Assessing Childbirth-related Complications at the Community Level in Kenya

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Wilson Liambila, Kenyatta National Hospital
ClinicalTrials.gov Identifier:
NCT01665456
First received: August 9, 2012
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

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.


Condition
Puerperal Sepsis
Postpartum Hemorrhage
Preeclampsia and Eclampsia
Retained Placenta, Without Hemorrhage
Obstructed Labor Due to Breech Presentation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Assessing Childbirth-related Complications at the Community Level in Kenya: A Case Control Study Among Postpartum Women

Resource links provided by NLM:


Further study details as provided by Kenyatta National Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Proportion of women receiving skilled attendance at birth in the community in the past 12 months. [ Time Frame: One Year ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   None Retained

This was a two-arm study (Cases and controls). Random identification of cases through cross-sectional survey was done. Then, a random sample of controls was drawn from the source population from which the cases were selected (i.e. from same study base except that they were not cases) through matching variables i.e. age and location. Individual matching of controls to the characteristics of the cases was done. A total of 585 clients (women) were recruited (294cases and 291 controls).


Enrollment: 585
Study Start Date: August 2012
Study Completion Date: March 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

  Eligibility

Ages Eligible for Study:   15 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665456

Locations
Kenya
Lugari and Bungoma districts
Kakamega, Western Province, Kenya
Sponsors and Collaborators
Wilson Liambila
Merck Sharp & Dohme Corp.
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
  More Information

Additional Information:
Publications:

Responsible Party: Wilson Liambila, Senior Programme Officer, Kenyatta National Hospital
ClinicalTrials.gov Identifier: NCT01665456     History of Changes
Other Study ID Numbers: P141/03/2012
Study First Received: August 9, 2012
Last Updated: April 25, 2014
Health Authority: Kenya: Ethical Review Committee
Kenya: Ministry of Health

Keywords provided by Kenyatta National Hospital:
complications

Additional relevant MeSH terms:
Hemorrhage
Pre-Eclampsia
Postpartum Hemorrhage
Breech Presentation
Placenta, Retained
Dystocia
Pathologic Processes
Hypertension, Pregnancy-Induced
Pregnancy Complications
Obstetric Labor Complications
Puerperal Disorders
Uterine Hemorrhage
Placenta Diseases

ClinicalTrials.gov processed this record on September 30, 2014