Clinical trial NCT01865656: A Skills and Drills Intervention for Emergency Obstetrics and Neonatal Care at First Referral Units of North Karnataka
Official title: Skills and Drills Intervention for Improving Emergency Obstetric and Neonatal Care in Select First Referral Units in Northern Karnataka
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: St. John's Research Institute
name: Maternal Health Task Force
name: Bill and Melinda Gates Foundation
name: Karnataka Health Promotion Trust
First posted: 2013-05-31
Enrollment: 15018
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Appropriate management of direct obstetric and perinatal complications
timeFrame: Month 18 of the project
Secondary outcomes:
measure: Feasibility of the intervention
timeFrame: Month 18 of the project
measure: Acceptability of the intervention
timeFrame: Month 18 of the project
measure: Self-efficacy of health care personnel to manage direct obstetric and neonatal complications
timeFrame: Month 18 of the project
measure: Knowledge and skills competency of health care personnel on the management of obstetric and neonatal complications
timeFrame: Month 18 of the project
measure: Case-fatality rates
timeFrame: Month 18 of the project
measure: Timeliness and appropriateness of referral
timeFrame: Month 18 of the project
Other outcomes:
Locations:
Study officials:
affiliation: St. John's Research Institute, Public Health Foundation of India
name: Beena Verghese, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. John's Research Institute, Bangalore
name: Prem Mony, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Karnataka Health Promotion Trust
name: Krishnamurthy Jeyanna, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard School of Public Health (HSPH)
name: Ana Langer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute for Clinical Effectiveness and Health Policy
name: Fernando Althabe, MD
role: PRINCIPAL_INVESTIGATOR
References: