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

NCT ID: NCT02605369

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1877 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-03
• Study Completion Date: 2019-02-28

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.

Conditions

Neonatal Death; Preterm Birth; Low Birthweight; Neonatal Hypoglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Intervention arm: An integrated package

Intervention Type: BEHAVIORAL

See description in previous column

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intervention arm: An integrated package

See description in previous column

Intervention Type: BEHAVIORAL

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Centre For International Health

OTHER

Sponsor Role: collaborator

Makerere University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Victoria Nankabirwa, MD, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Epidemiology and Biostatistics, School of Public Health, College of Health Sciences, Makerere University

James K Tumwine, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Makerere University

Grace Ndeezi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Makerere Univeristy

Thorkild Tylleskar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bergen

Paul Wako, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Busitema University

Joyce Kaducu

Role: PRINCIPAL_INVESTIGATOR

Gulu University

Jino Meleby

Role: PRINCIPAL_INVESTIGATOR

University of Juba

Frederik Froen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian Institute of Public Health

Locations

Lira District

Lira, , Uganda

Countries

Uganda

References

Nankabirwa V, Mukunya D, Ndeezi G, Odongkara B, Arach AA, Achora V, Mugenyi L, Sebit MB, Wandabwa JN, Waako P, Tylleskar T, Tumwine JK. Can an integrated intervention package including peer support increase the proportion of health facility births? A cluster randomised controlled trial in Northern Uganda. BMJ Open. 2024 Feb 7;14(2):e070798. doi: 10.1136/bmjopen-2022-070798.

Reference Type: DERIVED

PMID: 38326267 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33574146 (View on PubMed)

Other Identifiers

2015-121

Identifier Type: -

Identifier Source: org_study_id