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Acupuncture for Promotion of Timely Delivery

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ClinicalTrials.gov Identifier: NCT00379327
Recruitment Status : Completed
First Posted : September 21, 2006
Last Update Posted : November 18, 2010
Sponsor:
Information provided by:
University of Pennsylvania

Brief Summary:
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 or disease Intervention/treatment Phase
Delivery, Obstetric Procedure: Acupuncture Device: Non-puncturing Acupuncture Needle Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture for Promotion of Timely Delivery
Study Start Date : January 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. timely delivery -- deliver on or before the EDC

Secondary Outcome Measures :
  1. State-Trait Anxiety Index, a self-administered questionnaire for assessment of anxiety
  2. Short Form 36, a self-administered questionnaire for assessment of quality of life status
  3. Modified Bishop's Score obtained to assess cervical ripening
  4. Maternal and newborn outcomes


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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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