Completed

Assessing Childbirth-related Complications at the Community Level in Kenya: A Case Control Study Among Postpartum Women

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What is being collected

Data Collection

Collected from past medical records and data - Retrospective
No Sample Retained
Who is being recruted

Urogenital Diseases+15

+ Female Urogenital Diseases and Pregnancy Complications

+ Hemorrhage

From 15 to 49 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: August 2012
See protocol details

Summary

Principal SponsorWilson Liambila
Last updated: April 28, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

Evidence from published literature is scanty on the effect of various categories of health providers in averting serious child birth related complications at the community level. For instance, no one knows what happens to pregnancy outcomes for both the mother and the baby in a context where a significant proportion of women are delivered by neighbors, relatives or on their own. Literature is also scanty regarding the outcomes of child birth related complications in situations where Traditional Birth Attendants conduct a significant proportion of deliveries. A thorough understanding of factors that fuel disrespect and abuse as well as their effect on utilization of delivery services will help providers and programme managers to explore ways of addressing this issue. This study hypothesizes that since majority of deliveries take place at the household level, most complications and even deaths are likely to occur at this level. The overall objective of this study is to determine the effect of provider type in the occurrence and management of serious childbirth related complications among postpartum women at the community level in Bungoma and Lugari Districts of Western Province, Kenya. Specific objectives of the study are: To determine the quality of obstetric care given by community midwives and TBAs to clients seeking antenatal care, during delivery and post-partum care at the community level by assessing providers' preparedness and the range of services offered. To assess the nature of obstetric complications among those women who were delivered by skilled health providers, versus those who were delivered by TBAs, neighbors, friends or on their own To determine the role of socio-economic, demographic and health service related factors in the occurrence of child birth related complications at the community level To obtain views from key stakeholders on the extent and occurrence of child birth related complications at the community level

Principal SponsorWilson Liambila
Last updated: April 28, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

585 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 15 to 49 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsHemorrhageInfectionsObstetric Labor ComplicationsPathologic ProcessesPlacenta DiseasesPregnancy ComplicationsPregnancy Complications, InfectiousPuerperal DisordersPathological Conditions, Signs and SymptomsUterine HemorrhageHypertension, Pregnancy-InducedEclampsiaPostpartum HemorrhagePre-EclampsiaPuerperal InfectionPlacenta, Retained

Criteria

5 exclusion criteria prevent from participating
Did not deliver in the past 12 months

Excluded as cases if they didnot experience complications

Excluded as controls if experienced complications similar to cases

If unable to give informed consent or follow an interview

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Lugari and Bungoma districts

Kakamega, KenyaOpen Lugari and Bungoma districts in Google Maps
CompletedOne Study Center