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OpenTrials
Completed

NCT Number: NCT02605369

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention arm: An integrated package

Behavioral

See description in previous column

Primary outcomes

  1. Facility based birth

    Time frame: Day 1

    Delivery at a health facility

Secondary outcomes

  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

Other outcomes

  1. Low birthweight

    Time frame: Up-to 48 hours after birth

    Proportion of infants with a birthweight =< 2500gms

  2. Preterm birth

    Time frame: 7 days postpartum

    Proportion of infants born at less than 37 completed weeks of gestation measured by the New Ballad Score

  3. Neonatal hypoglycemia

    Time frame: Up-to 7 days after birth

    Proportion of infants with random blood glucose less than 47mg/dl

Sponsors and collaborators

Lead sponsor

Makerere University

Other

Collaborators

  • Centre For International Health

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 16, 2015
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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