Pregnancy Complicated by HyperthyroidismNCT01528904
Maternal Autoimmune Thyroid Disease and Fetal Thyroxin
An observational study of Pregnancy Complicated by Hyperthyroidism and Hypothyroidism in Pregnancy, run by University of Belgrade at 1 site in Serbia.
Trial summary
The purpose of this trial is to correlate fetal thyroid hormones from fetal cord blood with clinical (maternal antithyroid drug dose and antithyroid antibodies) and ultrasound (US) parameters of fetal thyroid function from pregnant mothers with autoimmune thyroid disease (AITD). Read more about this study
- Who is it for?
- Ages 23 to 45 years, women only
- Conditions the study is for
- Pregnancy Complicated by Hyperthyroidism, Hypothyroidism in Pregnancy
- How many people
- 83 participants
- Where
- 1 siteSerbia
- Study dates
- Jan 2001to Jun 2011
- 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 23 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Groups are selected from State tertiary referral centre for Gynecology and Obstetrics
Who may be able to join
- Autoimmune hyper or hypothyroidism, diagnosed by an endocrinologist, treated, based on clinical and laboratory tests and ultrasound thyroid examination.
- Patients were included if they were seen by gynecologist at Clinic for Gynecology up until 20th week of gestation and not later.
- 20 healthy pregnant women in control group were directed for cordocentesis due to age.
Who cannot join
- Any other chronic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fetal Thyroid Hormones Concentration In Hyperthyroid or Hypothyroid Pregnant Women
The purpose of this trial is to correlate fetal thyroid hormones from fetal cord blood with clinical (maternal antithyroid drug dose and antithyroid antibodies) and ultrasound (US) parameters of fetal thyroid function from pregnant mothers with autoimmune thyroid disease (AITD).
Read the detailed description
Maternal hyperthyroidism in pregnancy is complicated with hypertension, preeclampsia, heart failure, thyroid storm, preterm labor and stillbirth, while the fetus suffers from intrauterine growth retardation (IUGR), goiter; neonatal prematurity and low birth weight.
Maternal hypothyroidism is seen in 2 % of pregnancies. Risks are higher for preeclampsia, postpartum hemorrhage, miscarriage, stillbirth, preterm birth and lower IQ score.
Thyroid stimulating hormone (TSH) receptor antibodies, antithyroid drugs and iodine pass to the fetus. So the fetus may also become a patient. Monitoring fetal growth, fetal heart rate (tachycardia is a late sign of fetal hyperthyroidism), bone maturation and the size of the fetal thyroid by ultrasound are important parameters for the assessment of transfer of hyperthyroidism from mother to the fetus
Patients follow up:
After inclusion into the study, thyroid function tests (fT4, TSH), and auto-antibodies assessment (anti TPO, TRAK) were performed once every two months in mothers with AITD, and from the 24th week of gestation monthly. Treatment was adjusted accordingly. Ultrasound for fetal size, morphology and fetal heart rate (FHR) was performed once in two months, and from the 24th week of gestation, monthly. The fetal biophysical profile score was determined weekly from the 30th week of gestation. The single centre design was chosen: all fetal sonograms were performed by the same gynecologist. Cardiotocography was performed once weekly from the 30th week of gestation.
Study design:
Fetal and maternal free thyroxin (fT4) and TSH, thyroid antibodies in mothers and fetal ultrasound (fetal size, morphology and fetal heart rate) were determined at the same time, once, from 22nd to 33rd weeks of gestation.
Procedure: Cordocentesis (Cordocentesis is a highly specialized prenatal test in which a fetal blood sample is removed from the umbilical cord and tested for genetic problems, hormones or infections. Cordocentesis can be done at 18 weeks of pregnancy or later). Fetal fT4 and TSH were measured from cord blood samples. Healthy pregnant subjects were directed for cordocentesis for karyotype analysis due to age (missed previous procedures for karyotyping).
The diagnosis of fetal hypo or hyperthyroidism was established taking into account fT4 concentrations according to the nomograms Thorpee-Beeston et al., 1996, 1991.
When fetal hyperthyroidism is diagnosed, antithyroid drugs given to the mother are administered or adjusted. When fetal hypothyroidism is diagnosed, then the possibility of intraamniotic thyroxin application is discussed with the mother.
- Keywords
- pregnancy, autoimmune thyroid disease, fetal thyroid hormones, antithyroid antibodies, ultrasound parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hyperthyroid pregnant women | hyperthyroidism diagnosed and treated by an endocrinologist, based on clinical and laboratory tests and ultrasound thyroid examination. | |
| Hypothyroid pregnant women | hypothyroidism diagnosed and treated by an endocrinologist, based on clinical and laboratory tests and ultrasound thyroid examination | |
| Healthy pregnant women | uncomplicated pregnancies in healthy women, older then 35 years, directed for cordocentesis due to age, because of missed karyotyping in previous period of pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal free thyroxin
Measured: 24th to 32nd week of gestation
Secondary outcomes (3)
fetal ultrasound parameters
at the same time as fetal free thyroxin sampling
Measured: 24th to 32nd week of gestation
maternal antithyroid antibodies
sampled at the same time as the fetal free thyroxin
Measured: 24th to 32nd week of gestation
dose of maternal antithyroid medication (ATD)
recorded at the same time as the fetal sampling for free thyroxin
Measured: 24th to 32nd week of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startJan 2001
- Primary completionMar 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy Complicated by HyperthyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Svetlana Spremovic Radjenovic, University of Belgrade
- Investigators
- Svetlana Spremovic-Radjenovic, MD PhD, Principal investigator, Medical School of the University of Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01528904
- Sponsor's protocol ID
- 318/VII-4/3 3186
- Status last verified
- Feb 2012
- First submitted
- 12 Jan 2012
- Last updated
- 8 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Abalovich M, Amino N, Barbour LA, Cobin RH, De Groot LJ, Glinoer D, Mandel SJ, Stagnaro-Green A. Management of thyroid dysfunction during pregnancy and postpartum: an Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2007 Aug;92(8 Suppl):S1-47. doi: 10.1210/jc.2007-0141.
