Impact of the Puncture of the RP6 Point on the Ampliation and Injuries of the Perineum During Childbirth

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Impact of the Puncture of the RP6 Point on the Ampliation and Injuries of the Perineum During Childbirth

Conditions
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Perineum; Injury

Intervention / Treatment
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* Other: Puncture of the RP6 point
* Other: Puncture of the placebo point


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primiparous or multiparous women who have never given birth vaginally term patients (after 37 weeks of amenorrhea) patients delivering a fetus in cephalic presentation patients speaking and understanding French. Exclusion Criteria: patients suspected of having a fetal macrosomy (greater than the 97th percentile) on the last ultrasound patients with twin pregnancies excised patients patient who has made an acupuncture preparation during pregnancy patients with fetal death in utero patients requiring medical termination of pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Monocentric, randomized, simple blinded, controlled study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: puncture of the RP6 point<br>The acupuncturist midwife, who does not perform the delivery herself, punctures the RP6 point at the time of the expulsive efforts. | Other: Puncture of the RP6 point<br>* 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.<br>|
| Placebo Comparator: puncture of the placebo point<br>The acupuncturist midwife, who does not perform the delivery herself, punctures the placebo point at the time of the expulsive efforts. | Other: Puncture of the placebo point<br>* Puncture of a placebo point outside the meridian, with no effect<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of intact perineum after childbirth | Rate of intact perineum after childbirth | immediately after childbirth | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, perineum injury, delivery