Clinical trial NCT01665456: Assessing Childbirth-related Complications at the Community Level in Kenya
Official title: Assessing Childbirth-related Complications at the Community Level in Kenya: A Case Control Study Among Postpartum Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Puerperal Sepsis
Postpartum Hemorrhage
Preeclampsia and Eclampsia
Retained Placenta, Without Hemorrhage
Obstructed Labor Due to Breech Presentation
Keywords: complications
Lead sponsor: Kenyatta National Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2012-08-15
Enrollment: 585
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.

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 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

Primary outcomes:
measure: 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.
timeFrame: One Year
Secondary outcomes:
measure: Proportion of women receiving skilled attendance at birth in the community in the past 12 months.
timeFrame: One Year
Other outcomes:
measure: 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.
timeFrame: One Year
Locations:
city: Kakamega
country: Kenya
facility: Lugari and Bungoma districts
state: Western Province
Study officials:
affiliation: Division of Reproductive Health- Ministry of Public Health and Sanitation
name: Shiphrah N. Kuria, MB ChB, MMed (OBGYN)
role: PRINCIPAL_INVESTIGATOR
affiliation: Population Council
name: Wilson N. Liambila, MSc
role: PRINCIPAL_INVESTIGATOR
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