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

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.

Study Overview

• Status: Completed
• Conditions: Preterm Birth; Neonatal Death; Low Birthweight; Neonatal Hypoglycemia
• Intervention / Treatment: Behavioral: Intervention arm: An integrated package

• Study Type: Interventional
• Enrollment (Actual): 1877
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Lira, Uganda
    • Lira District

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm: An integrated package; 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; See description in previous column
No Intervention: Control arm: Standard of care; Pregnant women in the control clusters will continue to receive the standard of care for pregnant women according to Ugandan Ministry of Health guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Facility based birth	Delivery at a health facility	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal death	Death within the first month of life	Day 28
Timely initiation of breastfeeding	Initiation of breastfeeding with the first hour after birth	Up-to one hour after birth
Severe illness	Severe illness within the first month of life	Day 28
The percent of newborns attended by a health care pro-vider during the first 48 hours following birth	Proportion of babies seen by a health care work in the first 48 hours after 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	Proportion of babies seen by a health care work in the first one week after birth	1 week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low birthweight	Proportion of infants with a birthweight =< 2500gms	Up-to 48 hours after birth
Preterm birth	Proportion of infants born at less than 37 completed weeks of gestation measured by the New Ballad Score	7 days postpartum
Neonatal hypoglycemia	Proportion of infants with random blood glucose less than 47mg/dl	Up-to 7 days after birth

Collaborators and Investigators

• Sponsor: Makerere University
• Collaborators: Centre For International Health
• Investigators: Principal Investigator: Victoria Nankabirwa, MD, MPH, PhD, Department of Epidemiology and Biostatistics, School of Public Health, College of Health Sciences, Makerere University; Principal Investigator: Frederik Froen, MD, PhD, Norwegian Institute of Public Health; 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2018
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: November 12, 2015
• First Submitted That Met QC Criteria: November 12, 2015
• First Posted (Estimated): November 16, 2015

Study Record Updates

• Last Update Posted (Actual): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 7, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Facility births
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Body Weight; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Death; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypoglycemia; Premature Birth; Birth Weight; Perinatal Death
• Other Study ID Numbers: 2015-121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The datasets used and/or analyzed during the current study will be available on reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No