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A Study to Measure the Effectiveness of an Intervention Package Aiming to Decrease Perinatal Mortality and Increase Institution-based Obstetric Care Among Indigenous Populations in Guatemala

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ClinicalTrials.gov Identifier: NCT01653626
Recruitment Status : Unknown
Verified July 2012 by Edgar Kestler, World Health Organization.
Recruitment status was:  Recruiting
First Posted : July 31, 2012
Last Update Posted : July 31, 2012
Sponsor:
Collaborator:
World Health Organization
Information provided by (Responsible Party):
Edgar Kestler, World Health Organization

Tracking Information
First Submitted Date  ICMJE July 25, 2012
First Posted Date  ICMJE July 31, 2012
Last Update Posted Date July 31, 2012
Study Start Date  ICMJE July 2012
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2012)
increase the proportion of institutional deliveries in intervention vs. control clusters [ Time Frame: Up to 15 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2012)
Decrease perinatal death rate in intervention vs. control clinics [ Time Frame: Up to 15 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Measure the Effectiveness of an Intervention Package Aiming to Decrease Perinatal Mortality and Increase Institution-based Obstetric Care Among Indigenous Populations in Guatemala
Official Title  ICMJE A Matched Pair Cluster-randomized Implementation Study to Measure the Effectiveness of an Intervention Package Aiming to Decrease Perinatal Mortality and Increase Institution-based Obstetric Care Among Indigenous Populations in Guatemala
Brief Summary

A matched pair cluster-randomized trial of this intervention package will be conducted in four rural and indigenous districts (Huehuetenango, Quiche, Alta Verapaz and San Marcos) of the Republic of Guatemala, using the health clinic as the unit of randomization. No external intervention is planned for control facilities, although enhanced monitoring, surveillance and data collection will occur throughout the study in all facilities in the four districts.

The package includes 3 interventions: 1) To train health care professionals in emergency obstetric and perinatal care using an innovative high-fidelity, low-tech, in situ, multidisciplinary simulation training curriculum (PRONTO); 2) To design and implement a social marketing strategy that promotes institution-based delivery; and 3) To integrate the role of obstetric nurse and professional midwife in intervention communities to act as liaisons between traditional birth attendants (TBA) and public health units. A fourth, cross-cutting component involves ongoing analysis, monitoring, surveillance and evaluation to strengthen information systems and monitor perinatal outcomes throughout the two years of the study.

Detailed Description

Overall goal

To evaluate the impact of a package of three interventions aiming to increase institution-based delivery and improve emergency obstetric and neonatal care on perinatal mortality, in the four districts with the highest maternal mortality ratios in Guatemala.

Specific objectives

  • Measure the impact of this intervention package on perinatal mortality rates.
  • Measure the impact of this intervention package on the proportion of institution-based delivery among study facilities.
  • Evaluate the processes and success of implementing this combined package of interventions by analyzing process indicators related to the intervention element designed to improve emergency obstetric and neonatal care (PRONTO: emergency obstetric and perinatal training program).

Primary outcome of interest:

  1. Increase in the proportion of institutional deliveries in intervention vs. control clusters.
  2. Decrease perinatal death rate in intervention vrs control clinics
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • ¨Maternal Morbidity¨
  • ¨Perinatal Mortality¨
Intervention  ICMJE Other: package of 3 interventions
Emergency Obstetric Care training, social marketing approach and link TBS with public sector services
Study Arms  ICMJE Experimental: package
Intervention: Other: package of 3 interventions
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 30, 2012)
1
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2013
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • rural women
  • indigenous
  • poor
  • Facilities at rural area
  • Clinic attending vaginal deliveries

Exclusion Criteria:

  • Facilities considered too close geographically to risk contamination of intervention to control facilities
  • Clinics visits by pregnant women who present to intervention or control clinics for reasons other that an obstetric event
  • Clinic or hospital visits by women who present to intervention or control clinics in the post partum period
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 10 Years to 49 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Guatemala
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01653626
Other Study ID Numbers  ICMJE GUACTEK01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Edgar Kestler, World Health Organization
Study Sponsor  ICMJE Hospital San Juan de Dios Guatemala
Collaborators  ICMJE World Health Organization
Investigators  ICMJE
Principal Investigator: Edgar E Kestler, MD CIESAR
Principal Investigator: Edgar E. Kestler, MD CIESAR
PRS Account Hospital San Juan de Dios Guatemala
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP