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Study of Having a Female Friend as Labor Support

NCT ID: NCT00127361

Last Updated: 2005-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-01-31

Study Completion Date

2003-02-28

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Pregnancy Delivery, Obstetric

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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doula training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Saint Peters University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Della A Campbell, PhDc

Role: PRINCIPAL_INVESTIGATOR

Saint Peters University Hospital

Locations

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Saint Peters University Hospital

New Brunswick, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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DAC-1998

Identifier Type: -

Identifier Source: org_study_id