NCT01192646

Brief Summary

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. 1.Can HBLSS increase women empowerment and male involvement in the decisions relating to access of emergency obstetric and newborn cares?
  2. 2.Can the HBLSS increase hospital deliveries, increase awareness of obstetric and neonatal danger signs, birth preparedness and emergency readiness in a rural community?
  3. 3.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.
  4. 4.To assess the impact of home based life saving skills (HBLSS) on hospital delivery awareness of obstetric and neonatal danger signs, birth preparedness
  5. 5.To explore customs, taboos and practices including herbal remedies during pregnancy and labour that influence birth preparedness and utilization of emergency obstetric care services.
  6. 6.To assess perception, attitude and health seeking behaviour when a complication occur.
  7. 7.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.
  8. 8.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.
  9. 9.To determine the cost-effectiveness of HBLSS educational programme

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable pregnancy

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2010

Completed
11 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

September 1, 2010

Status Verified

August 1, 2010

Enrollment Period

1 year

First QC Date

August 31, 2010

Last Update Submit

August 31, 2010

Conditions

Keywords

maternal healthbirth preparednesscost effectivenessmale involvementdelivery at hospitalcomplication readinessHealth seeking behavior in pregnancy, labour and pregnancy complication

Outcome Measures

Primary Outcomes (1)

  • Proportion of women delivering in a health facility

    1 year

Secondary Outcomes (5)

  • Proportion of community members pregnant mothers involved in birth preparedness and complication readiness

    1 year

  • Proportion of men involved in birth preparedness and assisting in women seeking care for complications.

    1 year

  • Proportion of pregnant women with birth plans

    1 year

  • Proportion of pregnant women using herbal remedies during pregnancy and labour

    1 year

  • The cost-effectiveness of HBLSS training

    1 year

Study Arms (2)

Home based life saving skills training

ACTIVE COMPARATOR

Home based life saving skills will done in one the study group and in the control group no training will be done

Behavioral: HBLSS

NO HBLSS

NO INTERVENTION

No intervention will be given to the control clusters

Behavioral: HBLSS

Interventions

HBLSSBEHAVIORAL

Home Based life saving skills training will be done in the intervention cluster while in the control group no training

Home based life saving skills trainingNO HBLSS

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rufiji District

Rufiji, Coast Region, 00000, Tanzania

Location

Related Publications (9)

  • Sibley L, Buffington ST, Beck D, Armbruster D. Home based life saving skills: promoting safe motherhood through innovative community-based interventions. J Midwifery Womens Health. 2001 Jul-Aug;46(4):258-66. doi: 10.1016/s1526-9523(01)00139-8.

    PMID: 11603641BACKGROUND
  • Mpembeni RN, Killewo JZ, Leshabari MT, Massawe SN, Jahn A, Mushi D, Mwakipa H. Use pattern of maternal health services and determinants of skilled care during delivery in Southern Tanzania: implications for achievement of MDG-5 targets. BMC Pregnancy Childbirth. 2007 Dec 6;7:29. doi: 10.1186/1471-2393-7-29.

    PMID: 18053268BACKGROUND
  • Ahluwalia I, Kouletio M, Curtis K, Schmid T. Observations from the CDC: community empowerment: CDC collaboration with the CARE Community-Based Reproductive Health Project in two districts in Tanzania. J Womens Health Gend Based Med. 1999 Oct;8(8):1015-9. doi: 10.1089/jwh.1.1999.8.1015. No abstract available.

    PMID: 10565658BACKGROUND
  • Ahluwalia IB, Schmid T, Kouletio M, Kanenda O. An evaluation of a community-based approach to safe motherhood in northwestern Tanzania. Int J Gynaecol Obstet. 2003 Aug;82(2):231-40. doi: 10.1016/s0020-7292(03)00081-x.

    PMID: 12873791BACKGROUND
  • Berer M. Maternal mortality and morbidity: is pregnancy getting safer for women? Reprod Health Matters. 2007 Nov;15(30):6-16. doi: 10.1016/S0968-8080(07)30338-8. No abstract available.

    PMID: 17938066BACKGROUND
  • Donner A and Klar N. Design and Analysis of Cluster Ramdomization Trial In Health Research. Arnold-Hooder Headline Group. 2000. ISBN 0 340 69153 0

    BACKGROUND
  • Goodburn E, Campbell O. Reducing maternal mortality in the developing world: sector-wide approaches may be the key. BMJ. 2001 Apr 14;322(7291):917-20. doi: 10.1136/bmj.322.7291.917. No abstract available.

    PMID: 11302911BACKGROUND
  • Graneheim UH, Lundman B. Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse Educ Today. 2004 Feb;24(2):105-12. doi: 10.1016/j.nedt.2003.10.001.

    PMID: 14769454BACKGROUND
  • National Bureau of Statistics (NBS) and ORC Macro. Tanzania Demographic and Health Survey 2004-5. Dar es salaam, Tanzania: National Bureau of statistics and ORC Macro. 2005

    BACKGROUND

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR
  • Siriel Massawe, MD, M.Med, M.Ed, PhD

    Muhimbili University of Health and Allied Sciences

    STUDY CHAIR
  • Elisabeth Darj, PhD

    Upssala University

    STUDY CHAIR

Central Study Contacts

Furaha August, MD, M.Med

CONTACT

Andrea Pembe, MD,M.Med, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2010

First Posted

September 1, 2010

Study Start

August 1, 2011

Primary Completion

August 1, 2012

Study Completion

December 1, 2012

Last Updated

September 1, 2010

Record last verified: 2010-08

Locations