Pregnancy Clinical Trial
Official title:
Evaluation of Continuous Support in Labor
Verified date | April 2005 |
Source | Saint Peters University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 600 |
Est. completion date | February 2003 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years to 45 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Saint Peters University Hospital | New Brunswick | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Saint Peters University Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Length of labor | |||
Primary | type of delivery | |||
Primary | type and timing of analgesia/anesthesia | |||
Secondary | Birthweight | |||
Secondary | neonatal Apgar score at 1 and 5 minutes after birth |
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