Healthy Pregnancy 4 All -2: Maternity care

This study uses a cluster randomized controlled trial design in six municipalities in the Netherlands, including 12 maternity care organisations at 15 different locations throughout the country. In each municipality, both an intervention, and a control cluster are formed. The intervention under study is a systematic risk assessment for medical and non-medical risk factors during pregnancy in conjunction with client-tailored care during pregnancy and the postpartum period. The primary outcome is maternal empowerment measured between day six and 14 postpartum. The results from this trial will provide evidence on whether structured risk assessments in conjunction with patient-tailored care for high-risk pregnant women by maternity care providers is feasible in terms of effectiveness and implementation.

The results from this trial will provide evidence on whether structured risk assessments and customized maternity care for high-risk pregnant women by maternity care providers is feasible in terms of effectiveness, especially regarding maternal empowerment.

Risk-assessment during pregnancy (between 28-37 weeks of pregnancy). Follow questionnaires postpartum; firstly 7-14 days postpartum, and secondly 6-12 weeks postpartum.

The study is embedded in the Healthy Pregnancy 4 All- 2 program (HP4All-2), a nationwide program in the Netherlands that aims to reduce health inequalities and improve the care for young children and their mothers.

Within the intervention clusters, participants will receive a structured risk assessment during pregnancy. The risk assessment focuses on medical and non-medical risk factors. The consequent content of the intervention is informed by these outcomes with proactive, client-tailored care during pregnancy, labour, and the postpartum period. The risk assessment is based on the Mind2Care (M2C); a Dutch screen-and-advice tool developed and validated for routine us in antenatal obstetric care, complemented with an adjusted form of the Maternal Empowerment Questionnaire (MEQ).

The personalised care pathways are based on standard care pathways within each participating organisation and within the participating municipality. Participants in the control clusters will receive the same risk assessment. This assessment will however be followed by conventional maternity care during pregnancy, labour, and the postpartum period.

The local researcher, a trained maternity care professional or assistant, will be the contact between the study-team and the participants. All local researchers involved in interviewing participants will be educated extensively to use the risk assessment and to guide the participants in answering the questions within the risk assessment. This education exists of two sessions of three hours and will be guided by a well-established Dutch educational agency together with the principal investigator of the research team. In-service training consists of the risk factors that will be evaluated using the risk assessment tool, the association between risk factors and adverse health outcomes, the possible tailored care towards women’s circumstances and needs, and strengthening women’s capabilities. It further contains group exercises in communication and respect, in order to correctly include participants in a research project and to answer questions of participants in an proper way.