Acupuncture for Promotion of Timely Delivery - Full Text View

Sponsor:	University of Pennsylvania
Information provided by:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00379327

Purpose

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.

Condition	Intervention	Phase
Delivery, Obstetric	Procedure: Acupuncture Device: Non-puncturing Acupuncture Needle	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Acupuncture for Promotion of Timely Delivery

Resource links provided by NLM:

MedlinePlus related topics: Acupuncture Acute Bronchitis Anxiety Childbirth

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:

timely delivery -- deliver on or before the EDC

Secondary Outcome Measures:

State-Trait Anxiety Index, a self-administered questionnaire for assessment of anxiety
Short Form 36, a self-administered questionnaire for assessment of quality of life status
Modified Bishop's Score obtained to assess cervical ripening
Maternal and newborn outcomes

Enrollment:	103
Study Start Date:	January 2006
Study Completion Date:	August 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Real Accupuncture Acupuncture with a real needle that punctures the skin versus acupuncture needle that does not puncture the skin.	Procedure: Acupuncture Acupuncture administered in last three weeks of pregnancy Other Name: Asia Medicine Produces needle
Placebo Comparator: Non-puncturing Acupuncture Acupuncture needle that touches but does not puncture the skin	Device: Non-puncturing Acupuncture Needle Streitsberg non-Acupuncture Needle Other Name: Asia Medicine produces this needle

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Eligibility

Ages Eligible for Study:	15 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

A singleton pregnancy in cephalic presentation
Between 34 and 37 weeks gestation
Their pregnancy dating (due date) confirmed by at least one first or second trimester ultrasound
No fetal or maternal contraindications to vaginal delivery
No contraindication to carry to EDC (40w 0d)
Have the capacity to understand the requirements of the study

Exclusion Criteria:

Without adequate information of dating
High risk of Cesarean Delivery
Currently receiving acupuncture outside of study
Uncertainty of gestational age dating (according to the chart documentation)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379327

Locations

United States, Delaware
St. Francis Hospital
Wilmington, Delaware, United States, 19805

Sponsors and Collaborators

University of Pennsylvania

Investigators

Study Director:	John T Farrar, MD, PhD	University of Pennsylvania
Principal Investigator:	Rebecca A Greenberg, MD	University of Pennsylvania

More Information

Publications:

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.

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.

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.

Smith CA, Crowther CA. Acupuncture for induction of labour. Cochrane Database Syst Rev. 2004;(1):CD002962. Review.

Responsible Party:	Pamela Caudil, Executive Director, Office of Research Services, P-221 Franklin Bldg. 3451 Walnut Street, Phila, PA
ClinicalTrials.gov Identifier:	NCT00379327 History of Changes
Other Study ID Numbers:	AcuPTD-100
Study First Received:	September 19, 2006
Last Updated:	November 17, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pennsylvania:

Pregnancy
Acupuncture
Pregnancy Outcome
Randomized Controlled Trial
Double-Blind Method

ClinicalTrials.gov processed this record on February 09, 2012