Acupuncture for Pain Relief During Induced Labour in Nulliparae

Sponsor

University of Oxford (Other)

Overall Status

Completed

CT.gov ID

NCT01165099

Collaborator

(none)

105

Enrollment

Location

Arms

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study was primarily designed to assess the role of acupuncture in reducing the need for epidural analgesia for pain relief during induced labour. The other outcomes of labour were to be observed in addition.

Condition or Disease	Intervention/Treatment	Phase
Pain	Procedure: acupuncture	N/A

Detailed Description

The study was limited to women in their first pregnancy having labour induced for prolonged pregnancy or mild hypertension. The study involved randomised groups managed with manual acupuncture, electro acupuncture, sham acupuncture and a no-treatment control group.

Study Design

Study Type:

Interventional

Actual Enrollment :

105 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Acupuncture for Pain Relief During Induced Labour in Nulliparae: a Randomised Controlled Study

Study Start Date :

Aug 1, 2005

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: manual acupuncture Sterile needles were inserted intramuscularly to a depth of 15-20mm until an unusual (De-Qi) sensation developed and remained inserted for 30-60 minutes and were manually manipulated during this time. The following bilateral acupoints on the hands and feet at Hegu (LI 4), Sanyinjiao (Sp 6) Kunlun (BL 60) and Zhiyin (BL 67)were used.	Procedure: acupuncture The description of the acupuncture, whether manual, electro or sham, is as described for each of the individual groups. Other Names: Disposable needles Seirin DN04 0.20x30mm - 0.30x50mm. Electronic Acupunctuscope AWQ-104L digital.
Experimental: electro acupuncture Sterile needles were inserted intramuscularly to a depth of 15-20mm until an unusual (De-Qi) sensation developed and remained inserted for 30-60 minutes and were either electronically simulated withm2 Hz pulses of 0.5 msec duration for 30 minutes sufficient to cause non-painful muscle contractions. The following bilateral acupoints on the hands and feet at Hegu (LI 4), Sanyinjiao (Sp 6) Kunlun (BL 60) and Zhiyin (BL 67)were used.	Procedure: acupuncture The description of the acupuncture, whether manual, electro or sham, is as described for each of the individual groups. Other Names: Disposable needles Seirin DN04 0.20x30mm - 0.30x50mm. Electronic Acupunctuscope AWQ-104L digital.
Sham Comparator: Sham manual or electro acupuncture Sterile needles were inserted adjacent to the specific acupuncture sites identified for the manual and electro groups to a depth of 1-1.5mm only and insufficient to provoke an unusual sensation and left in position for a 30-60 minutes. Those randomised to 'sham-manual' received no stimulation and those randomised to 'sham-electro' were connected to the electrical stimulator but the current not activated.	Procedure: acupuncture The description of the acupuncture, whether manual, electro or sham, is as described for each of the individual groups. Other Names: Disposable needles Seirin DN04 0.20x30mm - 0.30x50mm. Electronic Acupunctuscope AWQ-104L digital.
No Intervention: control group Following randomisation to be control group, no specific treatment was organised at this time.

Outcome Measures

Primary Outcome Measures

the rate of intrapartum epidural analgesia [within 72 hours of trial entry]
epidural analgesia administered during labour

Secondary Outcome Measures

the outcome of labour [within 72 hours of trial entry]
the outcomes of labour included: parenteral analgesia requirement, labour length, delivery mode, neonatal condition and postpartum haemorrhage