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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01301768
Other study ID # PI071265
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date November 2008
Est. completion date December 2011

Study information

Verified date October 2018
Source Jordi Gol i Gurina Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the effectiveness of individual education versus group education about dietary habits and iodine supplementation to decrease iodine deficiency in pregnant women


Description:

BACKGROUND: It is a priority to achieve an adequate nutritional status of iodine during pregnancy since iodine deficiency in this population may have repercussions on the mother during both gestation and post partum as well as on the foetus, the neonate and the child at different ages. According to the WHO, iodine deficiency is the most frequent cause of mental retardation and irrreversible cerebral lesions around the world. However, few studies have been published on the nutritional status of iodine in the pregnant population within the Primary Care setting, a health care level which plays an essential role in the education and control of pregnant women.

AIMS: 1.- To know the hygiene-dietetic habits related to the intake of foods rich in iodine and smoking during pregnancy. 2.- To determine the prevalence of iodine deficiency and the factors associated with its appearance during pregnancy.

METHODS/DESIGN: We will perform a cluster randomised, controlled, multicentre trial. Randomisation unit: Primary Care Team. Study population: 898 pregnant women over the age of 17 years attending consultation to a midwife during the first trimester of pregnancy in the participating primary care centres. Outcome measures: consumption of iodine-rich foods and iodine deficiency. Points of assessment: each trimester of the gestation. Intervention: group education during the first trimester of gestation on healthy hygiene-dietetic habits and the importance of an adequate iodine nutritional status. Statistical analysis: descriptive analysis of all variables will be performed as well as multilevel logistic regression. All analyses will be done carried out on an intention to treat basis and will be fitted for potential confounding factors and variables of clinical importance.

DISCUSSION: Evidence of generalised iodine deficiency during pregnancy could lead to the promotion of interventions of prevention such as how to improve and intensify health care educational programmes for pregnant women.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Pregnant Women in the first trimester

- Over the age of 17

- Receive routine care in their respective health center

Exclusion Criteria:

- Pregnant women who are in the second or third trimester.

- Pregnant women with diagnostic of thyroid disease.

- Pregnant women who do not have a phone.

- Pregnant women with communication difficulties (cognitive or sensory deterioration, language barrier).

- Pregnant women who do not consent to participate in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Group Education
Group educational workshops about dietary habits in the first trimester because it is when organogenesis occurs and therefore when the iodine deficiency in the mother is an important risk in the development of the fetal central nervous system.

Locations

Country Name City State
Spain IDIAP Jordi Gol Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Jordi Gol i Gurina Foundation

