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CompletedNCT00127361Updated Aug 23, 2005

Study of Having a Female Friend as Labor Support

An interventional study of doula training in Pregnancy and Delivery, Obstetric, sponsored by Saint Peters University Hospital. Completed at 1 site in United States. Open to female participants aged 16 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2005-08-23.

Sponsored by Saint Peters University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
16 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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).

02

Conditions studied

  • Pregnancy
  • Delivery, Obstetric

Keywords

  • doula
  • caregivers
  • labor support
  • being with woman
  • continuous labor support
  • maternal outcomes
  • Parturition
03

In context

Lead sponsor

Saint Peters University Hospital is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 45 Years
Sexes eligible
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

Exclusion Criteria:

  • Placenta previa
  • Abruptio placenta
  • Multiple pregnancy
  • Breech presentation
  • Planned operative delivery
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
600 participants

Interventions

  • Behavioraldoula training
06

What researchers measure

Primary outcomes

  1. Length of labor

  2. type of delivery

  3. type and timing of analgesia/anesthesia

Secondary outcomes

  1. Birthweight

  2. neonatal Apgar score at 1 and 5 minutes after birth

07

Study locations

1 site
  • Saint Peters University Hospital
    New Brunswick, New Jersey 07109, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00127361
Lead sponsor
Saint Peters University Hospital
First posted
Aug 5, 2005
Start date
Jan 1998
Completion
Feb 2003
Last update
Aug 23, 2005

Study contacts

Della A Campbell, PhDc
principal investigator · Saint Peters University Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2005. You cannot join it, but the record below documents what was studied.

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