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Home Based Life Saving Skills Training in a Rural Area in Tanzania (HBLSS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Muhimbili University of Health and Allied Sciences.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Uppsala University
Swedish International Development Cooperation Agency (SIDA)
Information provided by:
Muhimbili University of Health and Allied Sciences
ClinicalTrials.gov Identifier:
NCT01192646
First received: August 31, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

Background

The maternal mortality ratio in Tanzania has been persistently high for ten years with no signs of the ratio going down.The Tanzania Demographic and Health Survey (TDHS) of 1999 and 2005 estimate the maternal mortality ratio to be 528 and 578 per 100,000 live births respectively (TDHS 1999, TDHS 2004/05).The major direct causes include obstetric haemorrhage, obstructed labour, pregnancy induced hypertension, sepsis and abortion complications.

Most deliveries (53%) in Tanzania occur outside the health facilities. Of these 53% of births that occur outside the health facilities 31% are attended by relatives, 19% by traditional births attendants (TBA) while 3% have no assistance at all. Though, the proportional of mothers delivering in health facilities (47%) and receiving skilled attendance at birth (46%) is low but more than 94 percent of women attend antenatal care (ANC) in health facilities at least once. This indicates that there are factors that impede these women delivering in the health facilities.

Low awareness of obstetric danger signs may be one of the contributing factors for delay to decide to seek care when a complication occur thus contributing the first phase of delay. Studies in Tanzania show that most women are not aware of danger signs of obstetric complications during pregnancy, delivery and after delivery. A study conducted in Mtwara rural to assess the use and determinants of skilled attendants at delivery showed that proportional of women delivered with skilled care increases with increasing knowledge of pregnancy danger signs, but it also showed that few women have knowledge of pregnancy danger signs

An increasing body of evidence supports the importance of community participation in maternal and infant health programs for establishing ownership, identifying problems effectively, achieving equity and helping to institutionalize health programs. To mount an effective maternal health effort aimed at reducing maternal and infant mortality, multiple levels of program and policies need to be in place and functioning. In addition, linkages, from the communities, local dispensaries and health centres to first referral hospitals that are adequately equipped, need to be developed and sustained

A home based life saving skills (HBLSS) is a strategy that intends to educate pregnant women and their primary family caregivers and home birth attendants on critical knowledge and skills to keep a pregnant woman healthy, to recognize life-threatening maternal and newborn complications and promote the adoption of health care and health-seeking behaviours at the individual and community levels. The aim of this strategy is to prevent maternal and neonatal morbidity and mortality through creating awareness on women's birth preparedness and access to emergency obstetric care services

RESEARCH QUESTIONS

  1. Can HBLSS increase women empowerment and male involvement in the decisions relating to access of emergency obstetric and newborn cares?
  2. Can the HBLSS increase hospital deliveries, increase awareness of obstetric and neonatal danger signs, birth preparedness and emergency readiness in a rural community?

Objectives

Broad Objectives:

  1. To investigate social-cultural, community and traditional practices that impact on women's birth preparedness and access and utilization of emergency obstetric care services in rural district.
  2. To assess the impact of home based life saving skills (HBLSS) on hospital delivery awareness of obstetric and neonatal danger signs, birth preparedness

Specific Objectives

  1. To explore customs, taboos and practices including herbal remedies during pregnancy and labour that influence birth preparedness and utilization of emergency obstetric care services.
  2. To assess perception, attitude and health seeking behaviour when a complication occur.
  3. To determine the effect of HBLSS educational programme on hospital delivery, birth preparedness, emergency readiness and utilization of emergency obstetric care services among women in Rufiji district.
  4. To assess the impact of HBLSS educational programme on male awareness and involvement in assisting women on birth preparedness and access to emergency obstetric care services.
  5. To determine the cost-effectiveness of HBLSS educational programme

Methodology

A Cluster Randomized Trial

28 clusters will be randomly selected, 14 clusters will receive HBLSS training and the other 14 clusters will not receive HBLSS training.


Condition Intervention
Pregnancy
Behavioral: HBLSS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: IMPACT OF HOME BASED LIFE SAVING SKILLS TRAINING IN A RURAL AREA IN TANZANIA IN FACILITY DELIVERY, PREPARATION OF BIRTH PLANS AND COST-EFFECTIVENESS. AN INTERVENTION CLUSTER RANDOMIZED TRIAL.

Resource links provided by NLM:


Further study details as provided by Muhimbili University of Health and Allied Sciences:

Primary Outcome Measures:
  • Proportion of women delivering in a health facility [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of community members pregnant mothers involved in birth preparedness and complication readiness [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Proportion of men involved in birth preparedness and assisting in women seeking care for complications. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Proportion of pregnant women with birth plans [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Proportion of pregnant women using herbal remedies during pregnancy and labour [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The cost-effectiveness of HBLSS training [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 28
Study Start Date: August 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Home based life saving skills training
Home based life saving skills will done in one the study group and in the control group no training will be done
Behavioral: HBLSS
Home Based life saving skills training will be done in the intervention cluster while in the control group no training
No Intervention: NO HBLSS
No intervention will be given to the control clusters
Behavioral: HBLSS
Home Based life saving skills training will be done in the intervention cluster while in the control group no training

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women in the community
  • Relatives of the pregnant women including aunts, husbands and in-laws

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01192646

Contacts
Contact: Furaha August, MD, M.Med 255754304250 drfuraha@gmail.com
Contact: Andrea Pembe, MD,M.Med, PhD 255754262483 drfuraha@gmail.com

Locations
Tanzania
Rufiji District Not yet recruiting
Rufiji, Pwani Region, Tanzania, 00000
Sponsors and Collaborators
Muhimbili University of Health and Allied Sciences
Uppsala University
Swedish International Development Cooperation Agency (SIDA)
Investigators
Principal Investigator: Furaha August, MD,M.Med Muhimbili University of Health and Allied Sciences
Principal Investigator: Andrea Pembe, MD, M.Med, PhD Muhimbili University of Health and Allied Sciences
Study Chair: Siriel Massawe, MD, M.Med, M.Ed, PhD Muhimbili University of Health and Allied Sciences
Study Chair: Elisabeth Darj, PhD Upssala University
  More Information

Publications:
Responsible Party: Dr Furaha August, Muhimbili University of Health and Allied Sciences
ClinicalTrials.gov Identifier: NCT01192646     History of Changes
Other Study ID Numbers: HBLSS TRIAL
Study First Received: August 31, 2010
Last Updated: August 31, 2010
Health Authority: Tanzania: National Institute for Medical Research

Keywords provided by Muhimbili University of Health and Allied Sciences:
maternal health
birth preparedness
cost effectiveness
male involvement
delivery at hospital
complication readiness
Health seeking behavior in pregnancy, labour and pregnancy complication

ClinicalTrials.gov processed this record on November 25, 2014