Use of Cesarean Birth at Private Health Facilities in Lilongwe and Blantyre, Malawi

NCT ID: NCT04442997

Last Updated: 2022-07-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 260 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-21
• Study Completion Date: 2022-06-30

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.

Detailed Description

Background:

Cesarean birth is the most commonly performed surgery in the world. It is a major abdominal procedure that can save maternal and perinatal lives when properly indicated, but when performed without medical necessity, is associated with adverse outcomes. Global cesarean birth rates are increasing, but there has been a less pronounced rise in sub-Saharan Africa (SSA) where rates tend to be below 5.0%. However, in Sub-Saharan Africa (SSA) and other low- and middle-income countries (LMIC), there is a recognition that significant in-country disparities in the use of cesarean birth exist. Rates are higher in urban settings, and there is evidence that they are higher in private versus public facilities.

Objective and Aims:

The main objective of this prospective, cross-sectional, observational study is to observe the use of cesarean birth at three private health facilities in urban Malawi by the end of the study. This will be achieved by getting an understanding of the current delivery practices and patient characteristics, as well as associated outcomes of women who choose to deliver at these private facilities in order to understand how and under what circumstances the surgery is being used.

Aim 1: Observe prevalence of and indications for cesarean birth in three private health facilities in urban Malawi in the overall cohort and in ten mutually exclusive subgroups defined by the WHO-endorsed Robson Classification for cesarean birth

Aim 2: Determine risk factors associated with cesarean birth among Robson subpopulations of women at study sites, and the distribution of adverse pregnancy outcomes across those subgroups

Aim 3: Identify target modifiable risk factors or areas for potential quality improvement or prospective research studies to optimize the use of cesarean birth within these facilities that may have generalizable implications

Conditions

Cesarean Section

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Pregnancy
• Admitted for delivery or observation

Exclusion Criteria

-

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margo Harrison, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Mwaiwathu Private Hospital

Blantyre, , Malawi

Area 18 Medi Clinic - Asamala Health Services

Lilongwe, , Malawi

Good Hope Private Clinic

Lilongwe, , Malawi

Countries

Malawi

Other Identifiers

NICHD/K12 HD001271-21

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20-0468

Identifier Type: -

Identifier Source: org_study_id