NCT04442997

Brief Summary

The purpose of the research study is to collect preliminary data to which future outcomes after implementing quality improvement projects or research will be compared. There will be observation of the labor and delivery services received and resulting outcomes of women and infants who deliver at private health facilities in urban Malawi. Data will be collected at admission, delivery, and discharge from women and providers on patient characteristics, labor and obstetric characteristics, delivery factors, and pregnancy outcomes that result during the course of the hospitalization. This will include the vital status of the mother and the infant. The overall hypothesis is that cesarean birth rates will be higher than the ecologically supported 10% cesarean birth rate, and that there may be cesareans that are performed without clear medical indication.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

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

First Submitted

Initial submission to the registry

June 19, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
1.7 years until next milestone

Study Start

First participant enrolled

February 21, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

4 months

First QC Date

June 19, 2020

Last Update Submit

July 24, 2022

Conditions

Cesarean Section

Keywords

Cesarean sectionCesarean birth

Outcome Measures

Primary Outcomes (2)

  • Rate of participants using cesarean section delivery as assessed by survey questionnaires

    Hospital admission to discharge, about 3-4 days

  • Types of indications for cesarean birth

    Hospital admission to discharge, about 3-4 days

Secondary Outcomes (2)

  • Types of adverse pregnancy outcomes among participants using cesarean section

    Hospital admission to discharge, up to 1 week

  • Types of risk factors for Cesarean birth

    Hospital admission to discharge, about 3-4 days

Eligibility Criteria

Sexfemale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All pregnant women admitted for observation or delivery at 3 private health facilities in Malawi.

You may qualify if:

  • Pregnancy
  • Admitted for delivery or observation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mwaiwathu Private Hospital

Blantyre, Malawi

Location

Area 18 Medi Clinic - Asamala Health Services

Lilongwe, Malawi

Location

Good Hope Private Clinic

Lilongwe, Malawi

Location

Study Officials

  • Margo Harrison, MD, MPH

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2020

First Posted

June 23, 2020

Study Start

February 21, 2022

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

July 27, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

MA(3)