Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91106, France
NCT Number: NCT04128033
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.
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Female
Interventional
Not applicable
Corbeil-Essonnes, 91106, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Puncture of a placebo point "outside the meridian", with no effect
Time frame: immediately after childbirth
Rate of intact perineum after childbirth
Time frame: immediately after childbirth
lesion of the skin, vaginal mucosa, connective tissue, or sometimes the superficial muscle plane
Time frame: immediately after childbirth
Sphincter damage to the anus
Time frame: immediately after childbirth
Damage to the anal mucosa
Time frame: immediately after childbirth
Rate of episiotomies performed
Centre Hospitalier Sud Francilien
Other
Acronym: PELVIPUNCTURE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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