Skip to content

Can Acupuncture be Used as Preparation for Induction of Labour

Randomised Study of the Effect of Acupuncture as Induction of Labour

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00245752
Enrollment
125
Registered
2005-10-28
Start date
2005-11-30
Completion date
2008-12-31
Last updated
2009-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Overdue - Week 41+6

Keywords

post term pregnancy, acupuncture, induction

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.

Interventions

DEVICEacupuncture

acupuncture in points bilaterally: BL 67, LI 4, SP6, one in GV20.

Sponsors

Skejby Research Fond
CollaboratorUNKNOWN
Ringkjøbing County Research Fond
CollaboratorUNKNOWN
Union of Midwives Research Fond
CollaboratorOTHER
Aarhus University Hospital Skejby
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
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

Design outcomes

Primary

MeasureTime frame
In active delivery or not (over or equal to 3 cm)24 hrs

Secondary

MeasureTime frame
Degree of dilatation of orificium24 hrs
Ruptured membranes or not,24 hrs
Increase in uterine activity or not,24 hrs

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026