Effectiveness of Adaptation of the Dose of Iron Supplementation in Pregnancy on Maternal-child Health. Randomized Clinical Trial (ECLIPSES)

The study will be conducted in 2 Primary Care Centers (PCC) from Tarragona and Reus of the Catalunya Sexual and Reproductive Healthcare Service [Atención a la Salud Sexual y Reproductiva (ASSIR)] of the Catalan Institute of Health [Instituto Catalán de la Salud (ICS)]. The specialist health-care workers include gynecologists and midwives. The participating reproductive health-care services (RHS) provide cover for urban, suburban, and rural PCCs.

The clinical follow-up of the pregnancy in the PCC will be according to the program set by RHS. This includes a clinical visit at recruitment into the present study, a visit every trimester, and one at 40 days post-partum.

In the recruitment visit before week 12 of the pregnancy, the inclusion criteria will be assessed (except the Hb levels and the number of fetuses) as well as the exclusion criteria. Informed consent will be solicited. A clinical history will be recorded, which include date of birth, socioeconomic status, parity, date of last menstruation, corrected date of last menstruation, estimated date of partum, risk factors during pregnancy, pregnancy planning, previous use of contraceptives, clinical antecedents, surgery and personal obstetric data, toxic habits, blood pressure, height, weight of the mother (self-reported at the recruitment visit and measured objectively at each clinical follow-up visit). Similar data from the father will be solicited.

Moreover, a questionnaire regarding the ingestion of iron supplements, multi-vitamins, or other treatments and, if a smoker, the Fagerstrom test for tobacco dependency. A blood sample for standard biochemical analyses (including hemoglobin) will be sent for processing in the centralized laboratory.

At visit 1, around the 12th week of gestation, Hb levels will be evaluated as will be the number of fetuses (using echography) to confirm that the inclusion criteria are fulfilled. If fulfilled, the individuals will be retained in the study and, if not, will be transferred out of the study, and considered a screening failure. The remaining women will be assigned to Stratum 1 or Stratum 2 of the study and will be randomized with respect to iron supplement prescription. Clinical history will be taken, including the use of multi-vitamins and iron supplements and the questionnaires filled-in about food consumption, physical activity, anxiety status and tobacco dependency. ). A physical examination will be performed to measure weight and blood pressure. The ultrasound data on the fetus will be recorded to assess Crown Rump Length (CRL). A physical examination will be performed to measure weight and blood pressure. Venous blood will be taken for analyses, the results of which will be reviewed in the next clinical visit. The iron supplementation that will be needed at the next visit will be prepared for distribution. Adverse events occurring since the previous visit will be recorded.