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

Centre Hospitalier Sud Francilien

Status: Completed

Conditions: Perineum; Injury

Treatments: Other: Puncture of the RP6 point; Other: Puncture of the placebo point

Study type: Interventional

Funder types: Other

Identifiers

NCT04128033

2018-A03070-55

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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350 participants in 2 patient groups, including a placebo group

puncture of the RP6 point

Experimental group

Description:

The acupuncturist midwife, who does not perform the delivery herself, punctures the RP6 point at the time of the expulsive efforts.

Treatment:

Other: Puncture of the RP6 point

puncture of the placebo point

Placebo Comparator group

Description:

The acupuncturist midwife, who does not perform the delivery herself, punctures the placebo point at the time of the expulsive efforts.

Treatment:

Other: Puncture of the placebo point