Puerperal SepsisNCT01665456
Assessing Childbirth-related Complications at the Community Level in Kenya
An observational study of Puerperal Sepsis and Postpartum Hemorrhage, run by Wilson Liambila at 1 site in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Puerperal Sepsis, Postpartum Hemorrhage, Preeclampsia and Eclampsia
- How many people
- 585 participants
- Where
- 1 siteKenya
- Study dates
- Aug 2012to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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.
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing Childbirth-related Complications at the Community Level in Kenya: A Case Control Study Among Postpartum Women
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.
Read more
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.
Read the 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
- Conditions
- Puerperal Sepsis, Postpartum Hemorrhage, Preeclampsia and Eclampsia, Retained Placenta, Without Hemorrhage, Obstructed Labor Due to Breech Presentation
- Keywords
- complications
- Medical subject headings
- Puerperal Infection, Postpartum Hemorrhage, Pre-Eclampsia, Eclampsia, Placenta, Retained
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One Year
Secondary outcomes (1)
Proportion of women receiving skilled attendance at birth in the community in the past 12 months.
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.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionNov 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Puerperal SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 585 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wilson Liambila
- Sponsor type
- Other government
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Wilson Liambila, Kenyatta National Hospital
- Investigators
- Shiphrah N. Kuria, MB ChB, MMed (OBGYN), Principal investigator, Division of Reproductive Health- Ministry of Public Health and SanitationWilson N. Liambila, MSc, Principal investigator, Population Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665456
- Sponsor's protocol ID
- P141/03/2012
- Status last verified
- Apr 2014
- First submitted
- 9 Aug 2012
- Last updated
- 28 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brennan M. Training traditional birth attendants reduces maternal mortality and morbidity. Trop J Obstet Gynaecol. 1988;1(1):44-7.
PubMed 12179276Koblinsky 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.
PubMed 10137741Bisika 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.
PubMed 19024419Magoma 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.
PubMed 20302625Knol 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.
PubMed 18794220Mushi 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.
PubMed 20359341Thatte 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.
PubMed 19431006Kwast 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.
PubMed 8909956Maine 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.
PubMed 8875731Rodrigues 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.
PubMed 2190942
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Childbirth-related Complications at the Community Level in Kenya: A Case Control Study Among Postpartum Women
- ClinicalTrials.gov ID
- NCT01665456
- Acronym / sponsor ID
- P141/03/2012
- Conditions
- Puerperal Sepsis, Postpartum Hemorrhage, Preeclampsia and Eclampsia, Retained Placenta, Without Hemorrhage, Obstructed Labor Due to Breech Presentation
- Keywords
- complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 585 participants (actual)
- Lead sponsor
- Wilson LiambilaOther government
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Aug 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 15 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Proportion of women receiving skilled attendance at birth in the community in the past 12 months.
Time frame: One Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2014.
- Background: PubMed 12179276Brennan M. Training traditional birth attendants reduces maternal mortality and morbidity. Trop J Obstet Gynaecol. 1988;1(1):44-7.
- Results publication: PubMed 10137741Koblinsky 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.
- Results publication: PubMed 19024419Bisika 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.
- Results publication: PubMed 20302625Magoma 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.
- Results publication: PubMed 18794220Knol 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.
- Results publication: PubMed 20359341Mushi 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.
- Results publication: PubMed 19431006Thatte 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.
- Results publication: PubMed 8909956Kwast 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.
- Results publication: PubMed 8875731Maine 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.
- Results publication: PubMed 2190942Rodrigues 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.
- http://www.uonbi.ac.ke/activities/KNHUoNLink provided by the sponsor.
- http://www.popcouncil.org/pdfs/2012RH\_APHIAII\_CommunityMidwifery.pdfLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiphrah N. Kuria, MB ChB, MMed (OBGYN) principal investigator
Division of Reproductive Health- Ministry of Public Health and Sanitation
Wilson N. Liambila, MSc principal investigator
Population Council
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Puerperal Sepsis and Postpartum Hemorrhage, run by Wilson Liambila at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01665456, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2014; AzTrials last refreshed its copy on 7 Nov 2026.