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Study of Having a Female Friend as Labor Support

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00127361
First Posted: August 5, 2005
Last Update Posted: December 9, 2005
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.
Information provided by:
Saint Peters University Hospital
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Continuous Support in Labor

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes 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
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): 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

ClinicalTrials.gov Identifier: NCT00127361     History of Changes
Other Study ID Numbers: DAC-1998
First Submitted: August 4, 2005
First Posted: August 5, 2005
Last Update Posted: December 9, 2005
Last Verified: April 2005

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