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

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ClinicalTrials.gov Identifier: NCT02605369
Recruitment Status : Recruiting
First Posted : November 16, 2015
Last Update Posted : April 2, 2019
Sponsor:
Collaborator:
Centre For International Health
Information provided by (Responsible Party):
Makerere University

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
Neonatal Death Behavioral: Intervention arm: An integrated package Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 3, 2018
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : December 2019

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



Primary Outcome Measures :
  1. Facility based birth [ Time Frame: Day 1 ]
    Delivery at a health facility


Secondary Outcome Measures :
  1. Neonatal death [ Time Frame: Day 28 ]
    Death within the first month of life

  2. Timely initiation of breastfeeding [ Time Frame: Up-to one hour after birth ]
    Initiation of breastfeeding with the first hour after birth

  3. Severe illness [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 week ]
    Proportion of babies seen by a health care work in the first one week after birth



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02605369


Contacts
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Contact: Victoria Nankabirwa, MD, MPH, PhD +256755757460 nankabirwav@gmail.com
Contact: James K Tumwine, MD, PhD +256772494120 kabaleimc@gmail.com

Locations
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Uganda
Lira District Recruiting
Lira, Uganda
Contact: Victoria Nankabirwa, MBChB    +256755757460      
Principal Investigator: Victoria Nankabirwa, MBChB         
Sponsors and Collaborators
Makerere University
Centre For International Health
Investigators
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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

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Responsible Party: Makerere University
ClinicalTrials.gov Identifier: NCT02605369     History of Changes
Other Study ID Numbers: 2015-121
First Posted: November 16, 2015    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Perinatal Death
Pregnancy Complications
Death
Pathologic Processes