Assessing Childbirth-related Complications at the Community Level in Kenya

NCT01665456 | Completed DMC

• 1 other identifier: P141/03/2012
• Study Type: observational
• Target: 585
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

complications

Outcome Measures

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.

  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 Outcomes (1)

• Proportion of women receiving skilled attendance at birth in the community in the past 12 months.

  One Year

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.

  One Year

Study Arms (2)

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.

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wilson Liambila: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Lugari and Bungoma districts

Kakamega, Western Province, Kenya

Location

Related Publications (10)

• Brennan M. Training traditional birth attendants reduces maternal mortality and morbidity. Trop J Obstet Gynaecol. 1988;1(1):44-7.

  PMID: 12179276 BACKGROUND

• Koblinsky MA, Tinker A, Daly P. Programming for safe motherhood: a guide to action. Health Policy Plan. 1994 Sep;9(3):252-66. doi: 10.1093/heapol/9.3.252.

  PMID: 10137741 RESULT

• Bisika T. The effectiveness of the TBA programme in reducing maternal mortality and morbidity in Malawi. East Afr J Public Health. 2008 Aug;5(2):103-10.

  PMID: 19024419 RESULT

• Magoma M, Requejo J, Campbell OM, Cousens S, Filippi V. High ANC coverage and low skilled attendance in a rural Tanzanian district: a case for implementing a birth plan intervention. BMC Pregnancy Childbirth. 2010 Mar 19;10:13. doi: 10.1186/1471-2393-10-13.

  PMID: 20302625 RESULT

• Knol MJ, Vandenbroucke JP, Scott P, Egger M. What do case-control studies estimate? Survey of methods and assumptions in published case-control research. Am J Epidemiol. 2008 Nov 1;168(9):1073-81. doi: 10.1093/aje/kwn217. Epub 2008 Sep 15.

  PMID: 18794220 RESULT

• Mushi D, Mpembeni R, Jahn A. Effectiveness of community based Safe Motherhood promoters in improving the utilization of obstetric care. The case of Mtwara Rural District in Tanzania. BMC Pregnancy Childbirth. 2010 Apr 1;10:14. doi: 10.1186/1471-2393-10-14.

  PMID: 20359341 RESULT

• Thatte N, Mullany LC, Khatry SK, Katz J, Tielsch JM, Darmstadt GL. Traditional birth attendants in rural Nepal: knowledge, attitudes and practices about maternal and newborn health. Glob Public Health. 2009;4(6):600-17. doi: 10.1080/17441690802472406.

  PMID: 19431006 RESULT

• Kwast BE. Reduction of maternal and perinatal mortality in rural and peri-urban settings: what works? Eur J Obstet Gynecol Reprod Biol. 1996 Oct;69(1):47-53. doi: 10.1016/0301-2115(95)02535-9.

  PMID: 8909956 RESULT

• Maine D, Akalin MZ, Chakraborty J, de Francisco A, Strong M. Why did maternal mortality decline in Matlab? Stud Fam Plann. 1996 Jul-Aug;27(4):179-87.

  PMID: 8875731 RESULT

• Rodrigues L, Kirkwood BR. Case-control designs in the study of common diseases: updates on the demise of the rare disease assumption and the choice of sampling scheme for controls. Int J Epidemiol. 1990 Mar;19(1):205-13. doi: 10.1093/ije/19.1.205.

  PMID: 2190942 RESULT

Related Links

• http://www.uonbi.ac.ke/activities/KNHUoN
• http://www.popcouncil.org/pdfs/2012RH\_APHIAII\_CommunityMidwifery.pdf

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).

MeSH Terms

Conditions

Puerperal Infection; Postpartum Hemorrhage; Pre-Eclampsia; Eclampsia; Placenta, Retained

Condition Hierarchy (Ancestors)

Pregnancy Complications, Infectious; Infections; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Obstetric Labor Complications; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension, Pregnancy-Induced; Placenta Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Programme Officer

Study Record Dates

• First Submitted: August 9, 2012
• First Posted: August 15, 2012
• Study Start: August 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: March 1, 2014
• Last Updated: April 28, 2014

Record last verified: 2014-04

Locations

KE (1)