Acupuncture for Pain Relief During Induced Labour in Nulliparae

University of Oxford

Status: Completed

Conditions: Pain

Treatments: Procedure: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT01165099

4874

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• nulliparae
• having labour induced for prolonged pregnancy or mild hypertension
• no previous experience of acupuncture
• give written informed consent

Exclusion criteria

• all who do not meet the inclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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105 participants in 4 patient groups

manual acupuncture

Experimental group

Description:

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.

Treatment:

Procedure: acupuncture

electro acupuncture

Experimental group

Description:

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.

Treatment:

Procedure: acupuncture

Sham manual or electro acupuncture

Sham Comparator group

Description:

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.

Treatment:

Procedure: acupuncture

control group

No Intervention group

Description:

Following randomisation to be control group, no specific treatment was organised at this time.