NCT02017080

Brief Summary

Non invasive methods: maternal antithyroid antibodies and ultrasound measurement of the fetal thyroid gland could be an important tool for detecting fetal thyroid dysfunction in mothers with autoimmune thyroid disease.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 20, 2013

Completed
12 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

January 6, 2015

Status Verified

January 1, 2015

Enrollment Period

5.9 years

First QC Date

December 15, 2013

Last Update Submit

January 5, 2015

Conditions

Pregnancy Complicated by HyperthyroidismHypothyroidism in Pregnancy

Keywords

fetal thyroid ultrasoundfetal fT4antithyroid antibodiespregnancyautoimmune thyroid disease

Outcome Measures

Primary Outcomes (1)

  • Fetal thyroid size measured by ultrasonography

    28th week of gestation

Secondary Outcomes (5)

  • Fetal fT4

    28th week of gestation

  • Fetal antithyroid antibodies

    28th week of gestation

  • Maternal fT4

    28th week of gestation

  • Maternal TSH

    28th week of gestation

  • Maternal antithyroid antibodies

    28th week of gestation

Study Arms (3)

Hyperthyroid pregnant women

Autoimmune hyperthyroidism diagnosed and treated by an endocrinologist, based on clinical and laboratory tests and ultrasound clinical examination

Hypothyroid pregnant women

Autoimmune hypothyroidism diagnosed and treated by an endocrinologist, based on clinical and laboratory tests and ultrasound thyroid examination

Healthy pregnant women

Euthyroid women with uncomplicated pregnancies, with antithyroid antibodies within reference ranges

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Groups are selected from State tertiary referral centre for Gynecology and Obstetrics

You may qualify if:

  • Pregnant women diagnosed and treated for autoimmune hyper or hypothyroidism: - Disease diagnosed by an endocrinologist, based on clinical and laboratory tests and ultrasound thyroid examination.
  • All of the hyper or hypothyroid women have to be positive for one or both thyroid antibodies when entering the study.
  • Patients with autoimmune thyroid disease will be included into the study in the first half of pregnancy, but not later than 20th weeks of gestation
  • For the pregnant women in control group:
  • if they are euthyroid, with antithyroid antibodies within reference range, healthy and have uncomplicated pregnancy

You may not qualify if:

  • all the patients whose pregnancies resulted from assisted reproductive technologies will be excluded from the study.
  • mothers from the control group will be excluded, if the neonate have abnormal thyroid function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic for Gynecology and Obstetrics , Clinical Center of Serbia

Belgrade, 11000, Serbia

RECRUITING

Related Publications (3)

  • Achiron R, Rotstein Z, Lipitz S, Karasik A, Seidman DS. The development of the foetal thyroid: in utero ultrasonographic measurements. Clin Endocrinol (Oxf). 1998 Mar;48(3):259-64. doi: 10.1046/j.1365-2265.1998.00388.x.

    PMID: 9578813BACKGROUND

  • Ranzini AC, Ananth CV, Smulian JC, Kung M, Limbachia A, Vintzileos AM. Ultrasonography of the fetal thyroid: nomograms based on biparietal diameter and gestational age. J Ultrasound Med. 2001 Jun;20(6):613-7. doi: 10.7863/jum.2001.20.6.613.

    PMID: 11400935BACKGROUND

  • Luton D, Le Gac I, Vuillard E, Castanet M, Guibourdenche J, Noel M, Toubert ME, Leger J, Boissinot C, Schlageter MH, Garel C, Tebeka B, Oury JF, Czernichow P, Polak M. Management of Graves' disease during pregnancy: the key role of fetal thyroid gland monitoring. J Clin Endocrinol Metab. 2005 Nov;90(11):6093-8. doi: 10.1210/jc.2004-2555. Epub 2005 Aug 23.

    PMID: 16118343RESULT

Study Officials

  • Svetlana S Spremovic- Radjenovic, MD PhD

    Medical School of the University of Belgrade

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Svetlana S Spremovic- Radjenovic, MD PhD

CONTACT

+38163696246spremovics@gmail.com

Aleksandra M Gudovic, MD PhD

CONTACT

+381641642631sasagudovic@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor, Gynecologyst and Obstetrician, sibspecialist in endocrinology

Study Record Dates

First Submitted

December 15, 2013

First Posted

December 20, 2013

Study Start

January 1, 2014

Primary Completion

December 1, 2019

Study Completion

January 1, 2020

Last Updated

January 6, 2015

Record last verified: 2015-01

Locations

SE(1)