Strengthening Facility-based Intrapartum/Immediate Newborn Care to Reduce Mortality of Preterm Infants in Migori County, Kenya and Busoga Region, Uganda

NCT03112018 | Completed

• 1 other identifier: A123218-K/U
• Study Type: interventional
• Target: 102,988
• Locations: 2 countries
• Sites: 2

Brief Summary

The purpose of this study is to determine whether a combination of evidence-based strategies can improve intrapartum and newborn care in facilities to reduce mortality among preterm infants. This will be a cluster randomized implementation science study across 23 facilities in Eastern Uganda and Western Kenya. Selected interventions will be supported in facilities to measure impact during the study period. These interventions are: a) data strengthening and data use activities; b) implementation of a modified WHO Safe Childbirth Checklist with an emphasis on preterm labor and preterm babies; c) simulation-based provider training and mentoring on key existing evidence-based practices to improve newborn outcomes; d) support of Quality Improvement (QI) cycles to identify and resolve facility-specific issues and bottlenecks. A two-stage design will be used where all study facilities will receive some aspects of the intervention initially, namely data strengthening and the modified checklist. Subsequently, the remaining interventions (QI cycles and simulation training of providers) will be rolled out to a randomly selected half of the facilities in the first stage. At a second stage, the remaining half of the facilities will receive the remaining interventions.

Conditions

Pregnancy Complications; Preterm Labor; PreTerm Birth; Stillbirth; Low Birth Weight

Keywords

premature birth; neonatal mortality; premature infant

Outcome Measures

Primary Outcomes (1)

• all-cause neonatal mortality among preterms/low birth weight newborns

  To determine the effect of the full package (data strengthening, mSCC, provider training and mentoring using the PRONTO method, QI cycles) on 28-day all-cause mortality rate among low birth weight neonates greater than 1000 grams and less than 2500 grams, and neonates between 2500 and 2999 grams with documented gestational age less than 37 weeks

  28-days after facility-based delivery

Secondary Outcomes (6)

• Data quality of key indicators in facility-based registers

  through study completion, an average of 18 months

• Pre-hospital discharge mortality among preterm infants and babies born alive between 500 and 999 grams at birth

  at hospital discharge, an average of 1-7 days

• 28-day mortality among babies born alive between 500 and 999 grams at birth

  28-days after facility-based delivery

• Average number of evidence-based practices demonstrated in simulated case videos and live birth observations

  Baseline and through study completion, an average of 18 months

• Prevalence of preterm birth phenotypes in the study sites as measured by chart review and the mSCC

  Every year over four years

Study Arms (2)

Standard care

ACTIVE COMPARATOR

* Data strengthening * modified Safe Childbirth Checklist (mSCC) implementation

Behavioral: data strengthening; Behavioral: modified Safe childbirth checklist - control

Enhanced care (intervention)

EXPERIMENTAL

* Data strengthening * modified Safe Childbirth Checklist (mSCC) implementation * Health provider training (PRONTO) * Quality Improvement (QI) Cycles

Behavioral: data strengthening; Behavioral: modified Safe childbirth checklist - enhanced; Behavioral: PRONTO training; Behavioral: QI cycles

Interventions

data strengthening BEHAVIORAL

Data strengthening: initial training, monthly data collection and feedback on data quality, access to dashboards, periodic Data Quality Assessments

Enhanced care (intervention); Standard care

modified Safe childbirth checklist - control BEHAVIORAL

modified Safe Childbirth Checklist (mSCC) implementation: provision of the mSCC to facilities, limited feedback and mentoring on its use

Standard care

modified Safe childbirth checklist - enhanced BEHAVIORAL

modified Safe Childbirth Checklist (mSCC) implementation: provision of the mSCC to facilities, ongoing intensive feedback and mentoring on its use

Enhanced care (intervention)

PRONTO training BEHAVIORAL

Health provider training (PRONTO): initial 2-days modular training followed by a 6-week mentoring sessions (Kenya) or periodic modular refreshers and supplemental mentoring (Uganda), each over a 9-12 month period

Enhanced care (intervention)

QI cycles BEHAVIORAL

Quality Improvement Cycles (QI): facility teams performing PDSA cycles with mentoring support and twice annual Learning Collaborative sessions, plus opportunities to apply for small amounts of funds to support change efforts

Enhanced care (intervention)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals: Investigators will include in the analysis the birth outcomes of all women accessing delivery care services at selected hospitals with gestational age of \> 24 weeks who are either admitted for labor or for hospitalization for another antenatal complication (preeclampsia, chorioamnionitis) or referred to a tertiary hospital. Women will be presenting at either control or intervention sites and their delivery information will be reviewed. For follow-up, the investigators will select women with infants born at greater than 1000 grams and less than 2500 grams, or between 2501 and 2999 grams with documented gestational age less than 37 weeks.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Makerere University: collaborator
• Kenya Medical Research Institute: collaborator

Study Sites (2)

Health facilities in Migori County: Rongo, Kehancha, Uriri, Kegonga, Karungu, Tisinye, Isibania, Macalder, Awendo, Ntimaru, Muhuru, Bugumbe, Nyamaraga, Othoro, St. Joseph, St. Camillus, Migori County Referral Hospital

