The study protocol was approved by the French National Agency for Medicines and Health Products Safety (ANSM) and by the ethics committee of Agneres University Hospital (Institutional Review Board; Agreement of Department of Health and Human Services No. RCB : 2020-A02570-39) Comprehensive information on the study was provided to each patient on a form printed specifically for this purpose, the study received a registration on the clinical traial.gouve system with the number: NCT04683211
Main and secondary objectives:
We wish to examine whether in women having a pregnancy benefiting from a personalized follow-up linked to a diagnosis of gestational diabetes, iodine supplementation is implemented according to WHO recommendations, ie 250 μg / day. Primary Evaluation Criterion: Iodic supplementation prescribed in μg / d
Secondary objectives: evaluation of iodic supplementation according to prescriber (midwife versus general practician or gynecologist). Secondary evaluation criterion odic supplementation prescribed in μg / day by midwive, iodic supplementation prescribed in μg / prescribed by the general practitioner and iodic supplementation prescribed in μg / day by gynecologists.
Inclusion criteria: Pregnant woman with gestational diabetes confirmed by un abnormal fasting glucose or by oral hyperglycemia test, age ≥ 18 years, subject informed of the study and not having opposed it. Non-inclusion criteria: Already known thyroid pathology.
Key Data Collected and the outcome of the study
Upon arrival at the reception consultation for the management of gestational diabetes, the information note will be given to the patient. During the consultation, the investigator will explain the study and obtain the patient's agreement to participate. The questionnaire will then be given to the patient.
There are no plans to follow up patients in this study. Participation consists of completing the questionnaire.
Data collected: The participants will answer to a questionary included the following questions: The term of pregnancy (in weeks), the parity (number of pregnancies), if the participants have a chronic pathology? If so, which one? which treatment? if the patient in known to have a pathology of the thyroid gland? If so, which therapy. Have the participant received a prescription for iodine supplementation since the start of pregnancy, If so, which one, for how long, at what dose. If there is iodic supplementation, who prescribed the prescription (midwife, attending physician, gynecologist. Are the lady receiving folic acid? During your previous pregnancies, did you receive vitamin supplementation? If yes which one?
Statistical justification for the sample size
We hypothesize that one in 2 patients receives iodine supplementation at 250μg / d. The number of patients is therefore 97 patients.
Description of statistical methods
The descriptive analysis will include for each quantitative parameter: mean, standard deviation, median, interquartiles, minimum, maximum. The qualitative parameters will be expressed by their number and corresponding percentage.
If p is the expected percentage, its confidence interval, considered at 20%, is: p + - 1.96 * square root of ((p * (1-p) / n)
If d is the distance between the estimate of the percentage and the bounds of its confidence interval, we must solve the equation:
d = 1.96 * square root of ((p * (1-p) / n)
=> n = 1.96 ^ 2 * p * (1-p) /d^2.= 97 patients
The analysis will be performed using R software (R version 3.5.0 (2018-04-23) © 2018 The R Foundation for Statistical Computing).