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Completed

NCT Number: NCT01865656

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

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.

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Key information

Conditions

Obstetric and Perinatal Complications Asphyxia Neonatorum Birth Asphyxia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eclampsia Female Urogenital Diseases and Pregnancy Complications Hemorrhage Hypertension, Pregnancy-Induced Infant, Newborn, Diseases Infections Inflammation Obstetric Labor Complications Obstructed/Prolonged Labor Pathologic Processes Pathological Conditions, Signs and Symptoms Postpartum Hemorrhage Pre-Eclampsia Preeclampsia/Eclampsia Pregnancy Complications Puerperal Disorders Sepsis Systemic Inflammatory Response Syndrome Urogenital Diseases Uterine Hemorrhage

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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:

  • 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.
  • 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.
  • Estimate the appropriateness and effectiveness of referrals in intervention facilities compared to controls.
  • Calculate the incremental cost and cost-effectiveness of the EmONC skills and drills intervention

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skills training

Other

Refresher training on Basic Emergency Obstetric and Newborn care

Emergency obstetric drills

Other

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

Revised Case Sheets

Other

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

Supportive supervision

Other

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

Referral strengthening

Other

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

Primary outcomes

  1. Appropriate management of direct obstetric and perinatal complications

    Time frame: Month 18 of the project

    Appropriate and timely management of postpartum hemorrhage (PPH), Preeclampsia, Obstructed or prolonged labor, Sepsis and birth asphyxia

Secondary outcomes

  1. Feasibility of the intervention

    Time frame: Month 18 of the project

    We will evaluate barriers and facilitators of implementing these intervention packages, as well as costing them.

  2. Acceptability of the intervention

    Time frame: Month 18 of the project

    Using in-depth interviews with providers, we will assess the acceptability of the interventions.

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

    Time frame: Month 18 of the project

    Providers will be assessed on self-efficacy pre and post intervention

  4. Knowledge and skills competency of health care personnel on the management of obstetric and neonatal complications

    Time frame: Month 18 of the project

  5. Case-fatality rates

    Time frame: Month 18 of the project

    Using data from obstetric and newborn case sheets we will assess case-fatality rates

  6. Timeliness and appropriateness of referral

    Time frame: Month 18 of the project

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • Karnataka Health Promotion Trust
  • Maternal Health Task Force
  • St. John's Research Institute

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
May 31, 2013
Registry last updated
Jan 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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