Delivery, Obstetric Clinical Trial
Official title:
Acupuncture for Promotion of Timely Delivery
NCT number | NCT00379327 |
Other study ID # | AcuPTD-100 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | January 2006 |
Est. completion date | August 2007 |
Verified date | October 2010 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study of 100 pregnant women is to determine if acupuncture using real needles that puncture the skin, starting at thirty seven weeks three days estimated gestational age (EGA), will increase the percentage of women delivering on or before the estimated date of confinement (EDC = 40 weeks EGA), compared with women treated identically but with placebo needles that do not puncture the skin.
Status | Completed |
Enrollment | 103 |
Est. completion date | August 2007 |
Est. primary completion date | August 2007 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 15 Years to 50 Years |
Eligibility |
Inclusion Criteria: 1. A singleton pregnancy in cephalic presentation 2. Between 34 and 37 weeks gestation 3. Their pregnancy dating (due date) confirmed by at least one first or second trimester ultrasound 4. No fetal or maternal contraindications to vaginal delivery 5. No contraindication to carry to EDC (40w 0d) 6. Have the capacity to understand the requirements of the study Exclusion Criteria: 1. Without adequate information of dating 2. High risk of Cesarean Delivery 3. Currently receiving acupuncture outside of study 4. Uncertainty of gestational age dating (according to the chart documentation) |
Country | Name | City | State |
---|---|---|---|
United States | St. Francis Hospital | Wilmington | Delaware |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
Caughey AB, Bishop JT. Maternal complications of pregnancy increase beyond 40 weeks of gestation in low-risk women. J Perinatol. 2006 Sep;26(9):540-5. Epub 2006 Jul 13. — View Citation
Caughey AB, Nicholson JM, Cheng YW, Lyell DJ, Washington AE. Induction of labor and cesarean delivery by gestational age. Am J Obstet Gynecol. 2006 Sep;195(3):700-5. — View Citation
Rabl M, Ahner R, Bitschnau M, Zeisler H, Husslein P. Acupuncture for cervical ripening and induction of labor at term--a randomized controlled trial. Wien Klin Wochenschr. 2001 Dec 17;113(23-24):942-6. — View Citation
Smith CA, Crowther CA. Acupuncture for induction of labour. Cochrane Database Syst Rev. 2004;(1):CD002962. Review. Update in: Cochrane Database Syst Rev. 2013;8:CD002962. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | timely delivery -- deliver on or before the EDC | |||
Secondary | State-Trait Anxiety Index, a self-administered questionnaire for assessment of anxiety | |||
Secondary | Short Form 36, a self-administered questionnaire for assessment of quality of life status | |||
Secondary | Modified Bishop's Score obtained to assess cervical ripening | |||
Secondary | Maternal and newborn outcomes |
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