Assessing Childbirth-related Complications at the Community Level in Kenya

April 25, 2014 updated by: Wilson Liambila

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

Kenya is one of the countries in sub-Saharan Africa that still experience high maternal mortality. For instance, in 2008/09 maternal mortality ratio was estimated to be 488/100,000 live births. Direct obstetric complications such as puerperal sepsis, postpartum hemorrhage, pre-eclampsia and eclampsia, obstructed labor and indirect causes including HIV, malaria and anemia in pregnancy are responsible for the majority of these cases. Just under 44% of births in Kenya are delivered under the supervision of a skilled birth attendant.

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.

The proposed study will employ a case control study design in which women with obstetric complication(s)will be cases and women without obstetric complications will be controls. Controls will be sampled concurrently with the cases. Each time a new case is diagnosed, a control is selected from the population at risk in the neighborhood at that point in time.

The study population will consist of women aged 15-49 years with a delivery in the past 12 months. A woman who reports having experienced a birth-related complication will be recruited as a case while woman who reports having experienced no complication during child-birth will be recruited as a control.

Study Overview

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

585

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Western Province
      • Kakamega, Western Province, Kenya
        • Lugari and Bungoma districts

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 49 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

The study population consisted of women aged 15-49 years with a delivery within 12 months preceding data collection date. A woman who reported having experienced a birth-related complication was recruited as a case. A woman aged 15-49 years with a delivery within 12 months preceding data collection who report having experienced no complication during child-birth was recruited as a control.

Description

Case Inclusion criteria:

  • Delivery in the past 12 months
  • Suffered from obstetric complications during child birth and within 42days
  • Provided oral or written informed consent to participate in the study
  • Age ranges 15-49 years

Control inclusion criteria

  • Delivered in the past 12 months
  • Did not suffer from obstetric complications during child birth and within 42 days after delivery
  • Provided oral or written informed consent to participate in the study
  • Age ranges 15-49 years

Case and Control exclusion criteria:

  • Did not deliver in the past 12 months;
  • Refused to participate in the study;
  • Excluded as controls if experienced complications similar to cases
  • Excluded as cases if they didnot experience complications
  • If unable to give informed consent or follow an interview

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cases (women with complications)
Cases are women aged 15-49 years who delivered within 12 months prior to data collection and had experienced obstetric complication(s) that either necessitated treatment or hospitalization in order to prevent the likelihood of death of the mother.
Control (women who did not experience any complications)
Controls are women aged 15-49 years who delivered within 12 months prior to data collection. They did not have or develop any of the complications which cases experienced or suffered from.Although controls did not have complications, they were individually matched on the basis of age and location. The idea was to compare how many cases were exposed versus how many controls were exposed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The odds ratio was the primary outcome measure of association between the the occurrence of complications and exposure to health providers in the past 12 months.
Time Frame: One Year
The study sought to determine the association of provider type with the occurrence and management of serious childbirth related complications among postpartum women at the community level in Kenya in the past 12 months.The odds of exposure among cases were compared to the odds of exposure among controls to estimate the magnitude of association between exposure to health providers and other caregivers and the occurrence of complications.
One Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of women receiving skilled attendance at birth in the community in the past 12 months.
Time Frame: One Year
This secondary outcome measure was assessed by collecting information on the nature of obstetric complications among those women who were delivered by skilled health providers, versus those who were delivered by Traditional Birth attendants, neighbours, friends or delivered on their own.
One Year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of women with obstetric complications reporting to have been referred within 0-4 hours and 5-8 hours of admission or assessment to another level of care in the past 12 months.
Time Frame: One Year
Prompt referral of women with obstetric complications is critical to their survival.Data was captured on the proportion of pregnant women in labour or in the postpartum period who were referred within 0-4hours and 5-8hours by health care providers or other care givers at the community level to the next level of care or the nearest health facilities after assessing or examining them.
One Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Principal Investigator: Shiphrah N. Kuria, MB ChB, MMed (OBGYN), Division of Reproductive Health- Ministry of Public Health and Sanitation
  • Principal Investigator: Wilson N. Liambila, MSc, Population Council

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

August 9, 2012

First Submitted That Met QC Criteria

August 14, 2012

First Posted (Estimate)

August 15, 2012

Study Record Updates

Last Update Posted (Estimate)

April 28, 2014

Last Update Submitted That Met QC Criteria

April 25, 2014

Last Verified

April 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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