NCT00127361

Brief Summary

The purpose of this study was to compare labor outcomes in women accompanied by an additional support person (doula group) with outcomes in women who did not have this additional support person (control group). The current study was designed with the benefits of continuous labor support in mind as well as the need for a cost-effective, affordable program to provide those services for low-income women. Its purpose was to evaluate the effects of continuous labor support provided by a female companion of the pregnant person's choosing who, with the mother, had participated in an educational program to teach her how to provide continuous labor support.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started Jan 1998

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

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

January 1, 1998

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2005

Completed
Last Updated

August 23, 2005

Status Verified

April 1, 2005

First QC Date

August 4, 2005

Last Update Submit

August 22, 2005

Conditions

PregnancyDelivery, Obstetric

Keywords

doulacaregiverslabor supportbeing with womancontinuous labor supportmaternal outcomesParturition

Outcome Measures

Primary Outcomes (3)

  • Length of labor

  • type of delivery

  • type and timing of analgesia/anesthesia

Secondary Outcomes (2)

  • Birthweight

  • neonatal Apgar score at 1 and 5 minutes after birth

Interventions

doula trainingBEHAVIORAL

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Nulliparous (never given birth before)
  • Singleton pregnancy
  • Vertex presentation
  • Low risk pregnancy
  • Has a female friend willing to be a doula

You may not qualify if:

  • Placenta previa
  • Abruptio placenta
  • Multiple pregnancy
  • Breech presentation
  • Planned operative delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Peters University Hospital

New Brunswick, New Jersey, 07109, United States

Location

Study Officials

  • Della A Campbell, PhDc

    Saint Peters University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 4, 2005

First Posted

August 5, 2005

Study Start

January 1, 1998

Study Completion

February 1, 2003

Last Updated

August 23, 2005

Record last verified: 2005-04

Locations

US(1)