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| Name | Class |
|---|---|
| World Health Organization | OTHER |
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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.
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
Primary outcome of interest:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| package | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| package of 3 interventions | Other | Emergency Obstetric Care training, social marketing approach and link TBS with public sector services |
|
| Measure | Description | Time Frame |
|---|---|---|
| increase the proportion of institutional deliveries in intervention vs. control clusters | Up to 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease perinatal death rate in intervention vs. control clinics | Up to 15 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edgar E Kestler, MD | CIESAR | Principal Investigator |
| Edgar E. Kestler, MD | CIESAR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Centers for vaginal deliveries (CAP) | Recruiting | Departamento de San Marcos | Departamento de Guatemala | Guatemala |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26206373 | Derived | Walker DM, Holme F, Zelek ST, Olvera-Garcia M, Montoya-Rodriguez A, Fritz J, Fahey J, Lamadrid-Figueroa H, Cohen S, Kestler E. A process evaluation of PRONTO simulation training for obstetric and neonatal emergency response teams in Guatemala. BMC Med Educ. 2015 Jul 24;15:117. doi: 10.1186/s12909-015-0401-7. | |
| 23517050 | Derived |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 16, 2017 | |
| Reset | Oct 11, 2017 | |
| Release | Sep 18, 2019 |
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| Kestler E, Walker D, Bonvecchio A, de Tejada SS, Donner A. A matched pair cluster randomized implementation trail to measure the effectiveness of an intervention package aiming to decrease perinatal mortality and increase institution-based obstetric care among indigenous women in Guatemala: study protocol. BMC Pregnancy Childbirth. 2013 Mar 21;13:73. doi: 10.1186/1471-2393-13-73. |
| Reset | Oct 9, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 16, 2017 | Oct 11, 2017 | |||
| Sep 18, 2019 | Oct 9, 2019 |
| ID | Term |
|---|---|
| D066087 | Perinatal Death |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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