NCT00279071

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.

  1. 1.Acupuncture, Acu.points: KI3, Ki6, SP6, BL60, LI4, BL67(acupressure)
  2. 2.No treatment
  3. 3.Normal pregnancy
  4. 4.In labour (orificium \< 8 cm), 37th week or thereafter
  5. 5.Ruptured membranes
  6. 6.Primary or secondary inertia

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2002

Typical duration for phase_2

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2006

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

July 4, 2008

Status Verified

July 1, 2008

First QC Date

January 18, 2006

Last Update Submit

July 1, 2008

Conditions

Dystocia

Keywords

dystociastimulationacupunctureoxytocin

Outcome Measures

Secondary Outcomes (2)

  • 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

Interventions

Acupuncture og acupressure when diagnosed with dystociaDEVICE

Acupuncture points: sp6 li4 ki3 ki6 bl60 Acupressure points: bl67

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dystocia

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Kjeld Rasmussen, obst. dr.med

    Obstetric ward Herning and Holstebro hospitals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 18, 2006

First Posted

January 19, 2006

Study Start

October 1, 2002

Study Completion

March 1, 2007

Last Updated

July 4, 2008

Record last verified: 2008-07