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Study of Having a Female Friend as Labor Support

This study has been completed.
Sponsor:
Information provided by:
Saint Peters University Hospital
ClinicalTrials.gov Identifier:
NCT00127361
First received: August 4, 2005
Last updated: August 22, 2005
Last verified: April 2005
History of Changes
  Purpose

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.


Condition Intervention
Pregnancy
Delivery, Obstetric
 Behavioral: doula training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Continuous Support in Labor

Resource links provided by NLM:

MedlinePlus related topics: Childbirth
U.S. FDA Resources

Further study details as provided by Saint Peters University Hospital:

Primary Outcome Measures:
  • Length of labor
  • type of delivery
  • type and timing of analgesia/anesthesia

Secondary Outcome Measures:
  • Birthweight
  • neonatal Apgar score at 1 and 5 minutes after birth

Estimated Enrollment: 600
Study Start Date: January 1998
Estimated Study Completion Date: February 2003
Detailed Description:

The purpose of this study was to evaluate the influence of a female companion in labor who had been chosen by a nulliparous, underinsured, low-income woman and who had received brief training in supportive labor techniques. The objective was to compare labor outcomes, specifically cesarean section rates, in women accompanied by this additional support person (doula group) with outcomes in women who did not have this additional support person (control group).

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Placenta previa
  • Abruptio placenta
  • Multiple pregnancy
  • Breech presentation
  • Planned operative delivery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127361

Locations
United States, New Jersey
Saint Peters University Hospital
New Brunswick, New Jersey, United States, 07109
Sponsors and Collaborators
Saint Peters University Hospital
Investigators
Principal Investigator: Della A Campbell, PhDc Saint Peters University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00127361     History of Changes
Other Study ID Numbers: DAC-1998
Study First Received: August 4, 2005
Last Updated: August 22, 2005
Health Authority: United States: Institutional Review Board

Keywords provided by Saint Peters University Hospital:
doula
caregivers
labor support
being with woman
 continuous labor support
maternal outcomes
Parturition

ClinicalTrials.gov processed this record on June 17, 2013