Skip to main content
OpenTrials
Completed

NCT Number: NCT01665456

Assessing Childbirth-related Complications at the Community Level in Kenya

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Puerperal Sepsis Eclampsia Female Urogenital Diseases and Pregnancy Complications Hemorrhage Hypertension, Pregnancy-Induced Infections Obstetric Labor Complications Obstructed Labor Due to Breech Presentation Pathologic Processes Pathological Conditions, Signs and Symptoms Placenta Diseases Placenta, Retained Postpartum Hemorrhage Pre-Eclampsia Preeclampsia and Eclampsia Pregnancy Complications Pregnancy Complications, Infectious Puerperal Disorders Puerperal Infection Retained Placenta, Without Hemorrhage Urogenital Diseases Uterine Hemorrhage

Age range

15 year–49 year

Sex eligibility

Female

Study type

Observational

Primary location

Lugari and Bungoma districts

Kakamega, Western Province, Kenya

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Wilson Liambila

Other Gov

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Aug 15, 2012
Registry last updated
Apr 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.