Clinical trial NCT00261755: Acupuncture as Pain Relief and Relaxation During Childbirth
Official title: Acupuncture as Pain Relief and Relaxation During Childbirth. A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acupuncture Analgesia
Natural Childbirth
Keywords: Acupuncture
pain relief
labour
randomized controlled trial
TENS
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital Skejby
name: Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation
name: Direktør E. Danielsen og Hustrus Fond
name: Kong Christian den Tiendes Fond
name: Lundbeck Foundation
name: Manufacturer Mads Clausen Foundation
name: Else og Mogens Wedell-Wedellsborgs Fond
name: The Hede Nielsen Family Foundation
name: Videns- og Forskningscenter for Alternativ Behandling
name: DADJ (Den almindelige Danske Jordemoderforening)
First posted: 2005-12-05
Enrollment: 607
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of acupuncture for pain relief and relaxation during childbirth.

Detailed description: The purpose of this study is to investigate the effect of acupuncture for pain relief an relaxation during childbirth.

In a controlled study 607 healthy patients in active labor at term are randomly assigned to receive either acupuncture, TENS or traditional analgesia. Pharmacological analgesia is provided on request. The treatment is administered by midwives trained in acupuncture and TENS. The objective parameter of outcome is the need for conventional analgesia in each group. Visual analogue scale assessments are used to evaluate participants perception of pain before, during and after treatment. Questionnaires filled out two months after delivery is used to investigate the patients experience and satisfaction with delivery and analgesia.

Eligibility criteria: Inclusion Criteria:

* Healthy, Danish speaking women with a normal singleton pregnancy giving birth at term 37 - 42 weeks) with a fetus in cephalic presentation.

Exclusion Criteria:

* Women with medical diseases or complicated pregnancy. Women who has already received conventional analgesia during labor.

Primary outcomes:
measure: The need for conventional analgesic in each group.
timeFrame: during labor
Secondary outcomes:
measure: Obstetric outcome: duration of labour, use of oxytocin, incidence of caesarean section, bleeding, apgar score, cord blood pH
timeFrame: from randomization until birth
measure: visual analogue scale is used to evaluate subjective effect on pain.
timeFrame: Just before randomization, one hour after randomization and subsequently every two hours until the child was born
measure: Questionaries filled out by the parturients to investigate satisfactory with analgesic given.
timeFrame: two months after delivery
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Dept Obstetrics, Aarhus University Hospital, Skejby
Study officials:
affiliation: Department of Obstetrics, Aarhus University Hospital, Skejby, Denmark
name: Lone Hvidman, MD,PhD
role: STUDY_CHAIR
affiliation: Department Obstetrics, Rigshospitalet, Denmark
name: Morten Hedegaard, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Obstetrics, Aarhus University Hospital, Skejby
name: Lissa Borup, Midwife
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of obstetrics, Aarhus University Hospital, Skejby
name: Winnie M. Wurlitzer, Midwife
role: PRINCIPAL_INVESTIGATOR
References: