Post-term Pregnancy (40 to 42 Weeks Gestation) Clinical Trial
Official title:
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)
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.
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:
1. Group who receives acupuncture treatment in order to accelerate the development of
birth.
2. 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.
3. 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment