PACTR202402576062416Not yet recruitingUnknown
Evaluation of a multicomponent intervention to improve perinatal bereavement support for women and families after stillbirth and neonatal death in Kenya and Uganda: A pragmatic cluster randomised controlled trial.
iverpool School of Tropical Medicine0 sites840 target enrollmentStarted: November 8, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 840
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 13 Year(s) to 18 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Women, birthed or received in-patient postnatal care in the included facility:
- •- Outcome of the index pregnancy was a stillbirth (e.g., WHO antenatal or intrapartum fetal death = 28 weeks’ gestation or national definition) or neonatal death (live birth at any gestation, baby(ies) died up to 28 days following birth in the facility.
- •- Over 16 years* at time of recruitment (whilst 18 years is age of majority, women over 16 years old who are pregnant, married, have a child or cater for their own livelihood are considered emancipated minors for the purposes of research(22), 16-18 year olds have high rates of adverse pregnancy outcomes including stillbirth and neonatal death and may benefit from the intervention and research.
- •- Able to speak Luganda, English or Kiswahili.
Exclusion Criteria
- •Women who had a multiple birth, where one baby was liveborn and is still living.
Investigators
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