Cluster-randomized Trial Measuring Integration of Professional Midwives and Obstetric Nurses in Rural Clinics in Mexico
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Purpose
Rates and causes of maternal mortality in Mexico have dropped only slightly; thus, reaching the internationally established Millennium Development Milestones (MDM) is still a distant goal. A fundamental part of reducing maternal and infant mortality is ensuring skilled attendance during pregnancy and delivery. This project uses an innovative strategy of integrating professional midwives and licensed obstetric nurses into rural medical centers in the states of Guerrero and Oaxaca, Mexico, to provide prenatal care, delivery services, and puerperium care. The goal of the research is to increase use of best practices in intake, labor, delivery, and puerperium care; decrease the use of unnecessary or harmful care; and improve maternal and neonatal outcomes. We posited that medical centers receiving the intervention would provide better care and have better maternal and neonatal outcomes than those that did not receive the intervention.
| Condition | Intervention |
|---|---|
|
Pregnancy |
Other: PM/ON integration |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Incorporation of Alternative Providers for Care During Pregnancy, Delivery and Postpartum in Rural Public Health Clinics. |
- Use of evidence-based practices during labor, delivery, and postpartum care [ Time Frame: 21 months ] [ Designated as safety issue: Yes ]Will collect data on deliveries ocurring in sites over 21 month period.
- volume of prenatal visits, deliveries [ Time Frame: 21 months ] [ Designated as safety issue: No ]We will Assess overall number of first and follow up prenatal visits and deliveries in intervention and control sites
- Use of harmful or unnecessary practices during labor and delivery [ Time Frame: 21 months ] [ Designated as safety issue: Yes ]We will assess use of harmful or unnecessary practices during labor and delivery
| Enrollment: | 27 |
| Study Start Date: | November 2007 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PM/ON integration arm
Health centers where professional midwives or obstetric nurses are integrated into clinic staff and delivering services.
|
Other: PM/ON integration
Professional midwives or obstetric nurses are integrated into clinic staff and delivering services.
|
| No Intervention: Control |
Eligibility| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinics containing one medical team only (1 doctor and accompanying staff)
- Clinics less than 2 hours away from a referral hospital
- Clinics where at least 25 deliveries took place in the previous year
Exclusion Criteria:
- Clinics inaccessible by car
- Clinics undergoing remodeling
Contacts and Locations| Principal Investigator: | Dilys Walker, MD | Instituto Nacional de Salud Publica, Mexico |
More Information
No publications provided
| Responsible Party: | Dilys Walker, Investidadora Asociada C, Instituto Nacional de Salud Publica, Mexico |
| ClinicalTrials.gov Identifier: | NCT01477541 History of Changes |
| Other Study ID Numbers: | 104-6466 |
| Study First Received: | November 18, 2011 |
| Last Updated: | November 18, 2011 |
| Health Authority: | Mexico: National Institute of Public Health, Health Secretariat Mexico: Ministry of Health |
Keywords provided by Instituto Nacional de Salud Publica, Mexico:
|
Prenatal care Maternal mortality Perinatal mortality Perinatal Puerperium Puerperium care Midwives Midwife Obstetric |
Nurse Integration Alternative personnel Skilled attendant Birth attendant Delivery Delivery services Best practices Rural |
ClinicalTrials.gov processed this record on May 22, 2013