Cluster-randomized Trial Measuring Integration of Professional Midwives and Obstetric Nurses in Rural Clinics in Mexico

Pregnancy Clinical Trial

Official title:

Incorporation of Alternative Providers for Care During Pregnancy, Delivery and Postpartum in Rural Public Health Clinics.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01477541
• Other study ID #: 104-6466
• Status: Completed
• Phase: N/A
• First received: November 18, 2011
• Last updated: November 18, 2011
• Start date: November 2007

Study information

• Verified date: November 2011
• Source: Instituto Nacional de Salud Publica, Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: National Institute of Public Health, Health SecretariatMexico: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pregnancy

Intervention

Other:
• PM/ON integration
Professional midwives or obstetric nurses are integrated into clinic staff and delivering services.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Instituto Nacional de Salud Publica, Mexico	Mexican Center for Gender Equity and Reproductive Health, Mexican National Institute for Women, Secretary of Health, Guerrero state, Secretary of Health, Oaxaca state

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of evidence-based practices during labor, delivery, and postpartum care	Will collect data on deliveries ocurring in sites over 21 month period.	21 months	Yes
Primary	volume of prenatal visits, deliveries	We will Assess overall number of first and follow up prenatal visits and deliveries in intervention and control sites	21 months	No
Primary	Use of harmful or unnecessary practices during labor and delivery	We will assess use of harmful or unnecessary practices during labor and delivery	21 months	Yes