NCT00312585

Brief Summary

The purpose of this study is to assess if acupuncture can shorten the time to delivery for women who are experiencing their first, full-term pregnancy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P25-P50 for phase_2 pregnancy

Timeline
Completed

Started Feb 2005

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

February 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 10, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

April 7, 2016

Status Verified

May 1, 2011

Enrollment Period

2.1 years

First QC Date

April 6, 2006

Last Update Submit

April 5, 2016

Conditions

Pregnancy

Keywords

pregnancyacupuncture

Outcome Measures

Primary Outcomes (1)

  • prevention of inpatient induction of labor

Secondary Outcomes (5)

  • rate of cesarean delivery

  • rates of chorioamnionitis

  • length of maternal hospital stay

  • rates of assisted delivery

  • neonatal outcomes

Study Arms (3)

Acupuncture

EXPERIMENTAL
Procedure: Acupuncture

Sham Acupuncture

SHAM COMPARATOR
Procedure: Sham comparator

Usual care only

NO INTERVENTION

Interventions

AcupuncturePROCEDURE
Acupuncture
Sham comparatorPROCEDURE
Sham Acupuncture

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • first, full-term pregnancy
  • weeks gestation
  • English or Spanish speaking
  • Bishop score of 7 or less

You may not qualify if:

  • uncertain pregnancy dating
  • transportation difficulties
  • previous inability to tolerate acupuncture
  • age less than 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC-Chapel Hill Family Medicine Center

Chapel Hill, North Carolina, 27599-7595, United States

Location

Related Publications (1)

  • Harper TC, Coeytaux RR, Chen W, Campbell K, Kaufman JS, Moise KJ, Thorp JM. A randomized controlled trial of acupuncture for initiation of labor in nulliparous women. J Matern Fetal Neonatal Med. 2006 Aug;19(8):465-70. doi: 10.1080/14767050600730740.

    PMID: 16966110RESULT

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Teresa Harper, MD

    UNC-Chapel Hill Department of Ob/Gyn

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 6, 2006

First Posted

April 10, 2006

Study Start

February 1, 2005

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

April 7, 2016

Record last verified: 2011-05

Locations

US(1)