Obstetric and Perinatal ComplicationsNCT01865656
A Skills and Drills Intervention for Emergency Obstetrics and Neonatal Care at First Referral Units of North Karnataka
A study testing Skills training, Emergency obstetric drills and Revised Case Sheets in people with Obstetric and Perinatal Complications and Postpartum Hemorrhage, run by Harvard School of Public Health (HSPH).
Trial summary
To evaluate the effectiveness of a First Referral Unit (FRU) Emergency Obstetric and Newborn Care (EmONC) skills and drills intervention, to estimate the appropriateness and effectiveness of referrals in intervention arm compared to control arm and to calculate the incremental cost and cost effectiveness of EmONC… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Obstetric and Perinatal Complications, Postpartum Hemorrhage, Preeclampsia/Eclampsia
- What is being tested?
- Skills training, Emergency obstetric drills and Revised Case Sheets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,018 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Jan 2015
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All women age who are referred or admitted directly to the first referral unit for a delivery or with a complication Staff working in the First Referral Units
Who cannot join
- no specific exclusion criteria
About this study
Official title: Skills and Drills Intervention for Improving Emergency Obstetric and Neonatal Care in Select First Referral Units in Northern Karnataka
To evaluate the effectiveness of a First Referral Unit (FRU) Emergency Obstetric and Newborn Care (EmONC) skills and drills intervention, to estimate the appropriateness and effectiveness of referrals in intervention arm compared to control arm and to calculate the incremental cost and cost effectiveness of EmONC skills and drills intervention.
Read the detailed description
The aim of this intervention is to improve the quality of care for institutional births with a special focus on improving the quality of Emergency Obstetric and Newborn Care (EmONC). This intervention will focus on improving the skills and practices of providers and through the improvement of referral networks, ensure timely and appropriate management of complications.
The specific objectives include:
- Evaluate the effectiveness of an FRU-level Basic and EmONC Skills and Drills intervention combined with the existing primary health centre (PHC) based nurse mentoring intervention in improving appropriate diagnosis and management of obstetric and perinatal complications.
- Assess the additional benefit of the EmONC Skills and drills intervention at FRUs in terms of improvement of obstetric and perinatal outcomes compared to the PHC-level intervention alone.
- Estimate the appropriateness and effectiveness of referrals in intervention facilities compared to controls.
- Calculate the incremental cost and cost-effectiveness of the EmONC skills and drills intervention
- Conditions
- Obstetric and Perinatal Complications, Postpartum Hemorrhage, Preeclampsia/Eclampsia, Obstructed/Prolonged Labor, Sepsis, Birth Asphyxia
- Being tested
- Skills training, Emergency obstetric drills, Revised Case Sheets, Supportive supervision, Referral strengthening
- Keywords
- provider skill and self-efficacy, Appropriate and timely referral for obstetric emergencies, Intervention feasibility and acceptability
- Medical subject headings
- Postpartum Hemorrhage, Pre-Eclampsia, Eclampsia, Sepsis, Asphyxia Neonatorum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skills trainingOther
Refresher training on Basic Emergency Obstetric and Newborn care
Emergency obstetric drillsOther
Emergency obstetric drills to practice timely and appropriate management of postpartum hemorrhage and preeclampsia/eclampsia
Revised Case SheetsOther
Revised case sheets will be introduced to capture the timing and appropriate medical treatment of women in labor and newborns
Supportive supervisionOther
Quarterly supportive supervision visits each of the intervention first referral units.
Referral strengtheningOther
To support referral systems that ensure timely and appropriate treatment for obstetric emergencies
| Study group | Role | What they receive |
|---|---|---|
| 4 intervention first referral units | Other | A Quasi-experimental intervention/control trial will be implemented to assess the impact of the following interventions on the outcome measures in a cluster of 4 intervention sites relative to a matched cluster of 4 control sites:
Refresher/simulation training to improve provider skills/knowledge Implementation of Emergency Obstetric Drills Revised Case sheets(for data collection and therefore part of both control and intervention sites), Mentoring and Supportive supervision, and Referral Strengthening Receives: Other: Skills training; Other: Emergency obstetric drills; Other: Revised Case Sheets; Other: Supportive supervision; Other: Referral strengthening |
| Control Arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appropriate management of direct obstetric and perinatal complications
Appropriate and timely management of postpartum hemorrhage (PPH), Preeclampsia, Obstructed or prolonged labor, Sepsis and birth asphyxia
Measured: Month 18 of the project
Secondary outcomes (6)
Feasibility of the intervention
We will evaluate barriers and facilitators of implementing these intervention packages, as well as costing them.
Measured: Month 18 of the project
Acceptability of the intervention
Using in-depth interviews with providers, we will assess the acceptability of the interventions.
