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

Sponsor
Makerere University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02605369
Collaborator
Centre For International Health (Other)
1,800
1
2
22.9
78.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Intervention arm: An integrated package
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1800 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
SURVIVAL PLUSS: Increasing Capacity for Mama-baby Survival in Post-conflict Uganda and South Sudan
Actual Study Start Date :
Jan 3, 2018
Anticipated Primary Completion Date :
Mar 31, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Facility based birth [Day 1]

    Delivery at a health facility

Secondary Outcome Measures

  1. Neonatal death [Day 28]

    Death within the first month of life

  2. Timely initiation of breastfeeding [Up-to one hour after birth]

    Initiation of breastfeeding with the first hour after birth

  3. Severe illness [Day 28]

    Severe illness within the first month of life

  4. The percent of newborns attended by a health care pro-vider during the first 48 hours following birth [Up-to 48 hours after birth]

    Proportion of babies seen by a health care work in the first 48 hours after birth

  5. The percent of newborns attended by a health care pro-vider during the first 7 days following birth [1 week]

    Proportion of babies seen by a health care work in the first one week after birth

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lira District Lira Uganda

Sponsors and Collaborators

  • Makerere University
  • 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: 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Makerere University
ClinicalTrials.gov Identifier:
NCT02605369
Other Study ID Numbers:
  • 2015-121
First Posted:
Nov 16, 2015
Last Update Posted:
Apr 2, 2019
Last Verified:
Mar 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 2, 2019