NCT03151070: QVLM

Scaling Up an Integrated Approach to Improve Delivery Care in North Guatemala With Stepped Wedge Design

Completed Last updated 12 May 2017

What this trial tests

trial testing QVLM Intervention package in Maternal Sepsis During Labor in 32,000 participants. Completed in 15 March 2017.

Timeline

15 December 2013

Primary endpoint
15 March 2017

15 March 2017

Quick facts

Lead sponsor	Hospital San Juan de Dios Guatemala
Status	Completed
Study type	OBSERVATIONAL
Enrollment	32,000
Start date	15 December 2013
Primary completion	15 March 2017
Estimated completion	15 March 2017

Drugs / interventions tested

• QVLM Intervention package

Conditions studied

• Maternal Sepsis During Labor — all drugs for Maternal Sepsis During Labor →
• Hemorrhage, Postpartum — all drugs for Hemorrhage, Postpartum →
• Eclampsia; Complicating Pregnancy — all drugs for Eclampsia; Complicating Pregnancy →
• Pre-Eclampsia — all drugs for Pre-Eclampsia →

Sponsor

Hospital San Juan de Dios Guatemala

Who can join

Eligibility, any sex, with Maternal Sepsis During Labor or Hemorrhage, Postpartum. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

"¡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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Ethical issues in the design and conduct of stepped-wedge cluster randomized trials in low-resource settings.
   Joag K, Ambrosio G, Kestler E, Weijer C, et al · · 2019 · cited 14× · PMID 31852547 · DOI 10.1186/s13063-019-3842-1