Does Acupuncture Therapy Reduce the Need for Labor Induction After Postdate (Week 41)
Randomised ,Single Blind, Placebo Controlled in Meir Medical Center. Study the Potential of Acupuncture Therapy to Reduce the Need for Labor Induction After Postdate (Week 41)
1 other identifier
interventional
600
1 country
1
Brief Summary
In recent years, it is accepted to induce birth at week 41 in order to reduce the risk in surplus pregnancies. It was found that after 41 weeks, there is a significant increase in pregnancy complications including meconium liquor, shoulder dystocia and fetal death in uterus. Induction at 41 weeks was found to reduce the risk of complications described above, without taking the risk of cesarean section and, therefore, the recommendation of the Israel Society of Maternal Fetal Medicine, is to induce birth for women who completed 41 weeks of pregnancy. Induction is performed mechanically by entering a balloon to the cervix or by medicated prostaglandins and later, intravenous Pitocin to most women. The process takes two to three days with about 60-70% success rate. In recent years there has been a growing awareness to use natural methods to start labor. Many women tend to turn to natural medicine in order to reduce the need for conventional drugs to start labor. Given the lack of research on the issue and considering the rising demand of the involvement of alternative medicine in labor induction process, the investigators decided to carry out research on this subject.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2015
CompletedFirst Posted
Study publicly available on registry
March 19, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedMarch 19, 2015
February 1, 2015
2 years
March 2, 2015
March 18, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
The number of women who received birth induction after week 41
three weeks
Secondary Outcomes (7)
Number of women who had SROM (spontaneous rupture of membranes) or AROM (artificial rupture of membranes).
three weeks
Duration of labour
three weeks
Time past from treatment (acupuncture vs. placebo) till labour
three weeks
Hg before and after labour
three weeks
Number of women who received epidural
three weeks
- +2 more secondary outcomes
Study Arms (3)
Group receives sham treatment
PLACEBO COMPARATORSham treatment will be given on points on the back, points that are not acupuncture points, so that the patient will not be able to know whether she is receiving sham treatment or a real treatment. The treatment will be every 48-72 hours, a maximum of three treatments.
Group receives acupuncture treatment
EXPERIMENTALThe women in this group will receive acupuncture treatment every 48-72 hours, a maximum of three treatments.
Group doesn't receive any treatment
NO INTERVENTIONThe women in this group will come for a follow-up check a week later, unless a spontaneous birth will develop.
Interventions
Eligibility Criteria
You may qualify if:
- Women past their due date (week 40)
- Proper dating of pregnancy
- Uncomplicated pregnancy
- Normal evaluation as part of the mother and fetus routine examination on week 40
- Singleton pregnancy
- No contraindication for vaginal birth
- No significant signs of birth
You may not qualify if:
- Past Cesarean Section
- Women who have undergone acupuncture treatment during pregnancy
- Women who did not undergo separation membranes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Meir Medical Centerlead
- Clalit Health Servicescollaborator
- Reidman collegecollaborator
Study Sites (1)
Meir Medial Center
Kfar Saba, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tal Biron-Shental, MD
Meir Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2015
First Posted
March 19, 2015
Study Start
May 1, 2015
Primary Completion
May 1, 2017
Study Completion
May 1, 2018
Last Updated
March 19, 2015
Record last verified: 2015-02