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SURVIVAL PLUSS: Increasing Capacity for Mama-baby Survival in Post-conflict Uganda and South Sudan

M

Makerere University

Status

Completed

Conditions

Neonatal Death
Neonatal Hypoglycemia
Low Birthweight
Preterm Birth

Treatments

Behavioral: Intervention arm: An integrated package

Study type

Interventional

Funder types

Other

Identifiers

NCT02605369
2015-121

Details and patient eligibility

About

Universal coverage of good quality facility based care globally could prevent nearly 113,000 maternal deaths, 531,000 stillbirths and 1.3 million neonatal deaths annually by 2020. Yet, only 57% of pregnant Ugandan women choose to deliver at health facilities. This unacceptably low coverage of facility based births could explain, in part, the high maternal and perinatal mortality estimates in Uganda. While multiple studies have examined factors associated with this low utilization of health services around the time of birth, there is inadequate implementation research exploring the best systematic methods that could promote uptake and scale up of facility based births. This study will therefore examine the effect of an intervention package (peer counselling by pregnancy buddies on facility based births, mobile phone messaging promoting facility based births and provision of mama-kits) on the frequency of facility based births and perinatal mortality. The study, a cluster randomized community based intervention trial in post-conflict Northern Uganda, will provide data crucial in framing national policy regarding measures to promote the use of health facilities.

Enrollment

1,877 patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Pregnant women at 28 or more weeks of gestation
  • Residence in the selected clusters
  • Pregnant women under 18 years of age will be included since they are considered as emancipated minors in Uganda

Exclusion criteria

  • Intention to move from the study area within one year
  • Psychiatric ailments that may inhibit the informed consent process

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,877 participants in 2 patient groups

Intervention arm: An integrated package
Experimental group
Description:
Pregnant women in the intervention clusters will receive an integrated package consisting of peer support for facility based births by pregnancy buddies, mama kits and mobile phone messages. These components will all aim at mitigating the three delays and increasing the proportion of facility based births.
Treatment:
Behavioral: Intervention arm: An integrated package
Control arm: Standard of care
No Intervention group
Description:
Pregnant women in the control clusters will continue to receive the standard of care for pregnant women according to Ugandan Ministry of Health guidelines

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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