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

November 18, 2011 updated by: Dilys Walker, Instituto Nacional de Salud Publica, Mexico

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
21 months
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
21 months
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
21 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Salud Publica, Mexico

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

November 18, 2011

First Submitted That Met QC Criteria

November 18, 2011

First Posted (Estimate)

November 22, 2011

Study Record Updates

Last Update Posted (Estimate)

November 22, 2011

Last Update Submitted That Met QC Criteria

November 18, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 104-6466

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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