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

Primary Purpose

Neonatal Death, Preterm Birth, Low Birthweight

Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Intervention arm: An integrated package
Sponsored by
Makerere University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neonatal Death focused on measuring Facility births

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Lira District

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention arm: An integrated package

Control arm: Standard of care

Arm 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.

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

Outcomes

Primary Outcome Measures

Facility based birth
Delivery at a health facility

Secondary Outcome Measures

Neonatal death
Death within the first month of life
Timely initiation of breastfeeding
Initiation of breastfeeding with the first hour after birth
Severe illness
Severe illness within the first month of life
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
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

Full Information

First Posted
November 12, 2015
Last Updated
October 7, 2023
Sponsor
Makerere University
Collaborators
Centre For International Health
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1. Study Identification

Unique Protocol Identification Number
NCT02605369
Brief Title
SURVIVAL PLUSS: Increasing Capacity for Mama-baby Survival in Post-conflict Uganda and South Sudan
Official Title
SURVIVAL PLUSS: Increasing Capacity for Mama-baby Survival in Post-conflict Uganda and South Sudan
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 3, 2018 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
February 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Makerere University
Collaborators
Centre For International Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Death, Preterm Birth, Low Birthweight, Neonatal Hypoglycemia
Keywords
Facility births

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1877 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm: An integrated package
Arm Type
Experimental
Arm 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.
Arm Title
Control arm: Standard of care
Arm Type
No Intervention
Arm 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
Intervention Type
Behavioral
Intervention Name(s)
Intervention arm: An integrated package
Intervention Description
See description in previous column
Primary Outcome Measure Information:
Title
Facility based birth
Description
Delivery at a health facility
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Neonatal death
Description
Death within the first month of life
Time Frame
Day 28
Title
Timely initiation of breastfeeding
Description
Initiation of breastfeeding with the first hour after birth
Time Frame
Up-to one hour after birth
Title
Severe illness
Description
Severe illness within the first month of life
Time Frame
Day 28
Title
The percent of newborns attended by a health care pro-vider during the first 48 hours following birth
Description
Proportion of babies seen by a health care work in the first 48 hours after birth
Time Frame
Up-to 48 hours after birth
Title
The percent of newborns attended by a health care pro-vider during the first 7 days following birth
Description
Proportion of babies seen by a health care work in the first one week after birth
Time Frame
1 week
Other Pre-specified Outcome Measures:
Title
Low birthweight
Description
Proportion of infants with a birthweight =< 2500gms
Time Frame
Up-to 48 hours after birth
Title
Preterm birth
Description
Proportion of infants born at less than 37 completed weeks of gestation measured by the New Ballad Score
Time Frame
7 days postpartum
Title
Neonatal hypoglycemia
Description
Proportion of infants with random blood glucose less than 47mg/dl
Time Frame
Up-to 7 days after birth

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria Nankabirwa, MD, MPH, PhD
Organizational Affiliation
Department of Epidemiology and Biostatistics, School of Public Health, College of Health Sciences, Makerere University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James K Tumwine, MD, PhD
Organizational Affiliation
Makerere University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Grace Ndeezi, MD, PhD
Organizational Affiliation
Makerere Univeristy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thorkild Tylleskar, MD, PhD
Organizational Affiliation
University of Bergen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Wako, MD, PhD
Organizational Affiliation
Busitema University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joyce Kaducu
Organizational Affiliation
Gulu University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jino Meleby
Organizational Affiliation
University of Juba
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frederik Froen, MD, PhD
Organizational Affiliation
Norwegian Institute of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lira District
City
Lira
Country
Uganda

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The datasets used and/or analyzed during the current study will be available on reasonable request
Citations:
PubMed Identifier
33574146
Citation
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.
Results Reference
derived

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

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