NCT03112018: PTBi-KE-UG

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

Completed NA Last updated 18 June 2019

What this trial tests

NA trial testing data strengthening in Pregnancy Complications in 102,988 participants. Completed in 31 May 2019.

Timeline

1 October 2016

Primary endpoint
31 May 2019

31 May 2019

Quick facts

Lead sponsor	University of California, San Francisco
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	102,988
Start date	1 October 2016
Primary completion	31 May 2019
Estimated completion	31 May 2019
Sites	2 locations across Kenya, Uganda

Drugs / interventions tested

• data strengthening
• modified Safe childbirth checklist - control
• modified Safe childbirth checklist - enhanced
• PRONTO training
• QI cycles

Conditions studied

• Pregnancy Complications — all drugs for Pregnancy Complications →
• Preterm Labor — all drugs for Preterm Labor →
• PreTerm Birth — all drugs for PreTerm Birth →
• Stillbirth — all drugs for Stillbirth →

Sponsor

University of California, San Francisco

Who can join

Eligibility, any sex, with Pregnancy Complications or Preterm Labor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Walker D, Otieno P, Butrick E, Namazzi G, et al · · 2020 · cited 60× · PMID 32710862 · DOI 10.1016/s2214-109x(20)30232-1
2. 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.
   Otieno P, Waiswa P, Butrick E, Namazzi G, et al · · 2018 · cited 23× · PMID 29871696 · DOI 10.1186/s13063-018-2696-2
3. Defining and estimating effects in cluster randomized trials: A methods comparison.
   Benitez A, Petersen ML, van der Laan MJ, Santos N, et al · · 2023 · cited 14× · PMID 37308115 · DOI 10.1002/sim.9813
4. Pregnancy outcomes in facility deliveries in Kenya and Uganda: A large cross-sectional analysis of maternity registers illuminating opportunities for mortality prevention.
   Waiswa P, Higgins BV, Mubiri P, Kirumbi L, et al · · 2020 · cited 11× · PMID 32479522 · DOI 10.1371/journal.pone.0233845
5. Implementing the WHO Safe Childbirth Checklist modified for preterm birth: lessons learned and experiences from Kenya and Uganda.
   Achola KA, Kajjo D, Santos N, Butrick E, et al · · 2022 · cited 10× · PMID 35241076 · DOI 10.1186/s12913-022-07650-x
6. Implementing an intrapartum package of interventions to improve quality of care to reduce the burden of preterm birth in Kenya and Uganda.
   Namazzi G, Achola KA, Jenny A, Santos N, et al · · 2021 · cited 10× · PMID 33509293 · DOI 10.1186/s43058-021-00109-w
7. Growth and neurodevelopmental outcomes of preterm and low birth weight infants in rural Kenya: a cross-sectional study.
   Martin-Herz SP, Otieno P, Laanoi GM, Moshi V, et al · · 2023 · cited 5× · PMID 37652593 · DOI 10.1136/bmjopen-2022-064678
8. 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.
   Mandu R, Miller L, Namazzi G, Twum-Danso N, et al · · 2023 · cited 3× · PMID 38135302 · DOI 10.1136/bmjoq-2023-002443