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

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02605369
• Other study ID #: 2015-121
• Status: Completed
• Phase: N/A
• Start date: January 3, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: October 2023
• Source: Makerere University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1877
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Hypoglycemia
• Low Birthweight
• Neonatal Death
• Neonatal Hypoglycemia
• Perinatal Death
• Premature Birth
• Preterm Birth

Intervention

Behavioral:
• Intervention arm: An integrated package
See description in previous column

Locations

Country	Name	City	State
Uganda	Lira District	Lira

Sponsors (2)

Lead Sponsor	Collaborator
Makerere University	Centre For International Health

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Low birthweight	Proportion of infants with a birthweight =< 2500gms	Up-to 48 hours after birth
Other	Preterm birth	Proportion of infants born at less than 37 completed weeks of gestation measured by the New Ballad Score	7 days postpartum
Other	Neonatal hypoglycemia	Proportion of infants with random blood glucose less than 47mg/dl	Up-to 7 days after birth
Primary	Facility based birth	Delivery at a health facility	Day 1
Secondary	Neonatal death	Death within the first month of life	Day 28
Secondary	Timely initiation of breastfeeding	Initiation of breastfeeding with the first hour after birth	Up-to one hour after birth
Secondary	Severe illness	Severe illness within the first month of life	Day 28
Secondary	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
Secondary	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