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

Not Applicable

Completed

• Conditions: Birth Asphyxia; Preeclampsia/Eclampsia; Sepsis; Obstetric and Perinatal Complications; Postpartum Hemorrhage; Obstructed/Prolonged Labor

• Registration Number: NCT01865656
• Lead Sponsor: Harvard School of Public Health (HSPH)

Brief 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.

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:

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

Study Timeline

• Study First Submitted: 2013-05-28
• Study First Submitted QC: 2013-05-30
• Study First Posted: 2013-05-31
• Study Start: 2013-07
• Primary Completion: 2014-10
• Status Verified: 2015-01
• Study Completion: 2015-01
• Last Update Submitted: 2015-01-26
• Last Update Posted: 2015-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15018

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Appropriate management of direct obstetric and perinatal complications	Month 18 of the project	Appropriate and timely management of postpartum hemorrhage (PPH), Preeclampsia, Obstructed or prolonged labor, Sepsis and birth asphyxia

Secondary Outcome Measures

Name	Time	Method
Acceptability of the intervention	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	Month 18 of the project	Providers will be assessed on self-efficacy pre and post intervention
Feasibility of the intervention	Month 18 of the project	We will evaluate barriers and facilitators of implementing these intervention packages, as well as costing them.
Timeliness and appropriateness of referral	Month 18 of the project
Knowledge and skills competency of health care personnel on the management of obstetric and neonatal complications	Month 18 of the project
Case-fatality rates	Month 18 of the project	Using data from obstetric and newborn case sheets we will assess case-fatality rates