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

NCT01865656 | Completed

• 2 other identifiers: MHTF IR IndiaREF/2013/05/005058
• Study Type: interventional
• Target: 15,018
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Feasibility of the intervention

  Month 18 of the project

• Acceptability of the intervention

  Month 18 of the project

• Self-efficacy of health care personnel to manage direct obstetric and neonatal complications

  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

Study Arms (2)

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

Other: Skills training; Other: Emergency obstetric drills; Other: Revised Case Sheets; Other: Supportive supervision; Other: Referral strengthening

Control Arm

NO INTERVENTION

Interventions

Skills training OTHER

Refresher training on Basic Emergency Obstetric and Newborn care

4 intervention first referral units

Emergency obstetric drills OTHER

Emergency obstetric drills to practice timely and appropriate management of postpartum hemorrhage and preeclampsia/eclampsia

4 intervention first referral units

Revised Case Sheets OTHER

Revised case sheets will be introduced to capture the timing and appropriate medical treatment of women in labor and newborns

4 intervention first referral units

Supportive supervision OTHER

Quarterly supportive supervision visits each of the intervention first referral units.

4 intervention first referral units

Referral strengthening OTHER

To support referral systems that ensure timely and appropriate treatment for obstetric emergencies

4 intervention first referral units

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• St. John's Research Institute: collaborator
• Maternal Health Task Force: collaborator
• Bill and Melinda Gates Foundation: collaborator
• Karnataka Health Promotion Trust: collaborator

MeSH Terms

Conditions

Postpartum Hemorrhage; Pre-Eclampsia; Eclampsia; Sepsis; Asphyxia Neonatorum

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension, Pregnancy-Induced; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• 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 (HSPH)

  PRINCIPAL INVESTIGATOR

• Fernando Althabe, MD

  Institute for Clinical Effectiveness and Health Policy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Women and Health Initiative

Study Record Dates

• First Submitted: May 28, 2013
• First Posted: May 31, 2013
• Study Start: July 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: January 1, 2015
• Last Updated: January 28, 2015

Record last verified: 2015-01