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

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04442997
• Other study ID #: 20-0468
• Secondary ID: NICHD/K12 HD0012
• Status: Completed
• Start date: February 21, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pregnancy
• Admitted for delivery or observation Exclusion Criteria: -

Related Conditions & MeSH terms

• Cesarean Section

Locations

Country	Name	City	State
Malawi	Mwaiwathu Private Hospital	Blantyre
Malawi	Area 18 Medi Clinic - Asamala Health Services	Lilongwe
Malawi	Good Hope Private Clinic	Lilongwe

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of participants using cesarean section delivery as assessed by survey questionnaires		Hospital admission to discharge, about 3-4 days
Primary	Types of indications for cesarean birth		Hospital admission to discharge, about 3-4 days
Secondary	Types of adverse pregnancy outcomes among participants using cesarean section	The types of adverse pregnancy outcomes reported among participants with cesarean section deliveries will be assessed via survey questionnaires. Data will be reported by population subgroup. Population subgroups will be defined by the World Health Organization-endorsed Robson Classification for Cesarean Birth	Hospital admission to discharge, up to 1 week
Secondary	Types of risk factors for Cesarean birth	The types of modifiable risk factors for cesarean birth reported among participants that use cesarean section delivery will be assessed via survey questionnaires	Hospital admission to discharge, about 3-4 days