Maternal Sepsis During LaborQVLMNCT03151070
Scaling Up an Integrated Approach to Improve Delivery Care in North Guatemala With Stepped Wedge Design
An observational study of Maternal Sepsis During Labor and Hemorrhage, Postpartum, run by Hospital San Juan de Dios Guatemala.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Maternal Sepsis During Labor, Hemorrhage, Postpartum, Eclampsia; Complicating Pregnancy
- What is being tested?
- QVLM Intervention package
- How many people
- 32,000 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2013to 15 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The total population projected for 2014 for the involved communities is approximately 1.4 million. Each community is associated to one low level public health center. Communities in Huehuetenango have an average population of 34,158, and those in Alta Verapaz have 61,237. In the 33 communities, 75% of live births occurred at home while only 22% of live births had medical attention according to national live birth data from 2014. Huehuetenango district has perinatal mortality rate of 43 (per 100,000 live births) and Alta Verapaz district has 35. These two districts have the worst perinatal mortality indicators according to the guatemalan national survey on maternal and child health (ENSMI) for the period 2014-2015.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Scaling Up an Integrated Approach to Improve Delivery Care and Reduce Maternal and Perinatal Mortality in North Guatemala With Stepped Wedge Design
"¡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).
Read the 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.
- Conditions
- Maternal Sepsis During Labor, Hemorrhage, Postpartum, Eclampsia; Complicating Pregnancy, Pre-Eclampsia, Perinatal Morbidity
- Being tested
- QVLM Intervention package
- Medical subject headings
- Postpartum Hemorrhage, Eclampsia, Pregnancy Complications, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QVLM Intervention packageOther
QVLM intervention package consists of 3 simultaneous interventions:
- Social marketing to promote insitutional deliveries.
- PRONTO training to public health personnel
- Improve interaction with traditional birth attendants
| Study group | Role | What they receive |
|---|---|---|
| Zone 1 | Zone 1 includes the following communities from Huehuentenango Distric:
* San Rafael Petzal
* San Sebastian Huehuetenango
* San Gaspar Ixchil
* Santa Bárbara
* Colotenango
* Aguacatán Receives: Other: QVLM Intervention package | |
| Zone 2 | Zone 2 includes the following communities from Alta Verapaz district:
* Tamahú
* San Miguel Tucurú
* Panzós
* Senahú
* Telemán Receives: Other: QVLM Intervention package | |
| Zone 3 | Zone 3 includes the following communities from Huehuetenango district:
* San Idelfonso Ixtahuacán
* La Democracia
* San Juan Atitán
* Tectitán
* Santiago Chimaltenango Receives: Other: QVLM Intervention package | |
| Zona 4 | Zone 4 includes the following communities from Alta Verapaz district:
* Lanquín
* Santa María Cahabón
* Chisec
* Chahal
* Raxruhá
* Campur Receives: Other: QVLM Intervention package | |
| Zona 5 | Zone 5 includes the following communities from Huehuetenango district:
* Nenton
* Jacaltenango
* Todos Santos Cuchumatán
* Santa Eulalia
* San Mateo Ixtatán
* San Juan Ixcoy Receives: Other: QVLM Intervention package | |
| Zona 6 | Zone 6 includes the following communities from Alta Verapaz district:
* Santa Cruz Verapaz
* Tactic
* San Pedro Carchá
* San Juan Chamelco Receives: Other: QVLM Intervention package |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mother morbidity
Presence of any of the following conditions: post-partum hemorrhage, eclampsia, pre-eclampsia and sepsis.
Measured: January 2014 - January 2017
Perinatal morbidity
APGAR 1 and 5 minutes after birth. Special attention after birth (resucitation, AMBU and cardiac massage)
Measured: January 2014 - January 2017
Perinatal mortality
Death of the newborn during attention in the health center.
Measured: January 2014 - January 2017
Counts of institutional deliveries
Monthly counts of institutional deliveries in each health center.
Measured: January 2014 - January 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start15 Dec 2013
- Primary completion15 Mar 2017
- Study completion15 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Maternal Sepsis During LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 32,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital San Juan de Dios Guatemala
- Sponsor type
- Other government
- Collaborators
- Grand Challenges Canada, PRONTO International
- Responsible party
- Principal investigator, Edgar Kestler, Hospital San Juan de Dios Guatemala
- Investigators
- Edgar Kestler, Msc, Study director, Researh Center Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151070
- Sponsor's protocol ID
- CIESARQVLM17
- Acronym
- QVLM
- Status last verified
- May 2017
- First submitted
- 9 May 2017
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23517050Walker 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.
