Use of Acupuncture for Stimulation of Labour | NCT00279071

Studies
Use of Acupuncture for Stimulation of Labour

NCT00279071

Sponsor

Herning Hospital

Status

Terminated

Last Update Posted

Jul 4, 2008Estimated

Enrollment

100Actual

Phase

Phase 2

Conditions

Dystocia

Interventions

Acupuncture og acupressure when diagnosed with dystocia

Countries

Not provided

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

ID	Type	Description	Link
NCT00279071

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

exhausted personel after a long recruiting period

Expanded Access Info

Start Date

Oct 2002

Primary Completion Date

Not provided

Completion Date

Mar 2007Actual

First Submitted Date

Jan 18, 2006

First Submission Date that Met QC Criteria

Jan 18, 2006

First Posted Date

Jan 19, 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

Jul 1, 2008

Last Update Posted Date

Jul 4, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Herning HospitalOTHER

Collaborators

Name	Class
Ringkjøbing County Research Fond	UNKNOWN
Union of Midwives Research Fond	OTHER

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

Hypothesis:Acupuncture can be used as stimulation of labour in case of primary og secondary inertia.

A randomized controlled trial including 150 pregnant women Acupuncture has become a natural part of the range of obstetric treatments offered in danish delivery wards, but there is only little evidence to the effect of the acupuncture.

The women are randomized into to groups.

Acupuncture, Acu.points: KI3, Ki6, SP6, BL60, LI4, BL67(acupressure)
No treatment

The women will be asked in case beginning signs of inertia, if they want to parcipitate in the trial.

Inclusion criteria:

Normal pregnancy
In labour (orificium < 8 cm), 37th week or thereafter
Ruptured membranes
Primary or secondary inertia

The women will just before randomization be vaginally explored and fetal heart monitored. The meassure of effect happens two hours after randomization.

The midwife who measures the effect, is blinded to the treatment or lack of, and also on the including exploration.

Secondary effect meassures: length of labour, use of oxytocin and number of contracions pr/min meassured twice:

1. before the randomization and again 1 hour after randomization.

Detailed Description

Not provided

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

100Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acupuncture og acupressure when diagnosed with dystocia	Device	Acupuncture points: sp6 li4 ki3 ki6 bl60 Acupressure points: bl67

Outcomes Module

Primary Outcomes

Not provided

Secondary Outcomes

Measure	Description	Time Frame
use of oxytocin		additional need for oxytocin infusion in 1. stage and 2. stage
number of contractions/30 minutes		number og contractions in 1st. stage and 2nd. stage

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Normal pregnancy
In labour (orificium < 8 cm), 37th week or thereafter
Ruptured membranes
Primary or secondary inertia -

Exclusion Criteria:

Pathological pregnancy
Pathological labour
Medical diseases
Women who do not speak and undrestand danish

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kjeld Rasmussen, obst. dr.med	Obstetric ward Herning and Holstebro hospitals	Study Chair

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004420	Dystocia

Ancestor Terms

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

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