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| ID | Type | Description | Link |
|---|---|---|---|
| REF/2013/05/005058 | Registry Identifier | Clinical Trials Registry- India |
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| Name | Class |
|---|---|
| St. John's Research Institute | OTHER |
| Maternal Health Task Force | UNKNOWN |
| Bill and Melinda Gates Foundation | OTHER |
| Karnataka Health Promotion Trust |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Control Arm | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skills training | Other | Refresher training on Basic Emergency Obstetric and Newborn care |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the intervention | We will evaluate barriers and facilitators of implementing these intervention packages, as well as costing them. | Month 18 of the project |
| Acceptability of the intervention |
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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
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
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| OTHER |
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| Emergency obstetric drills | Other | Emergency obstetric drills to practice timely and appropriate management of postpartum hemorrhage and preeclampsia/eclampsia |
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| Revised Case Sheets | Other | Revised case sheets will be introduced to capture the timing and appropriate medical treatment of women in labor and newborns |
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| Supportive supervision | Other | Quarterly supportive supervision visits each of the intervention first referral units. |
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| Referral strengthening | Other | To support referral systems that ensure timely and appropriate treatment for obstetric emergencies |
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Using in-depth interviews with providers, we will assess the acceptability of the interventions.
| Month 18 of the project |
| Self-efficacy of health care personnel to manage direct obstetric and neonatal complications | Providers will be assessed on self-efficacy pre and post intervention | 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 | Using data from obstetric and newborn case sheets we will assess case-fatality rates | Month 18 of the project |
| Timeliness and appropriateness of referral | Month 18 of the project |
| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| D011225 | Pre-Eclampsia |
| D004461 | Eclampsia |
| D018805 | Sepsis |
| D001238 | Asphyxia Neonatorum |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D046110 | Hypertension, Pregnancy-Induced |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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