Clinical trial NCT00245752: Can Acupuncture be Used as Preparation for Induction of Labour
Official title: Randomised Study of the Effect of Acupuncture as Induction of Labour
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pregnancy Overdue - Week 41+6
Keywords: post term pregnancy
acupuncture
induction
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
Collaborators: name: Skejby Research Fond
name: Ringkjøbing County Research Fond
name: Union of Midwives Research Fond
First posted: 2005-10-28
Enrollment: 125
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 the study is to evaluate whether acupuncture can be used to ripen cervix before medicinal induction of labor or even be used as method for induction, and thereby eliminating other and more potentially harmful methods.

Detailed description: 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 disruption as result of the use of endocervical balloon catheter. In connection with manual rupture of membranes there is an increased risk of umbilical 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 study group on acupuncture points on hands, feet, ankles 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 criteria: 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

Primary outcomes:
measure: In active delivery or not (over or equal to 3 cm)
timeFrame: 24 hrs
Secondary outcomes:
measure: Degree of dilatation of orificium
timeFrame: 24 hrs
measure: Ruptured membranes or not,
timeFrame: 24 hrs
measure: Increase in uterine activity or not,
timeFrame: 24 hrs
Other outcomes:
Locations:
Study officials:
name: Niels Uldbjerg, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Modlock J, Nielsen BB, Uldbjerg N. Acupuncture for the induction of labour: a double-blind randomised controlled study. BJOG. 2010 Sep;117(10):1255-61. doi: 10.1111/j.1471-0528.2010.02647.x. Epub 2010 Jun 24.