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

This study has been completed.
Sponsor:
Collaborators:
Mexican National Institute for Women
Mexican Center for Gender Equity and Reproductive Health
Secretary of Health, Guerrero state
Secretary of Health, Oaxaca state
Information provided by (Responsible Party):
Dilys Walker, Instituto Nacional de Salud Publica, Mexico
ClinicalTrials.gov Identifier:
NCT01477541
First received: November 18, 2011
Last updated: NA
Last verified: November 2011
History: No changes posted
  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.

Resource links provided by NLM:


Further study details as provided by Instituto Nacional de Salud Publica, Mexico:

Primary Outcome Measures:
  • 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
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01477541

Sponsors and Collaborators
Instituto Nacional de Salud Publica, Mexico
Mexican National Institute for Women
Mexican Center for Gender Equity and Reproductive Health
Secretary of Health, Guerrero state
Secretary of Health, Oaxaca state
Investigators
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 September 18, 2014