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

NCT04128033 | Completed DMC

• 1 other identifier: 2018-A03070-55
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Perineum; Injury

Keywords

acupuncture; perineum injury; delivery

Outcome Measures

Primary Outcomes (1)

• Rate of intact perineum after childbirth

  Rate of intact perineum after childbirth

  immediately after childbirth

Secondary Outcomes (4)

• Rate of simple perineal tears

  immediately after childbirth

• Rate of complete perineal tears

  immediately after childbirth

• Rate of complicated complete perineal tears

  immediately after childbirth

• Rate of episiotomies performed

  immediately after childbirth

Study Arms (2)

puncture of the RP6 point

EXPERIMENTAL

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 the placebo point

PLACEBO COMPARATOR

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

Interventions

Puncture of the RP6 point 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 RP6 point

Puncture of the placebo point OTHER

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

puncture of the placebo point

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Sud Francilien: lead

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Berangère BC CANON, MD

  Centre Hospitalier Sud Francilien

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant doesn't know if the point punctured is the experimental or the placebo point.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monocentric, randomized, simple blinded, controlled study

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 16, 2019
• Study Start: January 4, 2019
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: October 16, 2019

Record last verified: 2019-10

Locations

FR (1)