A Skills and Drills Intervention for Emergency Obstetrics and Neonatal Care at First Referral Units of North Karnataka

Sepsis Clinical Trial

Official title:

Skills and Drills Intervention for Improving Emergency Obstetric and Neonatal Care in Select First Referral Units in Northern Karnataka

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01865656
• Other study ID #: MHTF IR India
• Secondary ID: REF/2013/05/0050
• Status: Completed
• Phase: N/A
• First received: May 28, 2013
• Last updated: January 26, 2015
• Start date: July 2013
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review BoardUnited States: Institutional Review Board
• Study type: Interventional

Clinical 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 skills and drills intervention.

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:

1. 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.

2. 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.

3. Estimate the appropriateness and effectiveness of referrals in intervention facilities compared to controls.

4. Calculate the incremental cost and cost-effectiveness of the EmONC skills and drills intervention

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15018
• Est. completion date: January 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

no specific exclusion criteria

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Asphyxia Neonatorum
• Birth Asphyxia
• Emergencies
• Obstetric and Perinatal Complications
• Obstructed/Prolonged Labor
• Postpartum Hemorrhage
• Preeclampsia/Eclampsia
• Sepsis

Intervention

Other:
• Skills training
Refresher training on Basic Emergency Obstetric and Newborn care
• Emergency obstetric drills
Emergency obstetric drills to practice timely and appropriate management of postpartum hemorrhage and preeclampsia/eclampsia
• Revised Case Sheets
Revised case sheets will be introduced to capture the timing and appropriate medical treatment of women in labor and newborns
• Supportive supervision
Quarterly supportive supervision visits each of the intervention first referral units.
• Referral strengthening
To support referral systems that ensure timely and appropriate treatment for obstetric emergencies

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Harvard School of Public Health	Bill and Melinda Gates Foundation, Karnataka Health Promotion Trust, Maternal Health Task Force, St. John's Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Month 18 of the project	No
Secondary	Feasibility of the intervention	We will evaluate barriers and facilitators of implementing these intervention packages, as well as costing them.	Month 18 of the project	No
Secondary	Acceptability of the intervention	Using in-depth interviews with providers, we will assess the acceptability of the interventions.	Month 18 of the project	No
Secondary	Self-efficacy of health care personnel to manage direct obstetric and neonatal complications	Providers will be assessed on self-efficacy pre and post intervention	Month 18 of the project	No
Secondary	Knowledge and skills competency of health care personnel on the management of obstetric and neonatal complications		Month 18 of the project	No
Secondary	Case-fatality rates	Using data from obstetric and newborn case sheets we will assess case-fatality rates	Month 18 of the project	No
Secondary	Timeliness and appropriateness of referral		Month 18 of the project	No