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

Sponsor
Centre Hospitalier Sud Francilien (Other)
Overall Status
Completed
CT.gov ID
NCT04128033
Collaborator
(none)
350
1
2
5.8
59.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Puncture of the RP6 point
  • Other: Puncture of the placebo point
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
350 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Monocentric, randomized, simple blinded, controlled studyMonocentric, randomized, simple blinded, controlled study
Masking:
Single (Participant)
Masking Description:
Participant doesn't know if the point punctured is the experimental or the placebo point.
Primary Purpose:
Prevention
Official Title:
Impact of the Puncture of the RP6 Point on the Ampliation and Injuries of the Perineum During Childbirth
Actual Study Start Date :
Jan 4, 2019
Actual Primary Completion Date :
Jul 1, 2019
Actual Study Completion Date :
Jul 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Rate of intact perineum after childbirth [immediately after childbirth]

    Rate of intact perineum after childbirth

Secondary Outcome Measures

  1. Rate of simple perineal tears [immediately after childbirth]

    lesion of the skin, vaginal mucosa, connective tissue, or sometimes the superficial muscle plane

  2. Rate of complete perineal tears [immediately after childbirth]

    Sphincter damage to the anus

  3. Rate of complicated complete perineal tears [immediately after childbirth]

    Damage to the anal mucosa

  4. Rate of episiotomies performed [immediately after childbirth]

    Rate of episiotomies performed

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier Sud Francilien Corbeil-Essonnes France 91106

Sponsors and Collaborators

  • Centre Hospitalier Sud Francilien

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Sud Francilien
ClinicalTrials.gov Identifier:
NCT04128033
Other Study ID Numbers:
  • 2018-A03070-55
First Posted:
Oct 16, 2019
Last Update Posted:
Oct 16, 2019
Last Verified:
Oct 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Sud Francilien
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 16, 2019