NCT00379327

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

August 22, 2019

Status Verified

October 1, 2010

Enrollment Period

1.6 years

First QC Date

September 19, 2006

Last Update Submit

August 21, 2019

Conditions

Delivery, Obstetric

Keywords

PregnancyAcupuncturePregnancy OutcomeRandomized Controlled TrialDouble-Blind Method

Outcome Measures

Primary Outcomes (1)

  • timely delivery -- deliver on or before the EDC

Secondary Outcomes (4)

  • 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

Study Arms (2)

Real Accupuncture

EXPERIMENTAL

Acupuncture with a real needle that punctures the skin versus acupuncture needle that does not puncture the skin.

Procedure: Acupuncture

Non-puncturing Acupuncture

PLACEBO COMPARATOR

Acupuncture needle that touches but does not puncture the skin

Device: Non-puncturing Acupuncture Needle

Interventions

AcupuncturePROCEDURE

Acupuncture administered in last three weeks of pregnancy

Also known as: Asia Medicine Produces needle
Real Accupuncture
Non-puncturing Acupuncture NeedleDEVICE

Streitsberg non-Acupuncture Needle

Also known as: Asia Medicine produces this needle
Non-puncturing Acupuncture

Eligibility Criteria

Age15 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Francis Hospital

Wilmington, Delaware, 19805, United States

Location

Related Publications (4)

  • 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. doi: 10.1016/j.ajog.2006.07.003.

    PMID: 16949399BACKGROUND

  • 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. doi: 10.1038/sj.jp.7211560. Epub 2006 Jul 13.

    PMID: 16837930BACKGROUND

  • 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.

    PMID: 11802511BACKGROUND

  • Smith CA, Crowther CA. Acupuncture for induction of labour. Cochrane Database Syst Rev. 2004;(1):CD002962. doi: 10.1002/14651858.CD002962.pub2.

    PMID: 14973999BACKGROUND

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • John T Farrar, MD, PhD

    University of Pennsylvania

    STUDY DIRECTOR

  • Rebecca A Greenberg, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 19, 2006

First Posted

September 21, 2006

Study Start

January 1, 2006

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

August 22, 2019

Record last verified: 2010-10

Locations

US(1)