Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Study of Having a Female Friend as Labor Support

This study has been completed.
Information provided by:
Saint Peters University Hospital Identifier:
First received: August 4, 2005
Last updated: August 22, 2005
Last verified: April 2005

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
Delivery, Obstetric
Behavioral: doula training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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).

Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00127361

United States, New Jersey
Saint Peters University Hospital
New Brunswick, New Jersey, United States, 07109
Sponsors and Collaborators
Saint Peters University Hospital
Principal Investigator: Della A Campbell, PhDc Saint Peters University Hospital
  More Information Identifier: NCT00127361     History of Changes
Other Study ID Numbers: DAC-1998
Study First Received: August 4, 2005
Last Updated: August 22, 2005

Keywords provided by Saint Peters University Hospital:
labor support
being with woman
continuous labor support
maternal outcomes
Parturition processed this record on May 25, 2017