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. 2023 Nov 29;19(4):e1361. doi: 10.1002/cl2.1361
Methods Individual Randomized Controlled Trial in Hospitals of Latin America (Rosario, Argentina, Pelotas, Brazil, Havana, Cuba, Mexico City, Mexico)
Participants

Inclusion criteria: Women initiating prenatal care between the fifteenth and twenty‐second weeks of gestation with singleton pregnancies; without clinical evidence of cardiovascular, renal, or other chronic diseases; history of cerclage. Rh‐negative, or mental diseases, but with at least one of the following risk factors were eligible for the study: (1) previous low‐birth‐weight or infant death; (2) previous fetal, neonatal or infant death (3) <17 years old; (4) body weight < 50 kg and height < 1.5; (5) low family income defined by locally adapted cutoff points; (6) <3 years of schooling; (7) smoking or heavy alcohol consumption; and (8) single, separated, divorced or widowed.

Exclusion criteria: Not reported

Age [Mean (SD)]—Intervention, Control:

24.3 (6.6), 24.6 (6.6)

White Race [n (%)]—Intervention, Control:

669 (60.3), 609 (59.8)

Employed [n (%)]—Intervention, Control:

330 (29.7), 309 (30.3)

Education (years) [Mean (SD)]—Intervention, Control:

8.4 (3.7), 8.4 (3.8)

Low income [n (%)]—Intervention, Control:

(55.1), (54.9)

Married [n (%)]—Intervention, Control:

509 (45.9), 486 (47.7)

Interventions

Intervention—Nutrition counseling (n = 1110)

Description: The first part of the visit was devoted to encouraging the pregnant woman and her support person to discuss the pregnancy situation, changes, worries, and doubts. By using this information as background, the home visitor adapted the predefined themes, focusing the program on information that could be relevant to each woman. The home visitor discussed the developed strategy with the study supervisor after the first visit, and the final plan of the intervention for that woman, was developed. Changes were made, if needed, during subsequent visits. Activities during each visit and follow‐up recommendations were focused on strengthening the pregnant woman's social network, including from the first visit a support person selected by the patient to share with her all‐intervention activities. The support person could be the husband or partner, mother, sister, friend, or neighbor. The support person was encouraged to be involved throughout the pregnancy, to participate in the decision‐making process, helping the mother to resolve personal problems and promote healthy behavior and prenatal care attendance. The home visitor provided direct emotional support to the woman and helped her resolve problems related to the implementation of medical recommendations or prenatal care attendance. A special patient support office that did not require a previous appointment, with a hot line, was located at the hospitals only for patients in the intervention group. It was intended to help women with problems related to care attendance, the implementation of any indicated treatment or laboratory tests, and the monitoring of doctors’ recommendations.

Nutrition counseling messaging: health education provided during home visit; this included education about nutrition, relevance and schedule of prenatal care, recognition of alarm signs, opportunity of hospital attendance, and suggestions about reducing smoking and alcohol or drug use. Educational activities conducted during the home visit were reinforced with a poster simulating a path for a healthy pregnancy and a booklet provided during the first home visit. These materials gave indications and encouragement, using familiar terms and situations, of different health and nutritional activities recommended during pregnancy.

Intervention adapted to local context: The manual included detailed descriptions of various situations that home visitors were likely to encounter, with suggested interventions. It was intended that home visitors at the different study sites would act in a similar way, with adaptations appropriate to the local culture.

Women empowerment approach: Partial empowerment model (i.e., including agency‐related activities only.

Control (n = 1019)

Description: The control group was provided with the routine prenatal care available at each of the participating institutions.

Outcomes Anemia, hemorrhage, adherence to nutrition counseling, stillbirths, Low birthweight
Notes Funding: Supported by a grant from the International Development Research Center, Ottawa, Canada.