Study of Having a Female Friend as Labor Support | NCT00127361

Studies
Study of Having a Female Friend as Labor Support

NCT00127361

Sponsor

Saint Peters University Hospital

Status

Completed

Last Update Posted

Aug 23, 2005Estimated

Enrollment

600

Phase

Not Applicable

Conditions

Pregnancy
Delivery, Obstetric

Interventions

doula training

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1998

Primary Completion Date

Not provided

Completion Date

Feb 2003

First Submitted Date

Aug 4, 2005

First Submission Date that Met QC Criteria

Aug 4, 2005

First Posted Date

Aug 5, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2005

Last Update Posted Date

Aug 23, 2005Estimated

Description Module

Brief 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.

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600

Name	Type	Description	Arm Group Labels	Other Names
doula training	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Length of labor
type of delivery
type and timing of analgesia/anesthesia

Secondary Outcomes

Measure	Description	Time Frame
Birthweight
neonatal Apgar score at 1 and 5 minutes after birth

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Della A Campbell, PhDc	Saint Peters University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Saint Peters University Hospital		New Brunswick	New Jersey	07109	United States