Pregnancy Overdue - Week 41+6Phase 2NCT00245752
Can Acupuncture be Used as Preparation for Induction of Labour
A Phase 2 study testing acupuncture in people with Pregnancy Overdue - Week 41+6, run by Aarhus University Hospital Skejby.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Overdue - Week 41+6
- What is being tested?
- acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- Nov 2005to Dec 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Gestational age 41+6
- Normal pregnancy, expecting a healthy baby
- Verified due date
Who cannot join
- 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)
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- Previous complicated delivery i.e. low Apgar score
- Allergic to metal
- Anticoagulatory treatment
About this study
Official title: Randomised Study of the Effect of Acupuncture as Induction of Labour
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.
Read the 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.
- Conditions
- Pregnancy Overdue - Week 41+6
- Being tested
- acupuncture
- Keywords
- post term pregnancy, acupuncture, induction
- Medical subject headings
- Pregnancy, Prolonged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureDevice
Also called Seirin Steel needles, and Park Sham needles
acupuncture in points bilaterally: BL 67, LI 4, SP6, one in GV20.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | in points bilaterally inBL 67, LI 4, SP6, one in GV20. Receives: Device: acupuncture |
| 2 | Sham comparator | sham acupuncture Receives: Device: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
In active delivery or not (over or equal to 3 cm)
Measured: 24 hrs
Secondary outcomes (3)
Degree of dilatation of orificium
Measured: 24 hrs
Ruptured membranes or not,
Measured: 24 hrs
Increase in uterine activity or not,
Measured: 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2005 (estimated)
- Study startNov 2005
- Primary completionJul 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy Overdue - Week 41+6Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital Skejby
- Sponsor type
- University, hospital or other
- Collaborators
- Skejby Research Fond, Ringkjøbing County Research Fond, Union of Midwives Research Fond
- Investigators
- Niels Uldbjerg, Professor, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00245752
- Sponsor's protocol ID
- 20040001
- Status last verified
- Feb 2009
- First submitted
- 26 Oct 2005
- Last updated
- 5 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20573151
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Study of the Effect of Acupuncture as Induction of Labour
- ClinicalTrials.gov ID
- NCT00245752
- Acronym / sponsor ID
- 20040001
- Conditions
- Pregnancy Overdue - Week 41+6
- Keywords
- post term pregnancy, acupuncture, induction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Aarhus University Hospital SkejbyUniversity, hospital or other
- Collaborators
- Skejby Research Fond, Ringkjøbing County Research Fond, Union of Midwives Research Fond
- Study start
- Nov 2005
- Primary completion
- Jul 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 28 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Device: acupuncturein points bilaterally inBL 67, LI 4, SP6, one in GV20. |
| 2 | Sham comparator | Device: acupuncturesham acupuncture |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Gestational age 41+6
- Normal pregnancy, expecting a healthy baby
- Verified due date
Key exclusion criteria (9 listed)
- Women who do not speak or understand Danish
- Multiple pregnancy
- In active labour
- Previous sectio
- Maternal diseases (i.e. Diabetes, preeclampsia, heart diseases)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureAlso: Seirin Steel needles, and Park Sham needlesacupuncture in points bilaterally: BL 67, LI 4, SP6, one in GV20. | Device | 2, A |
Primary outcome
In active delivery or not (over or equal to 3 cm)
Time frame: 24 hrs
3 secondary outcomes
Degree of dilatation of orificium
Time frame: 24 hrs
Ruptured membranes or not,
Time frame: 24 hrs
Increase in uterine activity or not,
Time frame: 24 hrs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2009.
- Derived from this study: PubMed 20573151Modlock 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.
Related trials for Pregnancy Overdue - Week 41+6
RecruitingObservational study
The Combined First Trimester Screening
Preeclampsia (PE), Fetal Growth Restriction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels Uldbjerg, Professor principal investigator
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing acupuncture in people with Pregnancy Overdue - Week 41+6, run by Aarhus University Hospital Skejby.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In active delivery or not (over or equal to 3 cm) (time frame: 24 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00245752, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2009.