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Providing an optimal start for vulnerable mother and child dyads during the early postpartum period.

Providing an optimal start for vulnerable mother and child dyads during the early postpartum period: a randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22820
Enrollment
494
Registered
2019-09-10
Start date
2019-10-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy, patient tailored care, maternity care, antenatal care, maternal empowerment, eHealth

Interventions

eHealth application with reliable information, supporting text messages and questionnaires. Structured risk screening at 25 weeks of gestations by MCOs. Risk-guided tailored care during pregnancy an

Sponsors

ZonMw (the Netherlands Organisation for Health Research and Development). The funders have no role in study design, data collection and analysis, decision to publish, or preparation of manuscripts
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: A pregnant woman is eligible if she is vulnerable (patient is assessed on her vulnerability during subscription to one of the participating MCOs). Vulnerability is defined as 3 or more problems during pregnancy.

Exclusion criteria

Exclusion criteria: • gestational age above 25 weeks; • under-aged women: under the age of 16 years; • having a smart phone that is not compatible with the eHealth application: without Android or iOS operating system; • insufficient command of the Dutch language: that text can be read and understood; • unwillingness to sign a digital informed consent form in the eHealth application.

Design outcomes

Primary

MeasureTime frame
Primary outcome The primary outcome is the prevalence of low maternal empowerment postpartum and will be assessed via the Maternity Empowerment Questionnaire (MEQ) during pregnancy and postpartum. The MEQ consists of five domains: (1) Looking after yourself, (2) My baby, (3) My family, (4) The future, and (5) Maternity care. The fifth domain “Maternity care” will not be considered for the maternal empowerment, since it directly assesses the extent to which maternity care has contributed to the participants’ empowerment. The first three domains are part of the structured risk assessment during pregnancy. The full MEQ is assed at the fifth day postpartum and six weeks postpartum. Maternal empowerment is defined as the median score across the first four domains within the MEQ. Low maternal empowerment is defined as a score beneath the 20th centile of all empowerment scores within the control arm. the MEQ is assessed at the first week postpartum and 6 weeks postpartum.

Secondary

MeasureTime frame
• Maternal health related quality of life (PROMIS-10) • Maternal (postpartum) depression (EPDS) • Maternal confidence in breastfeeding (BSES-SF) along with success rates • Maternal satisfaction with the provided care (two short questionnaires “shared decision making” and “confidence in care providers”, developed by ICHOM in the Pregnancy & Childbirth Standard Set) [ref] • Lifestyle factors such as maternal smoking, alcohol consumption, and drug use • Feasibility of the eHealth application (usage of the application, user experience among participants and MCOs)

Contacts

Public ContactLyzette Laureij

Erasmus MC

l.laureij@erasmusmc.nl010 - 7037006

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)