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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-04

Study Completion Date

2019-07-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Perineum; Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Monocentric, randomized, simple blinded, controlled study

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Participant doesn't know if the point punctured is the experimental or the placebo point.

Study Groups

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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.

Group Type EXPERIMENTAL

Puncture of the RP6 point

Intervention Type OTHER

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 the placebo point

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

Group Type PLACEBO_COMPARATOR

Puncture of the placebo point

Intervention Type OTHER

Puncture of a placebo point "outside the meridian", with no effect

Interventions

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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.

Intervention Type OTHER

Puncture of the placebo point

Puncture of a placebo point "outside the meridian", with no effect

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No