Description of the Study
The phases of the study are:
* PHASE 1. Recruitment of primary care nurses (PCN): the project was presented to all the PCN within the study setting to recruit midwives interested in participating. Those who were interested in collaborating signed a document of commitment to participate in the study.
* PHASE 2. Creation of the study groups (intervention-IG and non intervention-NIG) and midwife training programme:
- The randomisation unit was the PCN. Using simple randomisation the centres distributed the IG and NIG at a proportion of 1:1.
- The formation of the participating midwives was carried out on 3 centralised work days during which the develpment of the study was explained in depth and they were given instructions on correct completion of the questionnaire on hygienic-dietetic habits in both a paper and electronic format. Each professional was assigned a support investigator to clarify any doubts which may arise during the study period. The objective of session was for the midwives to obtain sufficient training to avoid possible variability in the development of the study and in the collection and registration of data.
* PHASE 3. Pilot study: this was carried out in three randomly selected PCN with 30 pregnant women who were not included in the study in order not to affect the final results. This pilot study evaluated the study inclusion process of the pregnant women, data collection by paper and electronic questionnaire as well as the appointment circuit, referral and presentation of ioduria results.
* PHASE 4. Recruitment of the pregnant women, initial evaluation and request for first ioduria (in IG and NIG):
- Recruitment of the pregnant women: the pregnant women will be consecutively recruited from the women attending consultation to the midwife until the number of 25 women required by each PCN has been reached. Each midwife will know the number of women that they must recruit for the study. If a pregnant woman fulfils the inclusion criteria the midwife will explain the study to her and will ask for her participation. If the woman accepts she will be given the study information sheet in which the objectives and the characteristics are described and she will be asked to sign the informed consent form to thereby be included in the study. If the woman refuses to participate the reasons for this will be noted, as will the administrative, sociodemographic and obstetric variables with the aim of determining the profile of this type of pregnant woman.
- Initial evaluation of the pregnant women: on the first contact with the women and through an individualised interview the midwife will collect the following variables: administrative, sociodemographic, obstetric, those related to smoking, consumption of foods rich in iodine, iodised salt and iodised multiple vitamins. All the data will be reported in an electronic data collection file (EDCF) which will include the rule of internal coherence to guarantee the quality control of the data. Following the interview the midwife will make an educational intervention on the importance of good alimentation during pregnancy and the repercussions this has on maternal and foetal health, with special emphasis on the importance of the consumption of foods rich in iodine and iodised supplements. An informative sheet will also be provided on the importance of iodine during gestation.
- Request for ioduria during the first trimester: the midwife will request an ioduria test and will explain the woman how to correctly collect the urine and will program the appointment for the second trimester visit of the pregnancy. On receipt of the ioduria results the midwife will note these in the EDCF. In cases in which iodine deficiency is detected the midwife will duly intervene, thus the reason for including the telephone number of the pregnant woman in the questionnaire. If iodine supplementation is indicated the administration will begin on collection of the first urine sample to avoid underestimation of the prevalence of iodine deficiency in the first trimester. Ioduria will be analysed using the Benotti&Benotti method performed in the laboratory of the Hospital Clinic of Barcelona.
* PHASE 5. Group Education Intervention (only in IG): the coordinating midwives in each zone will be responsible for performing the educational workshops on hygienic-dietetic habits in the pregnant women in the intervention group. This workshop will be held in the first trimester since this is when organogenesis is produced and is therefore the time of greatest risk for the appearance of alterations in the development of the foetal central nervous system in cases of maternal iodine deficiency. The content of the educational workshop will be the same to avoid a variation in information and transmission of knowledge to the pregnant women, that is, to ensure receipt of homogeneous information by the pregnant women.
* PHASE 6. Follow up (in IG an