Acupuncture for the Prevention of Postdates Pregnancy

Pregnancy Clinical Trial

Official title:

A Randomized Controlled Trial of Acupuncture to Prevent Postdates Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00312585
• Other study ID #: G0418
• Status: Completed
• Phase: Phase 2
• First received: April 6, 2006
• Last updated: April 5, 2016
• Start date: February 2005
• Est. completion date: March 2007

Study information

• Verified date: May 2011
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

There are certain medical conditions that can complicate pregnancies after 40 weeks gestation. However, it is not always safe or easy to put these women into labor. Acupuncture has been used in Asia for hundreds of years to induce contractions and begin the labor process. Acupuncture is not typically used in the United States to induce labor, however. The purpose of this study is to determine whether a series of up to five acupuncture treatments can prevent postdates pregnancy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• first, full-term pregnancy

• 38-41 weeks gestation

• English or Spanish speaking

• Bishop score of 7 or less

Exclusion Criteria:

• uncertain pregnancy dating

• transportation difficulties

• previous inability to tolerate acupuncture

• age less than 18

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy

Intervention

Procedure:
• Acupuncture

• Sham comparator

Locations

Country	Name	City	State
United States	UNC-Chapel Hill Family Medicine Center	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevention of inpatient induction of labor
Secondary	rate of cesarean delivery
Secondary	rates of chorioamnionitis
Secondary	length of maternal hospital stay
Secondary	rates of assisted delivery
Secondary	neonatal outcomes