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

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.

Study Overview

• Status: Completed
• Conditions: Perineum; Injury
• Intervention / Treatment: Other: Puncture of the RP6 point; Other: Puncture of the placebo point

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.

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Corbeil-Essonnes, France, 91106
    • Centre Hospitalier Sud Francilien

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Other: 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.
PLACEBO_COMPARATOR: 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.	Other: Puncture of the placebo point; Puncture of a placebo point "outside the meridian", with no effect

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of intact perineum after childbirth	Rate of intact perineum after childbirth	immediately after childbirth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of simple perineal tears	lesion of the skin, vaginal mucosa, connective tissue, or sometimes the superficial muscle plane	immediately after childbirth
Rate of complete perineal tears	Sphincter damage to the anus	immediately after childbirth
Rate of complicated complete perineal tears	Damage to the anal mucosa	immediately after childbirth
Rate of episiotomies performed	Rate of episiotomies performed	immediately after childbirth

Collaborators and Investigators

• Sponsor: Centre Hospitalier Sud Francilien
• Investigators: Study Director: Berangère BC CANON, MD, Centre Hospitalier Sud Francilien

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 4, 2019
• Primary Completion (ACTUAL): July 1, 2019
• Study Completion (ACTUAL): July 1, 2019

Study Registration Dates

• First Submitted: October 14, 2019
• First Submitted That Met QC Criteria: October 15, 2019
• First Posted (ACTUAL): October 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 16, 2019
• Last Update Submitted That Met QC Criteria: October 15, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: acupuncture; delivery; perineum injury
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 2018-A03070-55

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No