Acupuncture for Promotion of Timely Delivery

This study has been completed.
Sponsor:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00379327
First received: September 19, 2006
Last updated: November 17, 2010
Last verified: October 2010
  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 3

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:


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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 September 22, 2014