Swain Dharitri, Begum Jasmina, Parida Swayam Prangnan
College of Nursing, All India Institute of Medical Sciences, Bhubaneswar, India.
Department of Obstetrics & Gynecology, All India Institute of Medical Sciences, Bhubaneswar, India.
JMIR Res Protoc. 2021 Aug 16;10(8):e28148. doi: 10.2196/28148.
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.
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.
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.
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.
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.
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.
孕前保健措施，如孕产妇评估以及关于健康生活方式（包括体育活动、营养和膳食补充剂，如叶酸）、一般健康和性健康、避免高危行为以及免疫接种等方面的教育，已被证明可通过适当的管理和预防措施识别并降低不良出生结局的风险。
本研究的目的是确定综合孕前保健干预对分娩结局的影响，这对于在印度资源匮乏的环境中降低不良出生结局而言是一项新的挑战。主要目标是调查出生结局与孕产妇和父亲孕前健康的关系，并确定孕前保健干预对改善孕产妇营养状况以及降低早产、低出生体重以及孕产妇和新生儿并发症等不良出生结局风险的影响。
将采用非随机对照试验设计来比较两组：接受标准孕产妇保健（MHC）计划的孕前保健组和综合MHC计划组（无孕前保健）。将选择奥里萨邦科德哈区的两个农村地区进行该研究。该研究将招募782名年龄在18至35岁之间的已婚妇女及其配偶，每组391名妇女。这些夫妇将根据自身健康状况接受孕前保健，并在怀孕前每3个月接受一次随访。怀孕后，作为标准妇幼保健计划的一部分，她们将接受8次产前监测和护理访视以及产后6周的随访。孕前保健干预方案包括夫妇咨询、避孕教育与发放、性教育、生活方式改变、铁和叶酸的营养补充，必要时还包括多种维生素。
该提案于2020年6月获得机构伦理委员会批准，以开展此项研究（参考编号：T/EMF/护理/20/6）。参与者于2021年4月进入第一阶段，提供孕前服务的第二阶段将于2021年8月开始，研究结果将在2023年至2024年进行评估。
通过孕前保健和咨询，符合条件的夫妇将认识、接受并采取行动改善其孕前健康。最后，预计孕产妇和父亲的健康状况将对改善孕产妇营养状况和出生结局产生重大影响。
印度临床试验注册中心CTRI/2021/04/032836；http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=4,8239&EncHid=&userName=CTRI/2021/04/032836。
国际注册报告识别码（IRRID）：PRR1-10.2196/28148。
