NCT03254628

Brief Summary

The study aims are to evaluate the impact of supportive follow-up strategies for a novel twinned training and capacity-sustaining program among frontline health workers (providers) attending facility-based births in remote and district level health facilities in Uganda. The program is designed to improve provider competencies, provider performance and health outcomes among women giving birth and newborns.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,440

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 14, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 18, 2017

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

2.1 years

First QC Date

July 20, 2017

Last Update Submit

August 18, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Difference in differences: change in use of oxytocin for prevention of postpartum hemorrhage

    The change in the percentage of women who received oxytocin in correct dose immediately after vaginal birth in three study arms, as assessed by direct clinical observation, using a standardized checklist.

    Baseline, Midline (6 months), Endline (12 months)

Secondary Outcomes (3)

  • Change in provider performance on simulator-based assessments

    Pre-test (before training)- post-test (immediately after training) - midline (6 months)

  • Difference in differences: change in care of the mother composite score

    Baseline (before training), Midline (6 months), Endline (12 months)

  • Difference in differences: change care of the newborn composite score

    Baseline (before training), Midline (6 months), Endline (12 months)

Study Arms (3)

Full - Train/oxy&miso/ B&M/Mentor/Phone

EXPERIMENTAL

Helping Mothers Survive- Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask, designation of Clinical Mentor in each facility to support deliberate practice, phone-based support from district trainer for Clinical Mentor.

Other: Helping Mothers Survive - Bleeding After Birth trainingOther: Helping Babies BreatheBehavioral: MentorBehavioral: PhoneDrug: oxytocin and misoprostolDevice: Newborn bag and mask

Partial - Train/oxy & miso/ B&M/Mentor

EXPERIMENTAL

Helping Mothers Survive - Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask, designation of clinical mentor in each facility to support deliberate practice.

Other: Helping Mothers Survive - Bleeding After Birth trainingOther: Helping Babies BreatheBehavioral: MentorDrug: oxytocin and misoprostolDevice: Newborn bag and mask

Comparison - Train/oxy & miso/ B&M

ACTIVE COMPARATOR

Helping Mothers Survive - Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask,.

Other: Helping Mothers Survive - Bleeding After Birth trainingOther: Helping Babies BreatheDrug: oxytocin and misoprostolDevice: Newborn bag and mask

Interventions

One-day training in postpartum hemorrhage prevention and treatment; this includes instruction to provide oxytocin within one minute of birth to prevent postpartum hemorrhage.

Also known as: HMS BAB
Comparison - Train/oxy & miso/ B&MFull - Train/oxy&miso/ B&M/Mentor/PhonePartial - Train/oxy & miso/ B&M/Mentor

One-day training in neonatal asphyxia management; this includes routine care for the newborn, such as drying and stimulation immediately after birth, and resuscitation of asphyxiated newborns using a bag \& mask device.

Also known as: HBB
Comparison - Train/oxy & miso/ B&MFull - Train/oxy&miso/ B&M/Mentor/PhonePartial - Train/oxy & miso/ B&M/Mentor
MentorBEHAVIORAL

A birth attendant in the facility is designated as a clinical mentor and encouraged to lead simulator-based practice sessions in the facility after training day.

Also known as: CM
Full - Train/oxy&miso/ B&M/Mentor/PhonePartial - Train/oxy & miso/ B&M/Mentor
PhoneBEHAVIORAL

District trainers telephone clinical mentors and encourage them to lead practice sessions.

Full - Train/oxy&miso/ B&M/Mentor/Phone

This study did not provide uterotonic drugs except in the case of stock out where locally purchased oxytocin and misoprostol were provided only as back up.

Also known as: oxy&miso
Comparison - Train/oxy & miso/ B&MFull - Train/oxy&miso/ B&M/Mentor/PhonePartial - Train/oxy & miso/ B&M/Mentor

All facilities were supplied with at least 1 bag and mask for newborn resuscitation. This bag and mask was used for training, practice, and clinical care

Also known as: B&M
Comparison - Train/oxy & miso/ B&MFull - Train/oxy&miso/ B&M/Mentor/PhonePartial - Train/oxy & miso/ B&M/Mentor

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • For Providers: Health providers who attend births in participating health facility and consent to be assessed at the time of enrollment and at several points in time over two years.
  • For Clinical mentors: being an experienced skilled birth attendant and likely to remain at the facility during the study period
  • For Women in Labor and Delivery and Newborns: Women in any stage of labor in participating facility who consent to observation of their delivery and care of their newborn (or consent from the next of kin if the woman is incapacitated and not able to provide consent)
  • Facility In-charges and Stakeholders: Facility in-charges at sampled health facilities; stakeholders identified by Jhpiego senior managers as being influential in maternal and newborn health policy decisions in Uganda.

You may not qualify if:

  • Providers: has \<1 year of experience, and has plans to be transferred to another facility or leave the facility soon
  • Other types of participants: none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Williams E, Bazant ES, Holcombe S, Atukunda I, Namugerwa RI, Britt K, Evans C. "Practice so that the skill does not disappear": mixed methods evaluation of simulator-based learning for midwives in Uganda. Hum Resour Health. 2019 Mar 29;17(1):24. doi: 10.1186/s12960-019-0350-z.

  • Evans CL, Bazant E, Atukunda I, Williams E, Niermeyer S, Hiner C, Zahn R, Namugerwa R, Mbonye A, Mohan D. Peer-assisted learning after onsite, low-dose, high-frequency training and practice on simulators to prevent and treat postpartum hemorrhage and neonatal asphyxia: A pragmatic trial in 12 districts in Uganda. PLoS One. 2018 Dec 17;13(12):e0207909. doi: 10.1371/journal.pone.0207909. eCollection 2018.

MeSH Terms

Conditions

Postpartum HemorrhageAsphyxia Neonatorum

Interventions

OxytocinMisoprostolMasks

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsProstaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsSurgical AttireEquipment and Supplies, HospitalEquipment and SuppliesProtective DevicesPersonal Protective EquipmentSurgical EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Cherrie Evans, DrPH

    Jhpiego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2017

First Posted

August 18, 2017

Study Start

November 14, 2014

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

August 22, 2017

Record last verified: 2017-08