|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Skejby Hospital Skejby Research Fond Ringkjøbing County Research Fond Union of Midwives Research Fond |
| Information provided by: | Skejby Hospital |
| ClinicalTrials.gov Identifier: | NCT00245752 |
Purpose
The purpose of the study is to evaluate whether acupuncture can be used to ripen cervix before medicinal induction of labour or even be used as method for induction, and thereby eliminating other and more potentielly harmful methods.
| Condition | Intervention | Phase |
|
Pregnancy Overdue - Week 41+6 |
Procedure: acupuncture |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Estimated Enrollment: | 124 |
| Study Start Date: | November 2005 |
| Estimated Study Completion Date: | December 2006 |
Acupuncture has become a natural part of the range of treatments in obstetric departments in Denmark, but there is only little evidence to the effect of acupuncture.
Many of the induction procedures currently in use in Denmark also have a little risk of side effects. to mention a few: There is a increased risk of maternal and neonatal infection, bleeding, ruptured membranes and placental disruptio as result of the use of endocervical ballon catheter. In connection with manual rupture of membranes there is an increased risk of umbillical prolapse, maternal and neonatal infection, affected fetal heart rate, scratches on the scalp and placental bleeding. By using misoprostol there has been seen hyperstimulation of uterus causing affected fetal heart rate.
Many women are asking for alternatives to the existing methods used in obstetric dept.s.
In order to assess the effect, or lack of, acupuncture might have, we want to use acupuncture in the studygroup on acupuncture points on hands, feet, ancles and back of the head. The control group will get placebo acupuncture needles on same locations. The included women will be treated with the kind of acupuncture that counts for the group to which shes been allocated on gestational age 41+6 at 8:00 am and 2:30 pm.
Eligibility
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:gestational age 41+6 Normal pregnancy, expecting a healthy baby Verified due date
Exclusion Criteria:
women who do not speak or understand Danish multiple pregnancy In active labour previous sectio maternal diseases (i.e. Diabetes, preeclampsia, heart diseases) fetal diseases (i.e. foetus mors, IUGR, hydrocephalus) previous complicated delivery i.e. low Apgar score Allergic to metal Anticoagulatory treatment
-
Contacts and Locations| Contact: Jette Modlock, develop midw | 45-99276356 | jemod@ringamt.dk |
| Denmark | |||||
| Skejby Hospital | Recruiting | ||||
| Århus, Denmark, 8000 | |||||
| Contact: Jette Modlock, develop midw 45 99276356 jemod@ringamt.dk | |||||
| Skejby Hospital |
| Skejby Research Fond |
| Ringkjøbing County Research Fond |
| Union of Midwives Research Fond |
| Principal Investigator: | Niels Uldbjerg, Professor | unaffiliated |
More Information
| Study ID Numbers: | 20040001 |
| First Received: | October 26, 2005 |
| Last Updated: | February 1, 2006 |
| ClinicalTrials.gov Identifier: | NCT00245752 |
| Health Authority: | Denmark: Ethics Committee |
|
|