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Trial record 14 of 3446 for:    Facility

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

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ClinicalTrials.gov Identifier: NCT03112018
Recruitment Status : Completed
First Posted : April 13, 2017
Last Update Posted : June 18, 2019
Sponsor:
Collaborators:
Makerere University
Kenya Medical Research Institute
Information provided by (Responsible Party):
Dilys Walker, University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Pregnancy Complications Preterm Labor PreTerm Birth Stillbirth Low Birth Weight Behavioral: data strengthening Behavioral: modified Safe childbirth checklist - control Behavioral: modified Safe childbirth checklist - enhanced Behavioral: PRONTO training Behavioral: QI cycles Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102988 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Strengthening Intrapartum and Immediate Newborn Care to Reduce Morbidity and Mortality of Preterm Infants in Health Facilities in Migori County, Kenya and Busoga Region, Uganda: an Implementation Science RCT
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : May 31, 2019

Arm Intervention/treatment
Active Comparator: Standard care
  • Data strengthening
  • modified Safe Childbirth Checklist (mSCC) implementation
Behavioral: data strengthening
Data strengthening: initial training, monthly data collection and feedback on data quality, access to dashboards, periodic Data Quality Assessments

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

Experimental: Enhanced care (intervention)
  • Data strengthening
  • modified Safe Childbirth Checklist (mSCC) implementation
  • Health provider training (PRONTO)
  • Quality Improvement (QI) Cycles
Behavioral: data strengthening
Data strengthening: initial training, monthly data collection and feedback on data quality, access to dashboards, periodic Data Quality Assessments

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

Behavioral: PRONTO training
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

Behavioral: QI cycles
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




Primary Outcome Measures :
  1. all-cause neonatal mortality among preterms/low birth weight newborns [ Time Frame: 28-days after facility-based delivery ]
    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


Secondary Outcome Measures :
  1. Data quality of key indicators in facility-based registers [ Time Frame: through study completion, an average of 18 months ]
    Key indicators include gestational age, facility discharge status, preterm birth incidence

  2. Pre-hospital discharge mortality among preterm infants and babies born alive between 500 and 999 grams at birth [ Time Frame: at hospital discharge, an average of 1-7 days ]
  3. 28-day mortality among babies born alive between 500 and 999 grams at birth [ Time Frame: 28-days after facility-based delivery ]
  4. Average number of evidence-based practices demonstrated in simulated case videos and live birth observations [ Time Frame: Baseline and through study completion, an average of 18 months ]
    Uptake and appropriate utilization of evidence-based interventions/ Ministry of Health management guidelines measured in PRONTO simulation videos, observed live births and/or mSCC

  5. Prevalence of preterm birth phenotypes in the study sites as measured by chart review and the mSCC [ Time Frame: Every year over four years ]
  6. Facility readiness to handle delivery and newborn complications as measured by a facility assessment tool [ Time Frame: Every six months over two years ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112018


Locations
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Kenya
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, Kenya
Uganda
Health facilities in Busoga Region: Bugiri, Buluba, Iganga, Kamuli Government, Kamuli Mission, Jinja Regional Referral Hospital
Busoga Region, Uganda
Sponsors and Collaborators
University of California, San Francisco
Makerere University
Kenya Medical Research Institute
Investigators
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Principal Investigator: 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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dilys Walker, Principal Investigator, Preterm Birth Initiative East Africa; University of California, San Francisco, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03112018     History of Changes
Other Study ID Numbers: A123218-K/U
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Dilys Walker, University of California, San Francisco:
premature birth
neonatal mortality
premature infant
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Pregnancy Complications
Stillbirth
Birth Weight
Obstetric Labor Complications
Body Weight
Signs and Symptoms
Fetal Death
Death
Pathologic Processes