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Iodine deficiency Urinary iodine excretion below 150 µg/l 36 weeks of pregnancy
Primary Iodine deficiency Urinari iodine excretion below 150 µg/l 24 weeks of pregnancy
Secondary Date of birth At baseline
Secondary Smoking Categories: yes / no First trimester of pregnancy (14 weeks)
Secondary Iodized salt consumption Categories: yes / no First trimester of pregnancy (14 weeks)
Secondary Iodine supplementation consumption Categories: yes / no First trimester of pregnancy
Secondary Education Level Categories: can not read or write, incomplete primary, completed primary, completed secondary and university At baseline
Secondary Ethnicity At baseline
Secondary Number of pregnancies finishes At baseline
Secondary Number of premature births At baseline
Secondary Number of abortions At baseline
Secondary Number of live births At baseline
Secondary Trimester of pregnancy Categories: yes / no First trimester of pregnancy
Secondary Glasses of milk a day (number) First trimester of pregnancy
Secondary Yogurt per week (number) First trimester of pregnancy
Secondary Servings of cheese per week (number) First trimester of pregnancy
Secondary Usual preparation of vegetables Categories: raw, fried, grilled / baked, steamed and boiled First trimester of pregnancy
Secondary Use of water to boil vegetables Categories: yes / no First trimester of pregnancy
Secondary Vegetable consumption per week (number) First trimester of pregnancy
Secondary Fish consumption per week (number) First trimester of pregnancy
Secondary Usual preparation of fish Categories: raw, fried, grilled / baked, steamed and boiled First trimester of pregnancy
Secondary Canned tuna consumption per week (number) First trimester of pregnancy
Secondary Canned sardines consumption per week (number) First trimester of pregnancy
Secondary Meat consumption per week (number) First trimester of pregnancy
Secondary Cold meat consumption per week (number) First trimester of pregnancy
Secondary Eggs consumption per week (number) First trimester or pregnancy
Secondary Fruit consumption per week (number) First trimester of pregnancy
Secondary Nuts consumption per week (number) First trimester of pregnancy
Secondary Potassium iodide consumption First trimester of pregnancy
Secondary Smoking Categories: yes / no Second trimester of pregnancy (wk 15-wk 27 )
Secondary Smoking Categories: yes / no Third trimester of pregnancy (wk28-wk40)
Secondary Iodized salt consumption Categories: yes / no Second trimester of pregnancy
Secondary Iodized salt consumption Categories: yes / no Third trimester of pregnancy
Secondary Iodine supplementation consumption Categories: yes / no Second trimester of pregnancy
Secondary Iodine supplementation consumption Categories: yes / no Third trimester of pregnancy
Secondary Trimester of pregnancy Categories: yes / no Second trimester of pregnancy
Secondary Trimester of pregnancy Categories: yes / no Third trimester of pregnancy
Secondary Glasses of milk a day (number) Second trimester of pregnancy
Secondary Glasses of milk a day (number) Third trimester of pregnancy
Secondary Yogurt per week (number) Second trimester of pregnancy
Secondary Yogurt per week (number) Third trimester of pregnancy
Secondary Servings of cheese per week (number) Second trimester of pregnancy
Secondary Servings of cheese per week (number) Third trimester of pregnancy
Secondary Usual preparation of vegetables Categories: raw, fried, grilled / baked, steamed and boiled Second trimester of pregnancy
Secondary Usual preparation of vegetables Categories: raw, fried, grilled / baked, steamed and boiled Third trimester of pregnancy
Secondary Use of water to boil vegetables Categories: yes / no Second trimester of pregnancy
Secondary Use of water to boil vegetables Categories: yes / no Third trimester of pregnancy
Secondary Vegetable consumption per week (number) Second trimester of pregnancy
Secondary Vegetable consumption per week (number) Third trimester of pregnancy
Secondary Fish consumption per week (number) Second trimester of pregnancy
Secondary Fish consumption per week (number) Third trimester of pregnancy
Secondary Usual preparation of fish Categories: raw, fried, grilled / baked, steamed and boiled Second trimester of pregnancy
Secondary Usual preparation of fish Categories: raw, fried, grilled / baked, steamed and boiled Third trimester of pregnancy
Secondary Canned tuna consumption per week (number) Second trimester of pregnancy
Secondary Canned tuna consumption per week (number) Third trimester of pregnancy
Secondary Canned sardines consumption per week (number) Second trimester of pregnancy
Secondary Canned sardines consumption per week (number) Third trimester of pregnancy
Secondary Meat consumption per week (number) Second trimester of pregnancy
Secondary Meat consumption per week (number) Third trimester of pregnancy
Secondary Cold meat consumption per week (number) Second trimester of pregnancy
Secondary Cold meat consumption per week (number) Third trimester of pregnancy
Secondary Eggs consumption per week (number) Second trimester or pregnancy
Secondary Eggs consumption per week (number) Third trimester or pregnancy
Secondary Fruit consumption per week (number) Second trimester of pregnancy
Secondary Fruit consumption per week (number) Third trimester of pregnancy
Secondary Nuts consumption per week (number) Second trimester of pregnancy
Secondary Nuts consumption per week (number) Third trimester of pregnancy
Secondary Potassium iodide consumption Second trimester of pregnancy
Secondary Potassium iodide consumption Third trimester of pregnancy
Secondary Iodine deficiency Urinary iodine excretion below 150 µg/l Baseline at first trimester of pregnancy
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