PubMed 17948378
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Thyroid Hormones Concentration In Hyperthyroid or Hypothyroid Pregnant Women
- ClinicalTrials.gov ID
- NCT01528904
- Acronym / sponsor ID
- 318/VII-4/3 3186
- Keywords
- pregnancy, autoimmune thyroid disease, fetal thyroid hormones, antithyroid antibodies, ultrasound parameters
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- Jan 2001
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 8 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to correlate fetal thyroid hormones from fetal cord blood with clinical (maternal antithyroid drug dose and antithyroid antibodies) and ultrasound (US) parameters of fetal thyroid function from pregnant mothers with autoimmune thyroid disease (AITD).
Detailed description
Maternal hyperthyroidism in pregnancy is complicated with hypertension, preeclampsia, heart failure, thyroid storm, preterm labor and stillbirth, while the fetus suffers from intrauterine growth retardation (IUGR), goiter; neonatal prematurity and low birth weight.
Maternal hypothyroidism is seen in 2 % of pregnancies. Risks are higher for preeclampsia, postpartum hemorrhage, miscarriage, stillbirth, preterm birth and lower IQ score.
Thyroid stimulating hormone (TSH) receptor antibodies, antithyroid drugs and iodine pass to the fetus. So the fetus may also become a patient. Monitoring fetal growth, fetal heart rate (tachycardia is a late sign of fetal hyperthyroidism), bone maturation and the size of the fetal thyroid by ultrasound are important parameters for the assessment of transfer of hyperthyroidism from mother to the fetus
Patients follow up:
After inclusion into the study, thyroid function tests (fT4, TSH), and auto-antibodies assessment (anti TPO, TRAK) were performed once every two months in mothers with AITD, and from the 24th week of gestation monthly. Treatment was adjusted accordingly. Ultrasound for fetal size, morphology and fetal heart rate (FHR) was performed once in two months, and from the 24th week of gestation, monthly. The fetal biophysical profile score was determined weekly from the 30th week of gestation. The single centre design was chosen: all fetal sonograms were performed by the same gynecologist. Cardiotocography was performed once weekly from the 30th week of gestation.
Study design:
Fetal and maternal free thyroxin (fT4) and TSH, thyroid antibodies in mothers and fetal ultrasound (fetal size, morphology and fetal heart rate) were determined at the same time, once, from 22nd to 33rd weeks of gestation.
Procedure: Cordocentesis (Cordocentesis is a highly specialized prenatal test in which a fetal blood sample is removed from the umbilical cord and tested for genetic problems, hormones or infections. Cordocentesis can be done at 18 weeks of pregnancy or later). Fetal fT4 and TSH were measured from cord blood samples. Healthy pregnant subjects were directed for cordocentesis for karyotype analysis due to age (missed previous procedures for karyotyping).
The diagnosis of fetal hypo or hyperthyroidism was established taking into account fT4 concentrations according to the nomograms Thorpee-Beeston et al., 1996, 1991.
When fetal hyperthyroidism is diagnosed, antithyroid drugs given to the mother are administered or adjusted. When fetal hypothyroidism is diagnosed, then the possibility of intraamniotic thyroxin application is discussed with the mother.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hyperthyroid pregnant women | – | –hyperthyroidism diagnosed and treated by an endocrinologist, based on clinical and laboratory tests and ultrasound thyroid examination. |
| Hypothyroid pregnant women | – | –hypothyroidism diagnosed and treated by an endocrinologist, based on clinical and laboratory tests and ultrasound thyroid examination |
| Healthy pregnant women | – | –uncomplicated pregnancies in healthy women, older then 35 years, directed for cordocentesis due to age, because of missed karyotyping in previous period of pregnancy |
Who may qualify
- Ages
- 23 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Groups are selected from State tertiary referral centre for Gynecology and Obstetrics
Key inclusion criteria (3 listed)
- Autoimmune hyper or hypothyroidism, diagnosed by an endocrinologist, treated, based on clinical and laboratory tests and ultrasound thyroid examination.
- Patients were included if they were seen by gynecologist at Clinic for Gynecology up until 20th week of gestation and not later.
- 20 healthy pregnant women in control group were directed for cordocentesis due to age.
Key exclusion criteria (1 listed)
- Any other chronic diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fetal free thyroxin
Time frame: 24th to 32nd week of gestation
3 secondary outcomes
fetal ultrasound parameters
Time frame: 24th to 32nd week of gestation
maternal antithyroid antibodies
Time frame: 24th to 32nd week of gestation
dose of maternal antithyroid medication (ATD)
Time frame: 24th to 32nd week of gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2012.
- Background: PubMed 17948378Abalovich M, Amino N, Barbour LA, Cobin RH, De Groot LJ, Glinoer D, Mandel SJ, Stagnaro-Green A. Management of thyroid dysfunction during pregnancy and postpartum: an Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2007 Aug;92(8 Suppl):S1-47. doi: 10.1210/jc.2007-0141.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Svetlana Spremovic-Radjenovic, MD PhD principal investigator
Medical School of the University of Belgrade
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Complicated by Hyperthyroidism and Hypothyroidism in Pregnancy, run by University of Belgrade at 1 site in Serbia.
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 3 inclusion and 1 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 8 Feb 2012. 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 Serbia. 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?
Fetal free thyroxin (time frame: 24th to 32nd week of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01528904, which also lists 1 linked publication.
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 8 Feb 2012.