Use of Acupuncture for Stimulation of Labour

Dystocia Clinical Trial

Official title:

Use of Acupuncture for Stimulation of Labour

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00279071
• Other study ID #: 1-Modlock
• Status: Terminated
• Phase: Phase 2
• First received: January 18, 2006
• Last updated: July 1, 2008
• Start date: October 2002
• Est. completion date: March 2007

Study information

• Verified date: July 2008
• Source: Herning Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dystocia

Intervention

Device:
• Acupuncture og acupressure when diagnosed with dystocia
Acupuncture points: sp6 li4 ki3 ki6 bl60 Acupressure points: bl67

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Herning Hospital	Ringkjøbing County Research Fond, Union of Midwives Research Fond

Outcome

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