Evaluation of the Effects of Community-based Interventions
|First Received Date ICMJE||September 12, 2005|
|Last Updated Date||July 13, 2009|
|Start Date ICMJE||April 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00198731 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Evaluation of the Effects of Community-based Interventions|
|Official Title ICMJE||Evaluation of the Effects of Community-based Interventions on Maternal Morbidity in the Early Postpartum Period in Rural Bangladesh|
|Brief Summary||Maternal death is a substantial burden in developing countries. In Bangladesh, recent studies have suggested that a large proportion of women giving birth in rural areas experience pregnancy and delivery related complications. This study, which is set in context where home-birth is the norm, provides the opportunity to provide descriptive information on the self-reported prevalence of maternal behaviors and morbidities during pregnancy, delivery and postpartum periods and to quantify the effects of provision of maternal care interventions through trained community health workers on a few selected maternal behaviors and morbidities.|
Maternal mortality is a substantial burden in developing countries. The World Health Organization (WHO) estimates that between 500,000 to 600,000 women die from complications related to pregnancy and childbirth each year, with 99% of these deaths occurring in developing countries (WHO/UNICEF/UNFPA, 2000). It is estimated that pregnancy-related causes result in about one-quarter to one-third of the deaths of women in their reproductive years (Koblinsky, 1995). Improving maternal mortality has received recognition at the global level as evidenced by the inclusion of reducing maternal mortality in the Millennium Development Goals (United Nations, 2004).
Among problems experienced by women related to child-bearing, maternal mortality is the "tip of the iceberg". Consideration of the morbidity associated with pregnancy, delivery and the postpartum period is essential in understanding the burden of diseases due to maternal causes. The WHO estimates that up to 300 million women suffer from short- or long-term illnesses related to pregnancy and childbirth (WHO, 1998). In addition, the WHO estimates that in developing countries, death and disability related to maternal morbidity account for 18.5% of the burden of disease among women of reproductive age (WHO, 1998).
In Bangladesh, recent studies have suggested that a large proportion of women giving birth in rural areas experience pregnancy- and delivery- related complications (NIPORT et al, 2001), and more than 80% of the women suffer from a serious postpartum illness (Goodburn et al, 1994; BIRPERHT, 1994). In the baseline survey for the project "Community-Based Interventions to Reduce Neonatal Mortality in Bangladesh" in Sylhet, a total of 75% of women reported at least one maternal complication during pregnancy, delivery and the postpartum.
There is little evidence as to the effect of maternal care interventions on maternal morbidity. Several studies have evaluated the impact of traditional birth attendant (TBA) training on morbidity and referral rates. In a review of 15 studies on the effects of TBA training programs, Ray and Salihu found an improvement in maternal morbidities in two of the three studies reviewed, and an impact on referral rates in six of the seven studies reviewed (Ray & Salihu, 2004). In a meta-analysis conducted by Sibley et al, there was no effect detected between TBA training and recognition of maternal complications, referral for complications or on maternal compliance with referral (Sibley, Sipe, & Koblinsky, 2004).
Maternal morbidity is a substantial burden on the health of women in Bangladesh and throughout developing countries. Further research is needed to more carefully document the community-based incidence of maternal morbidity and to evaluate program impact on maternal morbidity.
The objectives of this study are to provide data on descriptive information on self-reported maternal morbidities for future planning, and to measure the effect of a package of maternal care interventions by comparing differences in care seeking for perceived complications and the unmet obstetric need (based on major obstetric interventions (MOI) for facility-validated absolute maternal indications (AMI) ) among the three arms, and by comparing anemia rates among the three arms.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Ecologic or Community
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Probability Sample|
|Study Population||Community sample|
|Intervention ICMJE||Behavioral: Care Seeking for Obstetric Complication
This is a descriptive study of knowledge, practices and outcomes related to maternal morbidity during pregnancy, childbirth and postpartum.
|Study Groups/Cohorts||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||May 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||Child, Adult, Senior|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Bangladesh|
|Removed Location Countries|
|NCT Number ICMJE||NCT00198731|
|Other Study ID Numbers ICMJE||H.22.04.09.03.D1|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Abdullah Baqui, JHSPH|
|Study Sponsor ICMJE||Johns Hopkins Bloomberg School of Public Health|
|Collaborators ICMJE||International Centre for Diarrhoeal Disease Research, Bangladesh|
|Information Provided By||Johns Hopkins Bloomberg School of Public Health|
|Verification Date||July 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP