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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01477541
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : November 22, 2011
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Pregnancy Other: PM/ON integration

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Incorporation of Alternative Providers for Care During Pregnancy, Delivery and Postpartum in Rural Public Health Clinics.
Study Start Date : November 2007
Primary Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Use of evidence-based practices during labor, delivery, and postpartum care [ Time Frame: 21 months ]
    Will collect data on deliveries ocurring in sites over 21 month period.

  2. volume of prenatal visits, deliveries [ Time Frame: 21 months ]
    We will Assess overall number of first and follow up prenatal visits and deliveries in intervention and control sites

  3. Use of harmful or unnecessary practices during labor and delivery [ Time Frame: 21 months ]
    We will assess use of harmful or unnecessary practices during labor and delivery


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: November 22, 2011
Last Verified: November 2011

Keywords provided by Dilys Walker, 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