¨Maternal Morbidity¨NCT01653626
A Study to Measure the Effectiveness of an Intervention Package Aiming to Decrease Perinatal Mortality and Increase Institution-based Obstetric Care Among Indigenous Populations in Guatemala
A study testing package of 3 interventions in people with ¨Maternal Morbidity¨ and ¨Perinatal Mortality¨, run by Hospital San Juan de Dios Guatemala at 1 site in Guatemala.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 49 years, women only
- Conditions the study is for
- ¨Maternal Morbidity¨, ¨Perinatal Mortality¨
- What is being tested?
- package of 3 interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteGuatemala
- Study dates
- Jul 2012to Dec 2013
- Phase
- Interventional
- 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 10 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- rural women
- indigenous
- poor
- Facilities at rural area
- Clinic attending vaginal deliveries
Who cannot join
- Facilities considered too close geographically to risk contamination of intervention to control facilities
- Clinics visits by pregnant women who present to intervention or control clinics for reasons other that an obstetric event
- Clinic or hospital visits by women who present to intervention or control clinics in the post partum period
Trial locations and contacts
1 site in 1 country.
Guatemala1 site, 1 recruiting
- Recruiting
Health Centers for vaginal deliveries (CAP)
Departamento de San Marcos, Departamento de Guatemala
Edgar E. Kestler, MD, (502) 22301494, ciesar@ciesar.org.gt
Dilys Walker, MD
About this study
Official title: A Matched Pair Cluster-randomized Implementation Study to Measure the Effectiveness of an Intervention Package Aiming to Decrease Perinatal Mortality and Increase Institution-based Obstetric Care Among Indigenous Populations in Guatemala
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.
Read the detailed description
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
- Measure the impact of this intervention package on perinatal mortality rates.
- Measure the impact of this intervention package on the proportion of institution-based delivery among study facilities.
- Evaluate the processes and success of implementing this combined package of interventions by analyzing process indicators related to the intervention element designed to improve emergency obstetric and neonatal care (PRONTO: emergency obstetric and perinatal training program).
Primary outcome of interest:
- Increase in the proportion of institutional deliveries in intervention vs. control clusters.
- Decrease perinatal death rate in intervention vrs control clinics
- Conditions
- ¨Maternal Morbidity¨, ¨Perinatal Mortality¨
- Being tested
- package of 3 interventions
- Medical subject headings
- Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
package of 3 interventionsOther
Emergency Obstetric Care training, social marketing approach and link TBS with public sector services
| Study group | Role | What they receive |
|---|---|---|
| package | Experimental | Not described Receives: Other: package of 3 interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
increase the proportion of institutional deliveries in intervention vs. control clusters
Measured: Up to 15 months
Secondary outcomes (1)
Decrease perinatal death rate in intervention vs. control clinics
Measured: Up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionOct 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ¨Maternal Morbidity¨Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital San Juan de Dios Guatemala
- Sponsor type
- Other government
- Collaborators
- World Health Organization
- Responsible party
- Principal investigator, Edgar Kestler, World Health Organization
- Investigators
- Edgar E Kestler, MD, Principal investigator, CIESAREdgar E. Kestler, MD, Principal investigator, CIESAR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653626
- Sponsor's protocol ID
- GUACTEK01
- Status last verified
- Jul 2012
- First submitted
- 25 Jul 2012
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26206373Kestler 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 23517050
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Matched Pair Cluster-randomized Implementation Study to Measure the Effectiveness of an Intervention Package Aiming to Decrease Perinatal Mortality and Increase Institution-based Obstetric Care Among Indigenous Populations in Guatemala
- ClinicalTrials.gov ID
- NCT01653626
- Acronym / sponsor ID
- GUACTEK01
- Conditions
- ¨Maternal Morbidity¨, ¨Perinatal Mortality¨
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Hospital San Juan de Dios GuatemalaOther government
- Collaborators
- World Health Organization
- Study start
- Jul 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 31 Jul 2012 (estimated)
- 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.
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.
Detailed description
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
- Measure the impact of this intervention package on perinatal mortality rates.
- Measure the impact of this intervention package on the proportion of institution-based delivery among study facilities.
- Evaluate the processes and success of implementing this combined package of interventions by analyzing process indicators related to the intervention element designed to improve emergency obstetric and neonatal care (PRONTO: emergency obstetric and perinatal training program).
Primary outcome of interest:
- Increase in the proportion of institutional deliveries in intervention vs. control clusters.
- Decrease perinatal death rate in intervention vrs control clinics
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| package | Experimental | Other: package of 3 interventions |
Who may qualify
- Ages
- 10 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- rural women
- indigenous
- poor
- Facilities at rural area
- Clinic attending vaginal deliveries
Key exclusion criteria (3 listed)
- Facilities considered too close geographically to risk contamination of intervention to control facilities
- Clinics visits by pregnant women who present to intervention or control clinics for reasons other that an obstetric event
- Clinic or hospital visits by women who present to intervention or control clinics in the post partum period
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 |
|---|---|---|
| package of 3 interventionsEmergency Obstetric Care training, social marketing approach and link TBS with public sector services | Other | package |
Primary outcome
increase the proportion of institutional deliveries in intervention vs. control clusters
Time frame: Up to 15 months
1 secondary outcome
Decrease perinatal death rate in intervention vs. control clinics
Time frame: Up to 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2012.
- Derived from this study: 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.
- Derived from this study: 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.
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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.
Health Centers for vaginal deliveries (CAP)
Departamento de San Marcos, Guatemala
Edgar E Kestler, MD principal investigator
CIESAR
Edgar E. Kestler, MD principal investigator
CIESAR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing package of 3 interventions in people with ¨Maternal Morbidity¨ and ¨Perinatal Mortality¨, run by Hospital San Juan de Dios Guatemala at 1 site in 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 31 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guatemala. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
increase the proportion of institutional deliveries in intervention vs. control clusters (time frame: Up to 15 months). 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 NCT01653626, which also lists 2 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 31 Jul 2012.