Does Acupuncture Therapy Reduce the Need for Labor Induction After Postdate (Week 41)
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About
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.
Full description
To the study will be recruited women who have completed 40 weeks of pregnancy and have not yet given birth, with proper evaluation of mother and fetus.
Women who are fit to participate and had given their consent, will be computerized randomized to one of three groups.
Research groups:
- Group who receives acupuncture treatment in order to accelerate the development of birth.
- Group who receives sham treatment - non acupuncture treatment, but a similar treatment, so that the patient is unable to know whether she is receiving a real acupuncture treatment, or the similar one, which has no effect on the patient.
- Group who does not receive any treatment and will be reviewed a week later, unless a spontaneous birth will be developed. (Procedure accepted today) The study will be carried out between week 40 and week 41. During the week acupuncture treatment, sham treatment or conservative follow-up will be carried out, depending on the study group differentiation.
All women who will be randomized to the treatment groups, will fill a preliminary questionnaire for acupuncture treatment.
The course of treatment: During the week of study the women in the treatments groups will receive treatment every 48-72 hours, a maximum of three treatments.
Measures will be taken on the following week or two when the women will come to give birth.
Enrollment
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Inclusion criteria
- 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
Exclusion criteria
- Past Cesarean Section
- Women who have undergone acupuncture treatment during pregnancy
- Women who did not undergo separation membranes
Trial design
Primary purpose
Allocation
Interventional model
Masking
600 participants in 3 patient groups, including a placebo group
Trial contacts and locations
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Central trial contact
Liat Edry, PhD
Data sourced from clinicaltrials.gov
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