NCT00245752

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2005

Typical duration for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2005

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

February 5, 2009

Status Verified

February 1, 2009

Enrollment Period

2.7 years

First QC Date

October 26, 2005

Last Update Submit

February 4, 2009

Conditions

Pregnancy Overdue - Week 41+6

Keywords

post term pregnancyacupunctureinduction

Outcome Measures

Primary Outcomes (1)

  • In active delivery or not (over or equal to 3 cm)

    24 hrs

Secondary Outcomes (3)

  • Degree of dilatation of orificium

    24 hrs

  • Ruptured membranes or not,

    24 hrs

  • Increase in uterine activity or not,

    24 hrs

Study Arms (2)

A

ACTIVE COMPARATOR

in points bilaterally inBL 67, LI 4, SP6, one in GV20.

Device: acupuncture

2

SHAM COMPARATOR

sham acupuncture

Device: acupuncture

Interventions

acupunctureDEVICE

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

Also known as: Seirin Steel needles, and Park Sham needles
2A

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Gestational age 41+6
  • Normal pregnancy, expecting a healthy baby
  • Verified due date

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 20573151DERIVED

MeSH Terms

Conditions

Pregnancy, Prolonged

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Niels Uldbjerg, Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 26, 2005

First Posted

October 28, 2005

Study Start

November 1, 2005

Primary Completion

July 1, 2008

Study Completion

December 1, 2008

Last Updated

February 5, 2009

Record last verified: 2009-02