Natural Childbirth Clinical Trial
Official title:
Acupuncture as Pain Relief and Relaxation During Childbirth. A Randomized Controlled Study
Verified date | May 2008 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Ethics Committee |
Study type | Interventional |
The purpose of this study is to investigate the effect of acupuncture for pain relief and relaxation during childbirth.
Status | Completed |
Enrollment | 607 |
Est. completion date | May 2004 |
Est. primary completion date | February 2004 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Dept Obstetrics, Aarhus University Hospital, Skejby | Aarhus |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Aarhus University Hospital Skejby, DADJ (Den almindelige Danske Jordemoderforening), Direktør E. Danielsen og Hustrus Fond, Else og Mogens Wedell-Wedellsborgs Fond, Fabrikant Mads Clausens Fond, Hede Nielsen, Kong Christian den Tiendes Fond, Lundbeck Foundation, Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation, Videns- og Forskningscenter for Alternativ Behandling |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The need for conventional analgesic in each group. | during labor | Yes | |
Secondary | Obstetric outcome: duration of labour, use of oxytocin, incidence of caesarean section, bleeding, apgar score, cord blood pH | from randomization until birth | Yes | |
Secondary | visual analogue scale is used to evaluate subjective effect on pain. | Just before randomization, one hour after randomization and subsequently every two hours until the child was born | Yes | |
Secondary | Questionaries filled out by the parturients to investigate satisfactory with analgesic given. | two months after delivery | Yes |
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