > 3,4 mU/l and normal levels of free T4 and T3. A cut-off of 60 mU/l is used for TPOab.
  2. To estimate the relationship between SH or TPOab and early spontaneous abortion and pregnancy outcome. Inclusion of women who have experienced a minimum of one early spontaneous abortion and between 20 and 50 years old: 50 women who have SU and/or TPOab-positive and 50 women who have normal levels of TSH and TPOab-negative. The basal oxygen consumption will be measured and mitochondrial functions will be determined by flow cytometry.
  3. To estimate the prevalence of gestational hypertension and pre-eclampsia among pregnant women with subclinical hypothyroidism and estimate the mitochondrial function. A minimum of 100 pregnant women without any thyroid disease or diabetes will be included.

Early spontaneous abortion is defined as abortion before 12 weeks of gestation. Obstetrics complications are defined as pre-eclampsia (proteinuria, oedema, hypertension), pregnancy-induced hypertension, placental insufficience (IUGR) and abruption, preterm delivery and stillbirth. Those complications will be analyzed from the data of the obstetric journals.

Measurement of oxygen consumption:

Respiratory gas analysis and volume measurements were performed with a canopy connected by a triple V (flow⁄gas sensor) to an Oxycon apparatus (Jaeger Oxycon Champion, Breda, the Netherlands). The equipment was calibrated before each test to compensate for ambient conditions such as air pressure, temperature and humidity. Basal VO2 was measured after at least 6 hours fasting. Before the test the individual resting pulse was established and the participants rested for about 30 min in a chair. The test room was quiet and the lighting was subdued. The subjects were given sufficient time to become familiarized with the equipment and the procedures and the test was initiated when the resting pulse was achieved. Oxygen consumption was measured when the uptake per minute remained constant. Measurements were performed for repeated periods of 30 seconds for 20 minutes. The method for recording oxygen uptake had a within-day variation of 0.8 % and a day-to-day variation of 5.8 %.

Measurement of mitochondrial mass (MM) and mitochondrial membrane potential (MMP) by flow cytometry:

Venous blood was drawn from the patient in EDTA Vacutainer tubes. From each patient 2 samples of 100 µl of blood were processed. One unstained control tube and one stained were analyzed.

The samples to be stained were added 1 µl Pacific Blue Mouse Anti-Human anti-CD14 (BD Biosciences, Denmark) and mixed. The tubes were incubated for 30 minutes at room temperature protected from direct light and subsequently washed.

The stained cells were resuspended in 890 µl PBS and added 10 µl 1 µM MTG (MitoTracker Green FM, Invitrogen A/S, Denmark) and 100 µl 1 µM TMRM (Tetramethylrhodamine methyl ester, Invitrogen A/S, Denmark). All stock solutions were dissolved in DMSO (dimethyl sulfoxide) and working solutions were diluted in PBS. After mixing samples were incubated for 30 minutes at room temperature in the dark.

Keywords
Abortion, Spontaneous, Pre-eclampsia, Gestational hypertension, Pregnancy Complications, Subclinical hypothyroidism, Thyroperoxidase antibodies (TPOab), Mitochondrial dysfunction
Medical subject headings
Abortion, Spontaneous, Pregnancy Complications, Pre-Eclampsia, Hypertension, Pregnancy-Induced, Mitochondrial Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Genetic

    Genetic counseling

Study groups in NCT01335802
Study groupRoleWhat they receive
Subclinical hypothyroidimWomen having subclinical hypothyroidism and/or TPOab-positive.
ControlsWomen having normal levels of TSH and TPOab-negative.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year

  2. 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).

    Measured: 1 year

Secondary outcomes (1)
  1. Mitochondrial dysfunction

    Measure by flow cytometry

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2011 (estimated)
  2. Study startOct 2010
  3. Primary completionSep 2015
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01335802
Sponsor's protocol ID
SJ-177
Acronym
GravThyr
Status last verified
Mar 2020
First submitted
11 Apr 2011
Last updated
18 Mar 2020
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Abortion, Spontaneous and Pregnancy Complications, run by Naestved Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subclinical hypothyroidism (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.

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