- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03151070
Scaling Up an Integrated Approach to Improve Delivery Care in North Guatemala With Stepped Wedge Design (QVLM)
Scaling Up an Integrated Approach to Improve Delivery Care and Reduce Maternal and Perinatal Mortality in North Guatemala With Stepped Wedge Design
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Individual delivery data has been collected in site from health centers records. Thus, the study does not depend on official data from the ministry of health. Not only is MOH data hard to obtain, it also may not contain the details we are interested in that are put by hand by doctors and nurses in clinic histories. In order to get uniform data that fits the study needs, a parallel monitoring process has been set up. Data for mortality and morbidity events that occured in communities during the study is limited. We don't have the community counterpart of our indicators. Government data of perinatal deaths in community may be obtained with 1 or 2 years of delay, however there may be an underreporting of such events. Likewise, there is no data source for maternal morbidity in community deliveries since community practice is usually not documented nor reported.
The concept of perinatal mortality used in this study is not the standard concept that includes death from 28th gestational week to 7 days after birth. The perinatal mortality outcome in this study takes into account only deaths that occur during care in health centers (approximately 48 hours since birth). This is intentional since the aim of this study is to improve clinics' skilled delivery care, thereferore it is concerned on reducing the newborn deaths that occur during care given in site. Along this study, the focus is in these subset of perinatal deaths.
The APGAR measure 1 minute and 5 minutes after birth, and the reported procedures for the newborn are used to identify cases of perinatal morbidity.
This study is targetted to the low level health centers in Huehuetenango and Alta Verapaz. This includes 33 health centers. This is a fixed number of health centers and there is no control of the patients that got treated at the health centers. This is the reason why there is no sample size assessment. The selection of the health centers was limited by the definition of CAP (second level health facilities according to local definition) and the amount of patients that received the intervention by attending their deliveries in health centers can not be controlled.
Having data on all vaginal and uncomplicated deliveries that occur in health centers, the analysis can be done by individual cases and also by aggregating data in time periods. Also, analysis methodology of trials with stepped wedge design has been developed in the last years. A generalized mixed model for a multilevel and longitudinal analysis is going to be used in order to account for different sources of variability within and between health centers and times. So far (April 2017) we have done preliminary analysis this way and are confortable with this methodology selection.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- For participating facilities, health centers in Huehuetenango and Alta Verapaz districts.
- For participating facilities, health centers of type "CAP" (centro de atención permanente) which is the second level of attention in Guatemala, after attention in home and community.
- For institutional deliveries events, vaginal deliveries attended in participating health centers.
- For perinatal morbidity and mortality, any child that is born from an eligible vaginal delivery.
Exclusion Criteria:
- For deliveries, cesarean sections are ignored, since the training is focused on vaginal delivery care.
- In a secondary analysis, perinatal mortality cases that occured before arrival to the health center are excluded.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Zone 1
Zone 1 includes the following communities from Huehuentenango Distric:
|
QVLM intervention package consists of 3 simultaneous interventions:
|
Zone 2
Zone 2 includes the following communities from Alta Verapaz district:
|
QVLM intervention package consists of 3 simultaneous interventions:
|
Zone 3
Zone 3 includes the following communities from Huehuetenango district:
|
QVLM intervention package consists of 3 simultaneous interventions:
|
Zona 4
Zone 4 includes the following communities from Alta Verapaz district:
|
QVLM intervention package consists of 3 simultaneous interventions:
|
Zona 5
Zone 5 includes the following communities from Huehuetenango district:
|
QVLM intervention package consists of 3 simultaneous interventions:
|
Zona 6
Zone 6 includes the following communities from Alta Verapaz district:
|
QVLM intervention package consists of 3 simultaneous interventions:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mother morbidity
Time Frame: January 2014 - January 2017
|
Presence of any of the following conditions: post-partum hemorrhage, eclampsia, pre-eclampsia and sepsis.
|
January 2014 - January 2017
|
Perinatal morbidity
Time Frame: January 2014 - January 2017
|
APGAR 1 and 5 minutes after birth.
Special attention after birth (resucitation, AMBU and cardiac massage)
|
January 2014 - January 2017
|
Perinatal mortality
Time Frame: January 2014 - January 2017
|
Death of the newborn during attention in the health center.
|
January 2014 - January 2017
|
Counts of institutional deliveries
Time Frame: January 2014 - January 2017
|
Monthly counts of institutional deliveries in each health center.
|
January 2014 - January 2017
|
Collaborators and Investigators
Investigators
- Study Director: Edgar Kestler, Msc, Researh Center Director
Publications and helpful links
General Publications
- 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.
- 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.
- Hemming K, Lilford R, Girling AJ. Stepped-wedge cluster randomised controlled trials: a generic framework including parallel and multiple-level designs. Stat Med. 2015 Jan 30;34(2):181-96. doi: 10.1002/sim.6325. Epub 2014 Oct 24.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIESARQVLM17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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