Acupuncture for the Prevention of Postdates Pregnancy | NCT00312585

Studies
Acupuncture for the Prevention of Postdates Pregnancy

NCT00312585

Sponsor

University of North Carolina, Chapel Hill

Status

Completed

Last Update Posted

Apr 7, 2016Estimated

Enrollment

89Actual

Phase

Phase 2

Conditions

Pregnancy

Interventions

Acupuncture
Sham comparator

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2005

Primary Completion Date

Mar 2007Actual

Completion Date

Mar 2007Actual

First Submitted Date

Apr 6, 2006

First Submission Date that Met QC Criteria

Apr 6, 2006

First Posted Date

Apr 10, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2016

Last Update Posted Date

Apr 7, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

89Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Acupuncture	Experimental	Procedure: Acupuncture
Sham Acupuncture	Sham Comparator	Procedure: Sham comparator
Usual care only	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acupuncture	Procedure		Acupuncture
Sham comparator

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
prevention of inpatient induction of labor

Secondary Outcomes

Measure	Description	Time Frame
rate of cesarean delivery
rates of chorioamnionitis
length of maternal hospital stay

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Teresa Harper, MD	UNC-Chapel Hill Department of Ob/Gyn	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UNC-Chapel Hill Family Medicine Center		Chapel Hill	North Carolina	27599-7595	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16966110	Result	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.

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics