CClinicalTrials.gg
CompletedNCT00198731Updated Apr 5, 2021

Evaluation of the Effects of Community-based Interventions

An observational study in Pregnancy, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 1 site in Bangladesh. Per ClinicalTrials.gov, last updated 2021-04-05.

Sponsored by Johns Hopkins Bloomberg School of Public Health · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
1,506
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Pregnancy

Keywords

  • maternal health
  • Bangladesh
  • care seeking
03

In context

Lead sponsor

Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 364 studies on the registry; 41 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Community sample

Inclusion criteria

  • Qualitative research:
  • Women who have given birth within six to twelve months in sthe study area who give consent to participate in the study
  • Quantitative research:
  • Women who have given birth in the past 4-8 weeks in the study area who give consent to participate in study
  • Women who have experienced a major obstetric intervention in the 12 months prior to the survey who give consent to participate in the study
  • Family members of women who have died due to a maternal cause in the 12 months prior to the survey who give consent to participate in the study
  • All women enrolled in the home care arm of the parent study who agree to have their temperature taken postpartum

Exclusion criteria

Exclusion Criteria:

  • there are no exclusion criteria
05

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
1,506 participants (actual)

Interventions

  • BehavioralCare Seeking for Obstetric Complication

    This is a descriptive study of knowledge, practices and outcomes related to maternal morbidity during pregnancy, childbirth and postpartum.

06

Study locations

1 site
  • N/A - community-based study
    Beanibazar, Zakigang And Kanaighat, Bangladesh
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00198731
Lead sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Responsible party
Sponsor
First posted
Sep 20, 2005
Start date
Apr 2005
Primary completion
May 2007
Completion
May 2007
Last update
Apr 5, 2021

Study contacts

Abdullah Baqui
principal investigator · Johns Hopkins Bloomberg School of Public Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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