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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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01653626
Enrollment
1
Registered
2012-07-31
Start date
2012-07-31
Completion date
2013-12-31
Last updated
2012-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

¨Maternal Morbidity¨, ¨Perinatal Mortality¨

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

Interventions

OTHERpackage of 3 interventions

Emergency Obstetric Care training, social marketing approach and link TBS with public sector services

Sponsors

World Health Organization
CollaboratorOTHER
Hospital San Juan de Dios Guatemala
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
10 Years to 49 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
increase the proportion of institutional deliveries in intervention vs. control clustersUp to 15 months

Secondary

MeasureTime frame
Decrease perinatal death rate in intervention vs. control clinicsUp to 15 months

Countries

Guatemala

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026