Effect of Preconception Care Intervention on Maternal Nutritional Status and Birth Outcome in a Low-Resource Setting: Proposal for a Nonrandomized Controlled Trial

BACKGROUND: The provision of preconception care approaches such as maternal assessments and education on healthy lifestyle (including physical activity, nutrition, and dietary supplements such as folic acid), general and sexual health, avoidance of high-risk behavior, and immunizations has been shown to identify and reduce the risk of adverse birth outcomes through appropriate management and preventive measures. OBJECTIVE: The goal of the study is to determine the effect of an integrated preconception care intervention on delivery outcomes, which is a novel challenge for lowering unfavorable birth outcomes in India’s low-resource setting. The main objectives are to investigate the relationship of birth outcomes to both maternal and paternal preconception health and determine the effect of preconception care intervention on improvement of maternal nutritional status and reduction of the risk of adverse birth outcomes such as prematurity, low birth weight, and maternal and neonatal complications. METHODS: A nonrandomized controlled trial design will be used for comparing 2 groups: preconception care with a standard maternal health care (MHC) program and an integrated MHC program (without preconception care). Two rural field areas of Khordha district, Odisha, will be selected for conducting the study. The study will enroll 782 married women between the ages of 18 and 35 years with their spouses, with 391 women in each group. The couples will receive preconception care based on their health circumstances, and they will be followed up at 3-month intervals before pregnancy. Following pregnancy, they will be followed up for 8 prenatal monitoring and care visits as well as 6 weeks after delivery as part of the standard MCH program. The preconception care intervention package includes couples counseling, contraceptive education and distribution, sex education, lifestyle modification, and nutritional supplementation of iron and folic acid, along with multivitamins if needed. RESULTS: The proposal was approved by the institutional ethical committee for conducting the study in June 2020 (Ref No: T/EMF/Nursing/20/6). Participants were enrolled in phase 1 in April 2021, phase 2 of offering preconception services will begin in August 2021, and study outcomes will be measured from 2023 to 2024. CONCLUSIONS: Through preconception care and counseling, the eligible couples will recognize, embrace, and implement the actions to improve their preconception health. Finally, it is expected that maternal and paternal health will have a significant impact on enhancing maternal nutritional status and birth outcomes. TRIAL REGISTRATION: Clinical Trials Registry–India CTRI/2021/04/032836; http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48239&EncHid=&userName=CTRI/2021/04/032836 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/28148