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

Maternal Morbidity¨ Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01653626
• Other study ID #: GUACTEK01
• Status: Unknown status
• Phase: N/A
• First received: July 25, 2012
• Last updated: July 30, 2012
• Start date: July 2012
• Est. completion date: December 2013

Study information

• Verified date: July 2012
• Source: Hospital San Juan de Dios Guatemala
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 1
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 10 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Maternal Morbidity¨
• Perinatal Death
• Perinatal Mortality¨

Intervention

Other:
• package of 3 interventions
Emergency Obstetric Care training, social marketing approach and link TBS with public sector services

Locations

Country	Name	City	State
Guatemala	Health Centers for vaginal deliveries (CAP)	Departamento de San Marcos

Sponsors (2)

Lead Sponsor	Collaborator
Hospital San Juan de Dios Guatemala	World Health Organization

Country where clinical trial is conducted

Guatemala, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	increase the proportion of institutional deliveries in intervention vs. control clusters		Up to 15 months
Secondary	Decrease perinatal death rate in intervention vs. control clinics		Up to 15 months