A Skills and Drills Intervention for Emergency Obstetrics and Neonatal Care at First Referral Units of North Karnataka
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|ClinicalTrials.gov Identifier: NCT01865656|
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : January 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Obstetric and Perinatal Complications Postpartum Hemorrhage Preeclampsia/Eclampsia Obstructed/Prolonged Labor Sepsis Birth Asphyxia||Other: Skills training Other: Emergency obstetric drills Other: Revised Case Sheets Other: Supportive supervision Other: Referral strengthening||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15018 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Skills and Drills Intervention for Improving Emergency Obstetric and Neonatal Care in Select First Referral Units in Northern Karnataka|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||January 2015|
4 intervention first referral units
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
Other: Skills training
Refresher training on Basic Emergency Obstetric and Newborn care
Other: Emergency obstetric drills
Emergency obstetric drills to practice timely and appropriate management of postpartum hemorrhage and preeclampsia/eclampsia
Other: Revised Case Sheets
Revised case sheets will be introduced to capture the timing and appropriate medical treatment of women in labor and newborns
Other: Supportive supervision
Quarterly supportive supervision visits each of the intervention first referral units.
Other: Referral strengthening
To support referral systems that ensure timely and appropriate treatment for obstetric emergencies
|No Intervention: Control Arm|
- 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
- Feasibility of the intervention [ Time Frame: Month 18 of the project ]We will evaluate barriers and facilitators of implementing these intervention packages, as well as costing them.
- Acceptability of the intervention [ Time Frame: Month 18 of the project ]Using in-depth interviews with providers, we will assess the acceptability of the interventions.
- Self-efficacy of health care personnel to manage direct obstetric and neonatal complications [ Time Frame: Month 18 of the project ]Providers will be assessed on self-efficacy pre and post intervention
- 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 ]Using data from obstetric and newborn case sheets we will assess case-fatality rates
- Timeliness and appropriateness of referral [ Time Frame: Month 18 of the project ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865656
|Principal Investigator:||Beena Verghese, PhD||St. John's Research Institute, Public Health Foundation of India|
|Principal Investigator:||Prem Mony, MD, MSc||St. John's Research Institute, Bangalore|
|Principal Investigator:||Krishnamurthy Jeyanna, MD||Karnataka Health Promotion Trust|
|Principal Investigator:||Ana Langer, MD||Harvard School of Public Health|
|Principal Investigator:||Fernando Althabe, MD||Institute for Clinical Effectiveness and Health Policy|