Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03363308
Other study ID # OPP1156220
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 16, 2017
Est. completion date June 30, 2020

Study information

Verified date July 2020
Source Jhpiego
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The health workforce capacity building and quality improvement intervention will be implemented in two phases: eight facilities will receive the intervention in phase 1 and the remaining eight facilities will receive the intervention in phase 2.

Objective 1: For objective 2 on facility-based health outcomes, the study design is a cluster-randomized evaluation in phase 1. The intervention's effects will be assessed by comparing an intervention group and a control group of facilities. These will be selected from 16 Kinshasa health facilities. Intervention and control facilities' monthly reported health outcomes will be compared in a 12-month baseline period and 12-month period during and after the intervention implementation (Phase 1) in a difference-in-difference analysis. In Phase 2, all facilities will have their monthly service statistics and health outcomes reviewed for trends in improvement.

Overall, in Phase 1, eight intervention sites will be matched to eight sites serving as controls. In Phase 2, the eight Phase 1 control sites will then receive the same package as the intervention sites in Phase 1. Sites will be stratified by case load, low and high (over 90 births per month), and funding (public or private funding). Within each stratum, prior to start of the intervention, there will be random selection to intervention and control groups to allow for baseline comparability between groups.


Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date June 30, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- there are no exclusion criteria

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
training for health care workers supplmented by QI teams
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.

Locations

Country Name City State
Congo, The Democratic Republic of the Jhpiego DRC Kinshasa

Sponsors (2)

Lead Sponsor Collaborator
Jhpiego Bill and Melinda Gates Foundation

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 maternal mortality number of maternal deaths over number of live births 3 days
See also
  Status Clinical Trial Phase
Recruiting NCT03605511 - TTP and aHUS in Complicated Pregnancies
Completed NCT02379728 - Ghana PrenaBelt Trial: A Positional Therapy Device to Reduce Still-Birth N/A
Not yet recruiting NCT01664546 - Study of the Best Blastocyst Post Transfer by aCGH N/A
Completed NCT02218931 - ESTEEM - Effect of Simple, Targeted Diet in Pregnant Women With Metabolic Risk Factors on Pregnancy Outcomes N/A
Recruiting NCT03662178 - Investigating the Structured Use of Ultrasound Scanning for Fetal Growth
Completed NCT03290924 - Accelerating Newborn Survival in Ghana Through a Low-dose, High-frequency Health Worker Training Approach N/A
Recruiting NCT05901688 - Umbilical Cord Abnormalities in the Prediction of Adverse Pregnancy Outcomes
Completed NCT02339077 - Group B Streptococcus (GBS) Associated Stillbirths in a High Burden Setting
Completed NCT03112018 - Strengthening Facility-based Intrapartum/Immediate Newborn Care to Reduce Mortality of Preterm Infants in Migori County, Kenya and Busoga Region, Uganda N/A
Completed NCT02862925 - Introducing Fetal Scalp Stimulation as an Adjunct to Intermittent Auscultation in Low-Resource Settings. N/A
Completed NCT02318420 - The PartoMa Project: For Improving Monitoring, Action and Triage During Labour N/A
Recruiting NCT05757167 - Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics Phase 4
Completed NCT02148952 - BetterBirth: A Trial of the WHO Safe Childbirth Checklist Program N/A
Active, not recruiting NCT01995968 - Antenatal Detection of Fetal Growth Restriction and Stillbirths Rate. N/A
Completed NCT00270530 - Intermittent Preventive Treatment of Malaria in HIV-Seropositive Pregnant Women in Zambia Phase 4
Completed NCT04600076 - MOMSonLINE2 ; A Pilot Study Testing Recruitment and Retention of Women of Color to an Online Support Group for Bereaved Mothers N/A
Completed NCT03722615 - Epidemiology of Congenital Cytomegalovirus in a High HIV Prevalence Setting, South Africa
Completed NCT02907242 - Revealed Versus Concealed Cerebroplacental Ratio N/A
Recruiting NCT02336243 - A Randomized Trial of Docosahexaenoic Acid Supplementation During Pregnancy to Prevent Deep Placentation Disorders Phase 3
Completed NCT00133744 - Impact of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality Phase 3