Clinical trial NCT02605369: 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
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Death
Preterm Birth
Low Birthweight
Neonatal Hypoglycemia
Keywords: Facility births
Lead sponsor: Makerere University
Sponsor class: OTHER
Collaborators: name: Centre For International Health
First posted: 2015-11-16
Enrollment: 1877
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Facility based birth
timeFrame: Day 1
Secondary outcomes:
measure: Neonatal death
timeFrame: Day 28
measure: Timely initiation of breastfeeding
timeFrame: Up-to one hour after birth
measure: Severe illness
timeFrame: Day 28
measure: The percent of newborns attended by a health care pro-vider during the first 48 hours following birth
timeFrame: Up-to 48 hours after birth
measure: The percent of newborns attended by a health care pro-vider during the first 7 days following birth
timeFrame: 1 week
Other outcomes:
measure: Low birthweight
timeFrame: Up-to 48 hours after birth
measure: Preterm birth
timeFrame: 7 days postpartum
measure: Neonatal hypoglycemia
timeFrame: Up-to 7 days after birth
Locations:
city: Lira
country: Uganda
facility: Lira District
Study officials:
affiliation: Department of Epidemiology and Biostatistics, School of Public Health, College of Health Sciences, Makerere University
name: Victoria Nankabirwa, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Makerere University
name: James K Tumwine, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Makerere Univeristy
name: Grace Ndeezi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bergen
name: Thorkild Tylleskar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Busitema University
name: Paul Wako, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gulu University
name: Joyce Kaducu
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Juba
name: Jino Meleby
role: PRINCIPAL_INVESTIGATOR
affiliation: Norwegian Institute of Public Health
name: Frederik Froen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.