Use of Acupuncture for Stimulation of Labour

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

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

Inclusion criteria:

1. Normal pregnancy
2. In labour (orificium < 8 cm), 37th week or thereafter
3. Ruptured membranes
4. 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.

Study Overview

• Status: Terminated
• Conditions: Dystocia
• Intervention / Treatment: Device: Acupuncture og acupressure when diagnosed with dystocia

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Pathological pregnancy
2. Pathological labour
3. Medical diseases
4. Women who do not speak and undrestand danish

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

What is the study measuring?

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Herning Hospital
• Collaborators: Ringkjøbing County Research Fond; Union of Midwives Research Fond
• Investigators: Study Chair: Kjeld Rasmussen, obst. dr.med, Obstetric ward Herning and Holstebro hospitals

Study record dates

Study Major Dates

• Study Start: October 1, 2002
• Primary Completion: December 6, 2022
• Study Completion (Actual): March 1, 2007

Study Registration Dates

• First Submitted: January 18, 2006
• First Submitted That Met QC Criteria: January 18, 2006
• First Posted (Estimate): January 19, 2006

Study Record Updates

• Last Update Posted (Estimate): July 4, 2008
• Last Update Submitted That Met QC Criteria: July 1, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: oxytocin; dystocia; stimulation; acupuncture
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Dystocia
• Other Study ID Numbers: 1-Modlock; NCT00279071

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No