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
| Verified date | July 2012 |
| Source | Hospital San Juan de Dios Guatemala |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Guatemala | Health Centers for vaginal deliveries (CAP) | Departamento de San Marcos |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital San Juan de Dios Guatemala | World Health Organization |
Guatemala,
| 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 |