Perineum; Injury
Conditions
Keywords
acupuncture, perineum injury, delivery
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.
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.
Interventions
OTHERPuncture 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.
OTHERPuncture of the placebo point
Puncture of a placebo point "outside the meridian", with no effect
Sponsors
Centre Hospitalier Sud Francilien
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Participant doesn't know if the point punctured is the experimental or the placebo point.
Intervention model description
Monocentric, randomized, simple blinded, controlled study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of intact perineum after childbirth | immediately after childbirth | Rate of intact perineum after childbirth |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Contacts
STUDY_DIRECTORBerangère BC CANON, MD
Centre Hospitalier Sud Francilien
Outcome results
None listed