PubMed 26206373Hemming 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.
PubMed 25346484
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scaling Up an Integrated Approach to Improve Delivery Care and Reduce Maternal and Perinatal Mortality in North Guatemala With Stepped Wedge Design
- ClinicalTrials.gov ID
- NCT03151070
- Acronym / sponsor ID
- QVLM / CIESARQVLM17
- Conditions
- Maternal Sepsis During Labor, Hemorrhage, Postpartum, Eclampsia; Complicating Pregnancy, Pre-Eclampsia, Perinatal Morbidity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32,000 participants (actual)
- Lead sponsor
- Hospital San Juan de Dios GuatemalaOther government
- Collaborators
- Grand Challenges Canada, PRONTO International
- Study start
- 15 Dec 2013 (actual)
- Primary completion
- 15 Mar 2017 (actual)
- Study completion
- 15 Mar 2017 (actual)
- First posted
- 12 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"¡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).
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Zone 1 | – | Other: QVLM Intervention packageZone 1 includes the following communities from Huehuentenango Distric: * San Rafael Petzal * San Sebastian Huehuetenango * San Gaspar Ixchil * Santa Bárbara * Colotenango * Aguacatán |
| Zone 2 | – | Other: QVLM Intervention packageZone 2 includes the following communities from Alta Verapaz district: * Tamahú * San Miguel Tucurú * Panzós * Senahú * Telemán |
| Zone 3 | – | Other: QVLM Intervention packageZone 3 includes the following communities from Huehuetenango district: * San Idelfonso Ixtahuacán * La Democracia * San Juan Atitán * Tectitán * Santiago Chimaltenango |
| Zona 4 | – | Other: QVLM Intervention packageZone 4 includes the following communities from Alta Verapaz district: * Lanquín * Santa María Cahabón * Chisec * Chahal * Raxruhá * Campur |
| Zona 5 | – | Other: QVLM Intervention packageZone 5 includes the following communities from Huehuetenango district: * Nenton * Jacaltenango * Todos Santos Cuchumatán * Santa Eulalia * San Mateo Ixtatán * San Juan Ixcoy |
| Zona 6 | – | Other: QVLM Intervention packageZone 6 includes the following communities from Alta Verapaz district: * Santa Cruz Verapaz * Tactic * San Pedro Carchá * San Juan Chamelco |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The total population projected for 2014 for the involved communities is approximately 1.4 million. Each community is associated to one low level public health center. Communities in Huehuetenango have an average population of 34,158, and those in Alta Verapaz have 61,237. In the 33 communities, 75% of live births occurred at home while only 22% of live births had medical attention according to national live birth data from 2014. Huehuetenango district has perinatal mortality rate of 43 (per 100,000 live births) and Alta Verapaz district has 35. These two districts have the worst perinatal mortality indicators according to the guatemalan national survey on maternal and child health (ENSMI) for the period 2014-2015.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QVLM Intervention packageQVLM intervention package consists of 3 simultaneous interventions: * Social marketing to promote insitutional deliveries. * PRONTO training to public health personnel * Improve interaction with traditional birth attendants | Other | Zona 4, Zona 5, Zona 6, Zone 1, Zone 2, Zone 3 |
Primary outcome
Mother morbidity
Time frame: January 2014 - January 2017
Presence of any of the following conditions: post-partum hemorrhage, eclampsia, pre-eclampsia and sepsis.
Perinatal morbidity
Time frame: January 2014 - January 2017
APGAR 1 and 5 minutes after birth. Special attention after birth (resucitation, AMBU and cardiac massage)
Perinatal mortality
Time frame: January 2014 - January 2017
Death of the newborn during attention in the health center.
Counts of institutional deliveries
Time frame: January 2014 - January 2017
Monthly counts of institutional deliveries in each health center.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- Background: PubMed 23517050Kestler 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.
- Background: PubMed 26206373Walker 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.
- Background: PubMed 25346484Hemming 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edgar Kestler, Msc study director
Researh Center Director
Questions about this trial
What is this clinical trial studying?
An observational study of Maternal Sepsis During Labor and Hemorrhage, Postpartum, run by Hospital San Juan de Dios Guatemala.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mother morbidity (time frame: January 2014 - January 2017). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03151070, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2017.