Measured: Month 18 of the project
Self-efficacy of health care personnel to manage direct obstetric and neonatal complications
Providers will be assessed on self-efficacy pre and post intervention
Measured: Month 18 of the project
Knowledge and skills competency of health care personnel on the management of obstetric and neonatal complications
Measured: Month 18 of the project
Case-fatality rates
Using data from obstetric and newborn case sheets we will assess case-fatality rates
Measured: Month 18 of the project
Timeliness and appropriateness of referral
Measured: Month 18 of the project
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startJul 2013
- Primary completionOct 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric and Perinatal ComplicationsStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15,018 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- St. John's Research Institute, Maternal Health Task Force, Bill and Melinda Gates Foundation, Karnataka Health Promotion Trust
- Responsible party
- Principal investigator, Ana Langer, Harvard School of Public Health (HSPH)
- Investigators
- Beena Verghese, PhD, Principal investigator, St. John's Research Institute, Public Health Foundation of IndiaPrem Mony, MD, MSc, Principal investigator, St. John's Research Institute, BangaloreKrishnamurthy Jeyanna, MD, Principal investigator, Karnataka Health Promotion TrustAna Langer, MD, Principal investigator, Harvard School of Public Health (HSPH)Fernando Althabe, MD, Principal investigator, Institute for Clinical Effectiveness and Health Policy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865656
- Sponsor's protocol ID
- MHTF IR India
- Other IDs
- REF/2013/05/005058
- Status last verified
- Jan 2015
- First submitted
- 28 May 2013
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skills and Drills Intervention for Improving Emergency Obstetric and Neonatal Care in Select First Referral Units in Northern Karnataka
- ClinicalTrials.gov ID
- NCT01865656
- Acronym / sponsor ID
- MHTF IR India
- Conditions
- Obstetric and Perinatal Complications, Postpartum Hemorrhage, Preeclampsia/Eclampsia, Obstructed/Prolonged Labor, Sepsis, Birth Asphyxia
- Keywords
- provider skill and self-efficacy, Appropriate and timely referral for obstetric emergencies, Intervention feasibility and acceptability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15,018 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- St. John's Research Institute, Maternal Health Task Force, Bill and Melinda Gates Foundation, Karnataka Health Promotion Trust
- Study start
- Jul 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 31 May 2013 (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.
To evaluate the effectiveness of a First Referral Unit (FRU) Emergency Obstetric and Newborn Care (EmONC) skills and drills intervention, to estimate the appropriateness and effectiveness of referrals in intervention arm compared to control arm and to calculate the incremental cost and cost effectiveness of EmONC skills and drills intervention.
Detailed description
The aim of this intervention is to improve the quality of care for institutional births with a special focus on improving the quality of Emergency Obstetric and Newborn Care (EmONC). This intervention will focus on improving the skills and practices of providers and through the improvement of referral networks, ensure timely and appropriate management of complications.
The specific objectives include:
- Evaluate the effectiveness of an FRU-level Basic and EmONC Skills and Drills intervention combined with the existing primary health centre (PHC) based nurse mentoring intervention in improving appropriate diagnosis and management of obstetric and perinatal complications.
- Assess the additional benefit of the EmONC Skills and drills intervention at FRUs in terms of improvement of obstetric and perinatal outcomes compared to the PHC-level intervention alone.
- Estimate the appropriateness and effectiveness of referrals in intervention facilities compared to controls.
- Calculate the incremental cost and cost-effectiveness of the EmONC skills and drills intervention
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4 intervention first referral units | Other | Other: Skills training, Other: Emergency obstetric drills, Other: Revised Case Sheets, Other: Supportive supervision, Other: Referral strengtheningA Quasi-experimental intervention/control trial will be implemented to assess the impact of the following interventions on the outcome measures in a cluster of 4 intervention sites relative to a matched cluster of 4 control sites: Refresher/simulation training to improve provider skills/knowledge Implementation of Emergency Obstetric Drills Revised Case sheets(for data collection and therefore part of both control and intervention sites), Mentoring and Supportive supervision, and Referral Strengthening |
| Control Arm | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All women age who are referred or admitted directly to the first referral unit for a delivery or with a complication Staff working in the First Referral Units
Key exclusion criteria (1 listed)
- no specific exclusion criteria
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 |
|---|---|---|
| Skills trainingRefresher training on Basic Emergency Obstetric and Newborn care | Other | 4 intervention first referral units |
| Emergency obstetric drillsEmergency obstetric drills to practice timely and appropriate management of postpartum hemorrhage and preeclampsia/eclampsia | Other | 4 intervention first referral units |
| Revised Case SheetsRevised case sheets will be introduced to capture the timing and appropriate medical treatment of women in labor and newborns | Other | 4 intervention first referral units |
| Supportive supervisionQuarterly supportive supervision visits each of the intervention first referral units. | Other | 4 intervention first referral units |
| Referral strengtheningTo support referral systems that ensure timely and appropriate treatment for obstetric emergencies | Other | 4 intervention first referral units |
Primary outcome
Appropriate management of direct obstetric and perinatal complications
Time frame: Month 18 of the project
Appropriate and timely management of postpartum hemorrhage (PPH), Preeclampsia, Obstructed or prolonged labor, Sepsis and birth asphyxia
6 secondary outcomes
Feasibility of the intervention
Time frame: Month 18 of the project
Acceptability of the intervention
Time frame: Month 18 of the project
Self-efficacy of health care personnel to manage direct obstetric and neonatal complications
Time frame: Month 18 of the project
Knowledge and skills competency of health care personnel on the management of obstetric and neonatal complications
Time frame: Month 18 of the project
Case-fatality rates
Time frame: Month 18 of the project
Timeliness and appropriateness of referral
Time frame: Month 18 of the project
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 28 Jan 2015.
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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.
Beena Verghese, PhD principal investigator
St. John's Research Institute, Public Health Foundation of India
Prem Mony, MD, MSc principal investigator
St. John's Research Institute, Bangalore
Krishnamurthy Jeyanna, MD principal investigator
Karnataka Health Promotion Trust
Questions about this trial
What is this clinical trial studying?
A study testing Skills training, Emergency obstetric drills and Revised Case Sheets in people with Obstetric and Perinatal Complications and Postpartum Hemorrhage, run by Harvard School of Public Health (HSPH).
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 1 inclusion and 1 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 28 Jan 2015. 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?
Appropriate management of direct obstetric and perinatal complications (time frame: Month 18 of the project). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2015.