Clinical trial NCT04442997: Use of Cesarean Birth at Private Health Facilities in Lilongwe and Blantyre, Malawi
Official title: Use of Cesarean Birth at Private Health Facilities in Lilongwe and Blantyre, Malawi
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Section
Keywords: Cesarean section
Cesarean birth
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 260
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pregnant women admitted for observation or delivery at 3 private health facilities in Malawi.

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

Eligibility criteria: Inclusion Criteria:

* Pregnancy
* Admitted for delivery or observation

Exclusion Criteria:

-

Primary outcomes:
measure: Rate of participants using cesarean section delivery as assessed by survey questionnaires
timeFrame: Hospital admission to discharge, about 3-4 days
measure: Types of indications for cesarean birth
timeFrame: Hospital admission to discharge, about 3-4 days
Secondary outcomes:
measure: Types of adverse pregnancy outcomes among participants using cesarean section
timeFrame: Hospital admission to discharge, up to 1 week
measure: Types of risk factors for Cesarean birth
timeFrame: Hospital admission to discharge, about 3-4 days
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: Mwaiwathu Private Hospital
city: Lilongwe
country: Malawi
facility: Area 18 Medi Clinic - Asamala Health Services
city: Lilongwe
country: Malawi
facility: Good Hope Private Clinic
Study officials:
affiliation: University of Colorado, Denver
name: Margo Harrison, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: