Brief Summary

"¡Que Vivan las Madres!: Venga a tener su parto al CAP" (QVLM) is a guatemalan quasi-experimental study that has been performed from January 2014 to January 2017 by the Epidemiological Research Center in Sexual and Reproductive Health (CIESAR) in Guatemala in coordination with PRONTO International and University of San Francisco, California. This project has been financed by Grands Challenges Canada' "Save Lives at Birth, A Grand Challenge for Development" partnership that includes USAID, Norwegian ministry of foreign affairs, Bill\&Melinda Gates foundation, UKaid. This project has applied a stepped wedge design (SWD) over 6 zones or clusters. Each one of the zones contains from 4 to 6 communities, each one with the presence of one second level health facility (known in Spanish as CAP, Centro de Atención Permanente). These health centers are the next level in attention after home, traditional and empirical attention. Communities around the selected health centers are mostly rural and have the worst maternal health indicators in the country. These health centers are expected to have enough equipment and personnel to attend the deliveries that occur in their communities. This study was performed in Huehuetenango and Alta Verapaz districts in north Guatemala. Each one with 3 zones for a total of 6 zones. The study follows a Stepped Wedge Design, in which all 6 zones are eventually intervened, but at different regular periods of time (each period is 4 months long). This project applies a package of 3 simultaneous interventions in each zone with the purpose of increasing institutional deliveries and improving deliveries attention in public health centers. This intervention plan has been implemented in a pilot study reported in (Kestler et. al, 2013).

Trial Health

100

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

32,000

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Dec 2013

Typical duration for all trials

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.2 years study duration

Study Start

First participant enrolled

December 15, 2013

Completed

3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2017

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2017

Completed

3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2017

Completed

Last Updated

May 12, 2017

Status Verified

May 1, 2017

Enrollment Period

3.2 years

First QC Date

May 9, 2017

Last Update Submit

May 10, 2017

Conditions

Maternal Sepsis During Labor Hemorrhage, Postpartum Eclampsia; Complicating Pregnancy Pre-Eclampsia Perinatal Morbidity

Outcome Measures

Primary Outcomes (4)

Mother morbidity
Presence of any of the following conditions: post-partum hemorrhage, eclampsia, pre-eclampsia and sepsis.
January 2014 - January 2017
Perinatal morbidity
APGAR 1 and 5 minutes after birth. Special attention after birth (resucitation, AMBU and cardiac massage)
January 2014 - January 2017
Perinatal mortality
Death of the newborn during attention in the health center.
January 2014 - January 2017
Counts of institutional deliveries
Monthly counts of institutional deliveries in each health center.
January 2014 - January 2017

Study Arms (6)

Zone 1

Zone 1 includes the following communities from Huehuentenango Distric: * San Rafael Petzal * San Sebastian Huehuetenango * San Gaspar Ixchil * Santa Bárbara * Colotenango * Aguacatán