Assessing Childbirth-related Complications at the Community Level in Kenya

This study is not yet open for participant recruitment.
Verified August 2012 by Kenyatta National Hospital
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: August 14, 2012
Last verified: August 2012
  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 will be the primary outcome measure of association between the the occurrence complications and exposure to health providers in the past 12 months. [ Time Frame: One Year ] [ Designated as safety issue: No ]
    The study seeks 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 Kenya in the past 12 months.The odds of exposure among cases will be compared to the odds of exposure among controls to find out whether there is association between exposure to health providers and occurrence of complications or disease.


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 will be 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 one hour 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 will be captured on the proportion of pregnant women in labour or in the postpartum period who were referred within an hour by health care providers 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 will be a two-arm study (Cases and controls). Random identification of cases through cross-sectional survey will be. Then, a random sample of controls is drawn from the source population from which the cases were selected (i.e. from same study base except that they are not cases) through matching variables e.g. age and other demographic and socio-economic factors. Individual matching of controls to match the overall characteristics of the cases. A total of 550 women will be recruited (275 in each arm).


Estimated Enrollment: 550
Study Start Date: October 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cases (women with complications)
Cases are women aged 15-49 years who delivered within the past 12 months and faced a complication that either necessitated treatment, hospitalization in order to prevent the likelihood of death of the mother or who survived by chance.
Control (women who did not experience any complications)
Controls are women aged 15-49 years who delivered within the past 12 months but did not have or develop any of the complications which cases experienced or suffered from.Although controls will not have the disease condition, they will be individually matched on the basis of socio-economic and demographic profile such as income, age, location, education level and marital status etc. Controls will be individually matched with cases for these factors. The idea is 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 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. A woman aged 15-49 years with a delivery in the past 12 months who report having experienced no complication during child-birth will be recruited as a control.

Criteria

Case Inclusion criteria:

  • Delivery in the past 12 months
  • Suffered from obstetric complications during child birth and within 42days
  • Provides 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
  • Provides 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;
  • Refusal 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01665456

Contacts
Contact: Shiphrah N. Kuria, MB ChB, MMed (OBGYN) +254722300279 ext - shiphonk@yahoo.com
Contact: Wilson N. Liambila, MSc +254202713480 ext 148 wliambila@popcouncil.org; liambilawilson@yahoo.co.uk

Locations
Kenya
Lugari and Bungoma districts Not yet recruiting
Kakamega, Western Province, Kenya
Contact: Assumpta A. Matekwa, MPH    +254724270308 ext -    assumatekwa@yahoo.com   
Contact: Jane I. Makona, KRCHN    +254743367400 ext -    grissie07@yahoo.com   
Sub-Investigator: Assumpta A. Matekwa, MPH         
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: August 14, 2012
Health Authority: Kenya: Ethical Review Committee
Kenya: Ministry of Health

Keywords provided by Kenyatta National Hospital:
complications

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

ClinicalTrials.gov processed this record on April 16, 2014