Client-tailored maternity care to increase maternal empowerment: Cluster randomized controlled trial protocol; The healthy pregnancy 4 All-2 program

Abstract

Background: The postpartum period is an important period for preventive strategies as common maternal and child health risks may become manifest. Women with a lower socioeconomic status tend to have lower maternal empowerment. Increasing their risks of adverse maternal and child health outcomes. This study aims to assess the effectiveness of a primary care level intervention. Delivered to maternity care assistants, aiming to increase maternal empowerment postpartum. Methods: This study is part of the Dutch nationwide "Healthy Pregnancy 4 All-2" (HP4All-2) program, which aims to identify vulnerable mothers and young children at risk of adverse health outcomes, and subsequently improve their care. This program targets women from deprived neighborhoods. A pragmatic cluster randomized controlled trial will be undertaken in 12 maternity care organizations. Maternity care organizations in urban municipalities (i.e. the clusters) will be randomized to either a systematic risk assessment during pregnancy with emphasis on identification of non-medical risk factors for adverse maternal and neonatal health outcomes, and subsequent adaptation of care towards a client-tailored approach during pregnancy and the postpartum period, or solely the systematic risk assessment. The primary outcome is the prevalence of a low maternal empowerment score postpartum. Secondary maternal outcomes cover health-related quality of life, postnatal depression, smoking, alcohol consumption, illicit drug use. Finally, maternal and neonatal health care utilization postpartum are recorded. All outcomes will be analyzed according to the intention-to-treat principle, using multi-level mixed effects models. Discussion: The study will contribute to evidence regarding the effectiveness of client-tailored, risk-based maternity care to increase maternal empowerment postpartum. Trial registration: Netherlands Trial Registry (NTR) 6311, registered 03-27-2017.