Thyroid Function Throughout Pregnancy With and Without Iodine Supplementation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00831402
First received: January 28, 2009
Last updated: March 23, 2012
Last verified: February 2009
  Purpose

Goals of the study :

  1. To study maternal thyroid function during pregnancy with or without supplementation with pregnancy tablets fortified with iodine
  2. To establish reference values of thyroid function at different stages of pregnancy (3 trimesters)
  3. To precise screening strategy of iodine deficiency in our population and suggest recommendation for its prevention.

Condition Intervention
Pregnancy
Dietary Supplement: Oligobs Maxiode
Dietary Supplement: controll group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Assessment of Thyroid Function Throughout Pregnancy With and Without Iodine Supplementation

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • • Intra individual variation of maternal thyroglobulin between the first trimester and the delivery • And cord blood thyroglobulin With comparison of the 2 groups (control and supplementation with iodine) [ Time Frame: Every 3 months up to the give birth, the day of a give birth, and after three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of control and treated groups for : • Frequence of miscarriage, duration of gestation, birth weight, APGAR, neonatal complications, Maternal thyroid function, Frequency of post partum thyroiditis,Cord blood thyroid function [ Time Frame: Every 3 months up to the give birth, the day of a give birth, and after three months ] [ Designated as safety issue: No ]

Enrollment: 111
Study Start Date: June 2007
Study Completion Date: August 2008
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Arm without iodized vitamin (VITAMIN OLIGOBS PREGNANCY)
50 women will be studied in the absence of iodized supplémentation(natural history of function thyroïdienne in the course of the pregnancy and in the post partum)
Dietary Supplement: controll group
50 women will be studied in the absence of iodized supplémentation(natural history of function thyroïdienne in the course of the pregnancy and in the post partum)
Active Comparator: Arm with iodized vitamin
The 50 women will be follow up with a supplémentation iodized by vitamins of pregnancy strengthened in iodin everything in the course of the pregnancy and during the 3 months post partum (Oligobs Maxiode, 150 mcg / of iodizes, is 2cp a day)
Dietary Supplement: Oligobs Maxiode
The 50 women will be follow up with a supplémentation iodized by vitamins of pregnancy strengthened in iodin everything in the course of the pregnancy and during the 3 months post partum (Oligobs Maxiode, 150 mcg / of iodizes, is 2cp a day)

Detailed Description:

Overt maternal hypothyroidism and/or iodine deficiency during pregnancy are linked to mental retardation in their offspring. Iodine deficiency may lead to maternal hypothyroxinemia, and even mild hypothyroidism in predisposed women. Indeed, thyroid hormones are of paramount importance for fetal brain development. During the first trimester of pregnancy, the only thyroid hormones available to the fetus are from maternal origin. Later in pregnancy, fetal thyroid progressively starts producing thyroid hormone, providing that maternal iodine status is adequate (≥200-250 mcg/day). It has been shown recently that mild maternal hypothyroidism may be responsible for discrete neuropsychological impairment in her child, implying a potential benefit for early screening and care during pregnancy. Furthermore, iodine deficiency is extremely common in our area (Brucker-Davis et al 2004). However, there is no official recommendation for screening and prevention, as for gestational diabetes for example.

We propose to study healthy pregnant women, screened before 12 weeks of gestation and without thyroid disease. They will be randomized in 2 groups and will therefore take pregnancy tablets, iodine fortified or not (Oligobs Maxiode -150 mcg/j of iodine, vs Oligobs grossesse), in addition to appropriate nutritional advice. Their longitudinal study will involve:

  1. Evolution of thyroid function parameters in the 2 groups, with comparison of maternal thyroid volumes, maternal thyroid hormones levels and cord blood parameters, including thyroglobulin, during pregnancy and in postpartum.
  2. Establishment of reference ranges for thyroid parameters for each trimester of pregnancy.

This public health project rests on our expertise in the care of pregnancies with maternal endocrine and metabolic disease (Hieronimus et al 2003-2005) and on a close collaboration of our Departments within the Pole "Mother-Child", conveniently located at the same hospital. It will allow us to precise iodine deficiency screening and prevention in our population and to structure and optimize the care for women with thyroid disease screened early in pregnancy (opening of a specific clinic), in order to improve maternal and fetal prognosis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All women follow-up in the three months of the pregnancy in the CHU de Nice
  • Maternal thyroid function is between and 0.1<TSH<2.5 mUI/l, 23>T4L>12 pmol/l
  • Person over 18
  • Signed lit Consent
  • Give birth in the CHU of Nice

Exclusion Criteria:

  • Allergy known in iodine
  • Iodized surcharge defined by an iodurie> 400 mcg / l
  • Catch of ongoing iodized vitamins of pregnancy
  • Participation in another research protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831402

Locations
France
CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez
Nice, Alpes-Maritimes, France, 06001
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Françoise Dr BRUCKER-DAVIS, PH CHU de Nice - Service d'endocrinologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT00831402     History of Changes
Other Study ID Numbers: 05-PHRC-03
Study First Received: January 28, 2009
Last Updated: March 23, 2012
Health Authority: France: Direction Générale de la Santé

Keywords provided by Centre Hospitalier Universitaire de Nice:
woman

Additional relevant MeSH terms:
Iodine
Vitamins
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 23, 2014