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During the study period, any patient who enters labour and reports to the maternity ward and meets the inclusion and non-inclusion criteria is offered to participate in the study by the midwife acupuncturist present.
After signing the informed consent, a numbered envelope with the randomization arm is assigned to the patient. The acupuncturist midwife does not perform the delivery herself. At the time of the expulsive efforts, she punctures the point drawn at random. The patient's participation in the study ends when she leaves the labour room after the birth.
During the study period, any patient who enters labour and reports to the maternity ward and meets the inclusion and non-inclusion criteria is offered to participate in the study by the midwife acupuncturist present. She's responsible for explaining the purpose and practicalities of the study orally and issues a written information document. The information provided is the same regardless of the midwife present. If she agrees to participate in the study, the patient signs the consent form.
After signing the informed consent, a numbered envelope with the randomization arm is assigned to the patient. The acupuncturist midwife does not perform the delivery herself. At the time of the expulsive efforts, she punctures the point drawn at random. She collects the clinical Research Form from the time the patient signs the consent form until she leaves the labour room after the birth.
The patient's participation in the study ends when she leaves the labour room after the birth. No further follow-up is planned.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| puncture of the RP6 point | Experimental | The acupuncturist midwife, who does not perform the delivery herself, punctures the RP6 point at the time of the expulsive efforts. |
|
| puncture of the placebo point | Placebo Comparator | The acupuncturist midwife, who does not perform the delivery herself, punctures the placebo point at the time of the expulsive efforts. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Puncture of the RP6 point | Other | Puncture of RP6 "San Yin Jiao" point, located just behind the posterior edge of the tibia 3 cm above the end of the inner malleolus. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of intact perineum after childbirth | Rate of intact perineum after childbirth | immediately after childbirth |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of simple perineal tears | lesion of the skin, vaginal mucosa, connective tissue, or sometimes the superficial muscle plane | immediately after childbirth |
| Rate of complete perineal tears | Sphincter damage to the anus |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Berangère BC CANON, MD | Centre Hospitalier Sud Francilien | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Sud Francilien | Corbeil-Essonnes | 91106 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Coralie Lesport, Laurianne Lopez, Bérengère Canon, François-Xavier Laborne; Impact de la puncture du point sanyinjiao Rt6 sur l'ampliation et les lésions du périnée au cours de l'accouchement; Acupuncture & Moxibustion; Juillet-Décembre 2020; Volume 19. Numéro 2; 180. |
| Label | URL |
|---|---|
| review | View source |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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Monocentric, randomized, simple blinded, controlled study
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Participant doesn't know if the point punctured is the experimental or the placebo point.
| Puncture of the placebo point | Other | Puncture of a placebo point "outside the meridian", with no effect |
|
| immediately after childbirth |
| Rate of complicated complete perineal tears | Damage to the anal mucosa | immediately after childbirth |
| Rate of episiotomies performed | Rate of episiotomies performed | immediately after childbirth |