NCT01477541

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable pregnancy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
Last Updated

November 22, 2011

Status Verified

November 1, 2011

Enrollment Period

2.3 years

First QC Date

November 18, 2011

Last Update Submit

November 18, 2011

Conditions

Pregnancy

Keywords

Prenatal careMaternal mortalityPerinatal mortalityPerinatalPuerperiumPuerperium careMidwivesMidwifeObstetricNurseIntegrationAlternative personnelSkilled attendantBirth attendantDeliveryDelivery servicesBest practicesRural

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

PM/ON integration arm

EXPERIMENTAL

Health centers where professional midwives or obstetric nurses are integrated into clinic staff and delivering services.

Other: PM/ON integration

Control

NO INTERVENTION

Interventions

PM/ON integrationOTHER

Professional midwives or obstetric nurses are integrated into clinic staff and delivering services.

PM/ON integration arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Clinics inaccessible by car
  • Clinics undergoing remodeling

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Maternal DeathPerinatal Death

Condition Hierarchy (Ancestors)

Parental DeathDeathPathologic ProcessesPathological Conditions, Signs and SymptomsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Dilys Walker, MD

    Instituto Nacional de Salud Publica, Mexico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investidadora Asociada C

Study Record Dates

First Submitted

November 18, 2011

First Posted

November 22, 2011

Study Start

November 1, 2007

Primary Completion

March 1, 2010

Last Updated

November 22, 2011

Record last verified: 2011-11