|- candidate number||26958|
|- NTR Number||NTR6311|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-mrt-2017|
|- Secondary IDs||2015-156 MEC|
|- Public Title||Healthy Pregnancy 4 All -2: Maternity care|
|- Scientific Title||Systematic risk assessment and customized maternity care to increase maternal empowerment postpartum: the Healthy Pregnancy 4 All-2 study.
|- ACRONYM||Healthy Pregnancy 4 All-2 (HP4All) study.|
|- hypothesis||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. |
|- Healt Condition(s) or Problem(s) studied||Pregnancy|
|- Inclusion criteria||Support for the study in a maternity care organisation was sought from senior staff, and executives with responsibility for clinical quality and safety. Maternity care organisations were required to demonstrate sufficient capacity to maximise their engagement with the study. The studied intervention requires an interview scheduled at home for each client. All pregnant women cared for by participating maternity care organisations, which have a scheduled home visit during pregnancy, within the selected postal codes of the participating municipalities, are invited to take part in the trial. |
|- Exclusion criteria||Exclusion criteria are not having a planned home visit during pregnancy and inadequate knowledge of the Dutch language, English language, Polish language, or Turkish language. |
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-aug-2015|
|- planned closingdate||1-aug-2017|
|- Target number of participants||1711|
|- Interventions||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.
|- Primary outcome||The primary outcome is the mean overall maternal empowerment score (range 1-4), assessed using the Maternal Empowerment Questionnaire (MEQ) between day 7 and 14 postpartum. |
|- Secondary outcome||Secondary outcomes are: maternal physical health assessed by The Short Form Health Survey (SF-36) between day seven and 14 postpartum, the Edinburgh Postnatal Depression Scale (EPDS) assessed six to 12 weeks postpartum, the initiation of breastfeeding (no/yes), the prolongation of breastfeeding (categorical: continued, added formula feeding, stopped) measured at two separate time point; first between day seven to 14 postpartum, and second between six to twelve weeks postpartum, parental compliance with neonatal vitamin-K supplementation when breastfeeding (no/yes), parental compliance with neonatal safe sleep practices (no/yes), maternal smoking behaviour postpartum (no/yes), maternal alcohol use postpartum (no/yes), and additional maternal and neonatal health care utilization in the first three months postpartum (no/yes) assessed between six to 12 weeks postpartum.
In addition, we will assess implementation of our study protocol via questionnaires addressed to managers of maternity care organisations and to local researchers.|
|- Timepoints||Risk-assessment during pregnancy (between 28-37 weeks of pregnancy). Follow questionnaires postpartum; firstly 7-14 days postpartum, and secondly 6-12 weeks postpartum. |
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Ph.D. student, MD J Lagendijk|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. E.A.P. Steegers|
|- Sponsor/Initiator ||Ministry of Health, Welfare and Sports|
(Source(s) of Monetary or Material Support)
|Ministry of Health, Welfare and Sports|
|- Brief summary||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.
|- Main changes (audit trail)|
|- RECORD||27-mrt-2017 - 31-mei-2017|