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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
St. John's Research Institute
Maternal Health Task Force
Bill and Melinda Gates Foundation
Karnataka Health Promotion Trust
Information provided by (Responsible Party):
Ana Langer, Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT01865656
First received: May 28, 2013
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Skills and Drills Intervention for Improving Emergency Obstetric and Neonatal Care in Select First Referral Units in Northern Karnataka

Resource links provided by NLM:


Further study details as provided by Harvard School of Public Health:

Primary Outcome Measures:
  • Appropriate management of direct obstetric and perinatal complications [ Time Frame: Month 18 of the project ] [ Designated as safety issue: No ]
    Appropriate and timely management of postpartum hemorrhage (PPH), Preeclampsia, Obstructed or prolonged labor, Sepsis and birth asphyxia


Secondary Outcome Measures:
  • Feasibility of the intervention [ Time Frame: Month 18 of the project ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Case-fatality rates [ Time Frame: Month 18 of the project ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 7883
Study Start Date: July 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01865656

Sponsors and Collaborators
Harvard School of Public Health
St. John's Research Institute
Maternal Health Task Force
Bill and Melinda Gates Foundation
Karnataka Health Promotion Trust
Investigators
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
  More Information

No publications provided

Responsible Party: Ana Langer, Director of the Women and Health Initiative, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT01865656     History of Changes
Other Study ID Numbers: MHTF IR India, REF/2013/05/005058
Study First Received: May 28, 2013
Last Updated: December 16, 2013
Health Authority: India: Institutional Review Board
United States: Institutional Review Board

Keywords provided by Harvard School of Public Health:
provider skill and self-efficacy
Appropriate and timely referral for obstetric emergencies
Intervention feasibility and acceptability

Additional relevant MeSH terms:
Asphyxia Neonatorum
Emergencies
Hemorrhage
Postpartum Hemorrhage
Pre-Eclampsia
Disease Attributes
Hypertension, Pregnancy-Induced
Infant, Newborn, Diseases
Obstetric Labor Complications
Pathologic Processes
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage

ClinicalTrials.gov processed this record on October 22, 2014