Acupuncture for Pain Relief During Induced Labour in Nulliparae

Not Applicable

Completed

• Conditions: Pain
• Interventions: Procedure: acupuncture

• Registration Number: NCT01165099
• Lead Sponsor: University of Oxford

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.

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 Timeline

• Study Start: 2005-08
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Study First Submitted: 2010-07-15
• Study First Submitted QC: 2010-07-16
• Study First Posted: 2010-07-19
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-26
• Last Update Posted: 2019-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
electro acupuncture	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.
manual acupuncture	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.
Sham manual or electro acupuncture	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.

Primary Outcome Measures

Name	Time	Method
the rate of intrapartum epidural analgesia	within 72 hours of trial entry	epidural analgesia administered during labour

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

John Radcliffe Hospital; 🇬🇧 Oxford, United Kingdom