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

NCT02605369 | Completed DMC

• 1 other identifier: 2015-121
• Study Type: interventional
• Target: 1,877
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neonatal Death; Preterm Birth; Low Birthweight; Neonatal Hypoglycemia

Keywords

Facility births

Outcome Measures

Primary Outcomes (1)

• Facility based birth

  Delivery at a health facility

  Day 1

Secondary Outcomes (5)

• Neonatal death

  Day 28

• Timely initiation of breastfeeding

  Up-to one hour after birth

• Severe illness

  Day 28

• The percent of newborns attended by a health care pro-vider during the first 48 hours following birth

  Up-to 48 hours after birth

• The percent of newborns attended by a health care pro-vider during the first 7 days following birth

  1 week

Other Outcomes (3)

• Low birthweight

  Up-to 48 hours after birth

• Preterm birth

  7 days postpartum

• Neonatal hypoglycemia

  Up-to 7 days after birth

Study Arms (2)

Intervention arm: An integrated package

EXPERIMENTAL

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.

Behavioral: Intervention arm: An integrated package

Control arm: Standard of care

NO INTERVENTION

Pregnant women in the control clusters will continue to receive the standard of care for pregnant women according to Ugandan Ministry of Health guidelines

Interventions

Intervention arm: An integrated package BEHAVIORAL

See description in previous column

Intervention arm: An integrated package

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Makerere University: lead
• Centre For International Health: collaborator

Study Sites (1)

Lira District

Lira, Uganda

Location

Related Publications (2)

• Nankabirwa V, Mukunya D, Ndeezi G, Odongkara B, Arach AA, Achora V, Mugenyi L, Sebit MB, Wandabwa JN, Waako P, Tylleskar T, Tumwine JK. Can an integrated intervention package including peer support increase the proportion of health facility births? A cluster randomised controlled trial in Northern Uganda. BMJ Open. 2024 Feb 7;14(2):e070798. doi: 10.1136/bmjopen-2022-070798.

  PMID: 38326267 DERIVED

• Mukunya D, Tumwine JK, Nankabirwa V, Odongkara B, Tongun JB, Arach AA, Tumuhamye J, Napyo A, Zalwango V, Achora V, Musaba MW, Ndeezi G, Tylleskar T. Neonatal hypothermia in Northern Uganda: a community-based cross-sectional study. BMJ Open. 2021 Feb 11;11(2):e041723. doi: 10.1136/bmjopen-2020-041723.

  PMID: 33574146 DERIVED

MeSH Terms

Conditions

Perinatal Death; Premature Birth

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications

Study Officials

• Victoria Nankabirwa, MD, MPH, PhD

  Department of Epidemiology and Biostatistics, School of Public Health, College of Health Sciences, Makerere University

  PRINCIPAL INVESTIGATOR

• James K Tumwine, MD, PhD

  Makerere University

  PRINCIPAL INVESTIGATOR

• Grace Ndeezi, MD, PhD

  Makerere Univeristy

  PRINCIPAL INVESTIGATOR

• Thorkild Tylleskar, MD, PhD

  University of Bergen

  PRINCIPAL INVESTIGATOR

• Paul Wako, MD, PhD

  Busitema University

  PRINCIPAL INVESTIGATOR

• Joyce Kaducu

  Gulu University

  PRINCIPAL INVESTIGATOR

• Jino Meleby

  University of Juba

  PRINCIPAL INVESTIGATOR

• Frederik Froen, MD, PhD

  Norwegian Institute of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2015
• First Posted: November 16, 2015
• Study Start: January 3, 2018
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

UG (1)