PELVPUNCTURE: Impact of the Puncture of the RP6 Point on the Ampliation and Injuries of the Perineum During Childbirth
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: puncture of the RP6 point 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
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.
|
Placebo Comparator: puncture of the placebo point 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
Puncture of a placebo point "outside the meridian", with no effect
|
Outcome Measures
Primary Outcome Measures
- Rate of intact perineum after childbirth [immediately after childbirth]
Rate of intact perineum after childbirth
Secondary Outcome Measures
- Rate of simple perineal tears [immediately after childbirth]
lesion of the skin, vaginal mucosa, connective tissue, or sometimes the superficial muscle plane
- Rate of complete perineal tears [immediately after childbirth]
Sphincter damage to the anus
- Rate of complicated complete perineal tears [immediately after childbirth]
Damage to the anal mucosa
- Rate of episiotomies performed [immediately after childbirth]
Rate of episiotomies performed
Eligibility Criteria
Criteria
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:
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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
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patients with fetal death in utero
-
patients requiring medical termination of pregnancy
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Centre Hospitalier Sud Francilien | Corbeil-Essonnes | France | 91106 |
Sponsors and Collaborators
- Centre Hospitalier Sud Francilien
Investigators
- Study Director: Berangère BC CANON, MD, Centre Hospitalier Sud Francilien
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2018-A03070-55