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PregnancyNCT00198731

Evaluation of the Effects of Community-based Interventions

An observational study of Pregnancy, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Pregnancy
What is being tested?
Care Seeking for Obstetric Complication
How many people
1,506 participants
Where
1 siteBangladesh
Study dates
Apr 2005to May 2007
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Community sample

Who may be able to join

  • 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

Who cannot join

  • there are no exclusion criteria

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site
  • N/A - community-based study

    Beanibazar, Zakigang and Kanaighat

Other trials in Bangladesh

About this study

Official title: Evaluation of the Effects of Community-based Interventions on Maternal Morbidity in the Early Postpartum Period in Rural Bangladesh

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.

Conditions
Pregnancy
Being tested
Care Seeking for Obstetric Complication
Keywords
maternal health, Bangladesh, care seeking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Care Seeking for Obstetric ComplicationBehavioural

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2005 (estimated)
  2. Study startApr 2005
  3. Primary completionMay 2007
  4. Study completionMay 2007

Resources

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
Ecologic or community
Time perspective
Prospective
Enrolment
1,506 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00198731
Sponsor's protocol ID
H.22.04.09.03.D1
Status last verified
Apr 2021
First submitted
12 Sep 2005
Last updated
5 Apr 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. 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 5 Apr 2021. 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 Bangladesh. 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.

Where can I read the original study information?
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 5 Apr 2021.

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