Migori County, Migori County, Kenya

Location

Health facilities in Busoga Region: Bugiri, Buluba, Iganga, Kamuli Government, Kamuli Mission, Jinja Regional Referral Hospital

Busoga Region, Uganda

Location

Related Publications (9)

• Mandu R, Miller L, Namazzi G, Twum-Danso N, Achola KJA, Cooney I, Butrick E, Santos N, Masavah L, Nyakech A, Kirumbi L, Waiswa P, Walker D. Quality improvement collaboratives as part of a quality improvement intervention package for preterm births at sub-national level in East Africa: a multi-method analysis. BMJ Open Qual. 2023 Dec 21;12(4):e002443. doi: 10.1136/bmjoq-2023-002443.

  PMID: 38135302 DERIVED

• Martin-Herz SP, Otieno P, Laanoi GM, Moshi V, Olieng'o Okoth G, Santos N, Walker D. Growth and neurodevelopmental outcomes of preterm and low birth weight infants in rural Kenya: a cross-sectional study. BMJ Open. 2023 Aug 31;13(8):e064678. doi: 10.1136/bmjopen-2022-064678.

  PMID: 37652593 DERIVED

• Ghosh R, Otieno P, Butrick E, Santos N, Waiswa P, Walker D; Preterm Birth Initiative Kenya and Uganda Implementation Research Collaborative. Effect of a quality improvement intervention for management of preterm births on outcomes of all births in Kenya and Uganda: A secondary analysis from a facility-based cluster randomized trial. J Glob Health. 2022 Dec 29;12:04073. doi: 10.7189/jogh.12.04073.

  PMID: 36580073 DERIVED

• Ghosh R, Santos N, Butrick E, Wanyoro A, Waiswa P, Kim E, Walker D. Stillbirth, neonatal and maternal mortality among caesarean births in Kenya and Uganda: a register-based prospective cohort study. BMJ Open. 2022 Apr 6;12(4):e055904. doi: 10.1136/bmjopen-2021-055904.

  PMID: 35387820 DERIVED

• Whaley B, Butrick E, Sales JM, Wanyoro A, Waiswa P, Walker D, Cranmer JN. Using clinical cascades to measure health facilities' obstetric emergency readiness: testing the cascade model using cross-sectional facility data in East Africa. BMJ Open. 2022 Apr 4;12(4):e057954. doi: 10.1136/bmjopen-2021-057954.

  PMID: 35379635 DERIVED

• Achola KA, Kajjo D, Santos N, Butrick E, Otare C, Mubiri P, Namazzi G, Merai R, Otieno P, Waiswa P, Walker D. Implementing the WHO Safe Childbirth Checklist modified for preterm birth: lessons learned and experiences from Kenya and Uganda. BMC Health Serv Res. 2022 Mar 3;22(1):294. doi: 10.1186/s12913-022-07650-x.

  PMID: 35241076 DERIVED

• Namazzi G, Achola KA, Jenny A, Santos N, Butrick E, Otieno P, Waiswa P, Walker D; Preterm Birth Initiative Kenya & Uganda Implementation Research Collaborative. Implementing an intrapartum package of interventions to improve quality of care to reduce the burden of preterm birth in Kenya and Uganda. Implement Sci Commun. 2021 Jan 28;2(1):10. doi: 10.1186/s43058-021-00109-w.

  PMID: 33509293 DERIVED

• Walker D, Otieno P, Butrick E, Namazzi G, Achola K, Merai R, Otare C, Mubiri P, Ghosh R, Santos N, Miller L, Sloan NL, Waiswa P; Preterm Birth Initiative Kenya and Uganda Implementation Research Collaborative. Effect of a quality improvement package for intrapartum and immediate newborn care on fresh stillbirth and neonatal mortality among preterm and low-birthweight babies in Kenya and Uganda: a cluster-randomised facility-based trial. Lancet Glob Health. 2020 Aug;8(8):e1061-e1070. doi: 10.1016/S2214-109X(20)30232-1.

  PMID: 32710862 DERIVED

• Otieno P, Waiswa P, Butrick E, Namazzi G, Achola K, Santos N, Keating R, Lester F, Walker D. Strengthening intrapartum and immediate newborn care to reduce morbidity and mortality of preterm infants born in health facilities in Migori County, Kenya and Busoga Region, Uganda: a study protocol for a randomized controlled trial. Trials. 2018 Jun 5;19(1):313. doi: 10.1186/s13063-018-2696-2.

  PMID: 29871696 DERIVED

Related Links

• PRONTO website

MeSH Terms

Conditions

Pregnancy Complications; Obstetric Labor, Premature; Premature Birth; Stillbirth

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor Complications; Fetal Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dilys Walker, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Peter Waiswa, MD, MPH, PhD

  Makerere University School of Public

  PRINCIPAL INVESTIGATOR

• Phelgona Otieno, MBChB, MPH

  Kenya Medical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Preterm Birth Initiative East Africa; University of California, San Francisco

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: April 13, 2017
• Study Start: October 1, 2016
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: June 18, 2019

Record last verified: 2019-06

Locations

KE (1); UG (1)