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| Name | Class |
|---|---|
| Clalit Health Services | OTHER |
| Reidman college | UNKNOWN |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group receives sham treatment | Placebo Comparator | Sham 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 | Experimental | The women in this group will receive acupuncture treatment every 48-72 hours, a maximum of three treatments. |
|
| Group doesn't receive any treatment | No Intervention | The women in this group will come for a follow-up check a week later, unless a spontaneous birth will develop. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture treatment | Other | acupuncture treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The number of women who received birth induction after week 41 | three weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liat Edry, PhD | Contact | 0508520296 | liatedry@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Tal Biron-Shental, MD | Meir Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meir Medial Center | Kfar Saba | Israel |
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| ID | Term |
|---|---|
| D011273 | Pregnancy, Prolonged |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Placebo Comparator |
| Other |
Placebo Comparator |
|
| three weeks |
| Hg before and after labour | three weeks |
| Number of women who received epidural | three weeks |
| Type of labour | three weeks |
| Apgar score after birth | three weeks |