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Brief Summary Short description of the protocol intended for the lay public. Include a brief statement of the study hypothesis. (Limit: 5000 characters)
Example: The purpose of this study is to determine whether prednisone, methotrexate, and cyclophosphamide are effective in the treatment of rapidly progressive hearing loss in both ears due to autoimmune inner ear disease (AIED). The first purpose of this randomized study is to determine if five points of acupuncture : 4GI, 6RP, 34VB, 36E, 3F could improve the bishop score for prolonged pregnancies and decrease the rate of maturation.
The protocol of our study consists of proposing to the pregnant women one or two acupuncture sessions the term's day and three days later. Once the consent is signed, women are randomly included in the experimental or placebo arm. In the experimental arm, midwives puncture five points : 4GI, 6 RP, 34VB, 36E, 3F on each side while in the placebo arm, they puncture just one point : 16 HM on each side.
The maturation's rate between the two groups will be compared by a Fisher's exact test and analyzed in function parity (nulliparous or multiparous) and number of sessions (one or two) with a model of univariate and multivariate logistic regression.
In maternity hospital center Corbeil-Essonnes, pregnant women have two monitoring consultations at term and three days later if they don't deliver between the two. At 41 weeks of amenorrhea and five days, women are convened in maternity for induction labour. Midwife determined Bishop's score with a vaginal exam to choose between a cervix's maturation (if bishop's score <5) or an induction of labour by oxytocin (if bishop's score>5).
The protocol of study consists of proposing to the pregnant women one or two acupuncture sessions the term's day and three days later. Once the consent is signed, women are randomly included in the experimental or placebo arm. In the experimental arm, midwives puncture five points : 4GI, 6 RP, 34VB, 36E, 3F on each side while in the placebo arm, they puncture just one point : 16 HM on each side.
At each consultation, the midwife collects the bishop's score to compare the average of it between the two arms and evaluate the rate of maturation.
The maturation's rate between the two groups will be compared by a Fisher's exact test and analyzed in function parity (nulliparous or multiparous) and number of sessions (one or two) with a model of univariate and multivariate logistic regression.
Finally, the average duration of induction labour will analyze, duration of labour and delivery route between the two arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental | In the experimental arm, pregnant women at term will benefit one or two acupuncture sessions with five points : 4GI, 6RP, 34VB,36E,3F. The first session at 41 amenorrhea weeks and the second at 41 amenorrhea weeks and 3 days if they are not delivered between the both. |
|
| Placebo acupuncture | Placebo Comparator | In the placebo arm, pregnant women will benefit one or two acupuncture sessions with one point which is located outside the acupuncture meridian. The first session at 41 amenorrhea weeks and the second at 41 amenorrhea weeks and 3 days if they are not delivered between the both. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Other | Puncture of 5 points 4GI, 6RP, 34VB, 36E, 3F |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Bishop score | cervix score is a pre-labor scoring system to assist in predicting whether induction of labor will be required (The highest possible score is 13 and the lowest possible score is 0) | At 41 weeks of amenorrhea |
| Bishop score | cervix score is a pre-labor scoring system to assist in predicting whether induction of labor will be required | 3 days after the term of pregnancy |
| Bishop score | cervix score is a pre-labor scoring system to assist in predicting whether induction of labor will be required | 5 days after the term of pregnancy |
| Measure | Description | Time Frame |
|---|---|---|
| Rate spontaneous labour | comparison of spontaneous labour's number in the two groups between 41 weeks of amenorrhea and 41 weeks of amenorrhea and five days. | At 41 weeks 5 days of amenorrhea |
| Duration labor |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Sud Francilien | Corbeil-Essonnes | 91106 | France |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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Women will be distributed randomly in the experimental or the placebo arm. They won't know that the point 16 HM isn't effective on cervix maturation. They will believe that both techniques work.
| Placebo Acupuncture |
| Other |
Puncture of point HM |
|
comparison of average number of hours between entry into the delivery room and the delivery, in the two groups.
| At 41 weeks 5 days of amenorrhea |
| Rate of delivery with medical intervention | comparison medical intervention's number in the two groups. | At 41 weeks 5 days of amenorrhea |
| Rate of delivery by cesarean | comparison cesarean's number in the two groups | At 41 weeks 5 days of amenorrhea |