Acupuncture for Pain Relief During Induced Labour in Nulliparae

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Procedure: acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: manual acupuncture<br>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<br>* The description of the acupuncture, whether manual, electro or sham, is as described for each of the individual groups.<br>* Other names: Electronic Acupunctuscope AWQ-104L digital.;|
| Experimental: electro acupuncture<br>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<br>* The description of the acupuncture, whether manual, electro or sham, is as described for each of the individual groups.<br>* Other names: Electronic Acupunctuscope AWQ-104L digital.;|
| Sham Comparator: Sham manual or electro acupuncture<br>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<br>* The description of the acupuncture, whether manual, electro or sham, is as described for each of the individual groups.<br>* Other names: Electronic Acupunctuscope AWQ-104L digital.;|
| No Intervention: control group<br>Following randomisation to be control group, no specific treatment was organised at this time. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of intrapartum epidural analgesia | epidural analgesia administered during labour | within 72 hours of trial entry | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the outcome of labour | the outcomes of labour included: parenteral analgesia requirement, labour length, delivery mode, neonatal condition and postpartum haemorrhage | within 72 hours of trial entry | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, induced labour, labour outcome, nulliparae, pain-relief, epidural during labour