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Completed

NCT Number: NCT00127361

Study of Having a Female Friend as Labor Support

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.

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Key information

Conditions

Pregnancy Delivery, Obstetric

Age range

16 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Saint Peters University Hospital

New Brunswick, New Jersey, 07109, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

doula training

Behavioral

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

Sponsors and collaborators

Lead sponsor

Saint Peters University Hospital

Other

Registry information

Official study title

Evaluation of Continuous Support in Labor

Important dates

Study start
1998
Study completion
2003
First posted
Aug 5, 2005
Registry last updated
Aug 23, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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