NCT03363308

Brief Summary

The aim of the study is to evaluate a health workforce capacity building and quality improvement intervention focused on integrated day-of-birth and post-pregnancy care at 16 hospitals in Kinshasa, Democratic Republic of Congo. The intervention package consists of a low-dose, high-frequency (LDHF) training of health workers, support for quality improvement teams, and provision of critical equipment, supplies and drugs within a quality improvement (QI) framework.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 16, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 6, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

July 24, 2020

Status Verified

July 1, 2020

Enrollment Period

2.6 years

First QC Date

November 30, 2017

Last Update Submit

July 22, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • Mean number or percent of items correctly answered

    Each observed structured clinical exam (OSCE) or knowledge tests has between 13 and 38 items. A participant needs to achieve 85% correct score to pass at post-training to assess provider competencies. The main indicator for analysis will be the mean number of items (or percent of items) correctly answered. This mean percent of items correctly answered will be done pre-training, post-training and after 6 months. This will be done in the 8 intervention group facilities only in Phase I and again in the 8 new facilities in Phase II.

    1 day

  • Intrapartum perinatal death ratio

    Defined as death of a fetus during labor who had heart tones documented on arrival in the maternity and neonatal deaths prior to 24 hours, divided by total births.

    1 day

  • Percent of women after childbirth who adopt a family planning method immediately post-pregnancy or intend to adopt a method by six weeks post-pregnancy.

    Percent of women after childbirth who adopt a family planning method over all women who give birth in a facility

    3 days

Secondary Outcomes (1)

  • maternal mortality

    3 days

Study Arms (2)

Phase 1

EXPERIMENTAL

training for health care workers supplemented by QI teams

Behavioral: training for health care workers supplmented by QI teams

Phase 2

NO INTERVENTION

Interventions

Jhpiego will deliver maternal and newborn health and family planning (MNH+FP) training using evidence-based low-dose, high-frequency (LDHF) learning approaches and support hospital staff-led quality improvement efforts to increase the coverage of facility-based high-impact interventions, including care of the mother and newborn on the day of birth and through the first week postpartum and post abortion services.

Also known as: Practice coordinator training after training session, Practice sessions using anatomic models, SMS reminder messages and quizzes, Routine calls between mentors and providers, Health information officer training, Data collection and use training, Supply of simulators, equipment, kits and other, Develop quality improvement teams and review of action plans, Routine calls between project staff and mentors
Phase 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Health providers:
  • Currently on the roster of maternity ward providers working at one of the 16 selected facilities at the time of the training module.
  • Willing to attend a Jhpiego clinical training workshop and offer consent as study participant.
  • Age 18 or older.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jhpiego DRC

Kinshasa, Democratic Republic of the Congo

Location

MeSH Terms

Conditions

Maternal DeathInfant DeathStillbirth

Interventions

Data CollectionEquipment and Supplies

Condition Hierarchy (Ancestors)

Parental DeathDeathPathologic ProcessesPathological Conditions, Signs and SymptomsFetal DeathPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Virgile Kikaya

    Jhpiego DRC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This is a cluster-randomized trial in phase I and interrupted time series in phase II
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2017

First Posted

December 6, 2017

Study Start

November 16, 2017

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

July 24, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations