Clinical trial NCT04128033: Impact of the Puncture of the RP6 Point on the Ampliation and Injuries of the Perineum During Childbirth
Official title: Impact of the Puncture of the RP6 Point on the Ampliation and Injuries of the Perineum During Childbirth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perineum; Injury
Keywords: acupuncture
perineum injury
delivery
Lead sponsor: Centre Hospitalier Sud Francilien
Sponsor class: OTHER
First posted: 2019-10-16
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Monocentric, randomized, simple blinded, controlled study
Primary purpose: PREVENTION

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.

Eligibility 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:

* 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

Primary outcomes:
measure: Rate of intact perineum after childbirth
timeFrame: immediately after childbirth
Secondary outcomes:
measure: Rate of simple perineal tears
timeFrame: immediately after childbirth
measure: Rate of complete perineal tears
timeFrame: immediately after childbirth
measure: Rate of complicated complete perineal tears
timeFrame: immediately after childbirth
measure: Rate of episiotomies performed
timeFrame: immediately after childbirth
Other outcomes:
Locations:
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
Study officials:
affiliation: Centre Hospitalier Sud Francilien
name: Berangère BC CANON, MD
role: STUDY_DIRECTOR
References: