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

Primary Purpose

Perineum; Injury

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Puncture of the RP6 point
Puncture of the placebo point
Sponsored by
Centre Hospitalier Sud Francilien
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Perineum; Injury focused on measuring acupuncture, perineum injury, delivery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Sud Francilien

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

puncture of the RP6 point

puncture of the placebo point

Arm Description

The acupuncturist midwife, who does not perform the delivery herself, punctures the RP6 point at the time of the expulsive efforts.

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

Outcomes

Primary Outcome Measures

Rate of intact perineum after childbirth
Rate of intact perineum after childbirth

Secondary Outcome Measures

Rate of simple perineal tears
lesion of the skin, vaginal mucosa, connective tissue, or sometimes the superficial muscle plane
Rate of complete perineal tears
Sphincter damage to the anus
Rate of complicated complete perineal tears
Damage to the anal mucosa
Rate of episiotomies performed
Rate of episiotomies performed

Full Information

First Posted
October 14, 2019
Last Updated
October 15, 2019
Sponsor
Centre Hospitalier Sud Francilien
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1. Study Identification

Unique Protocol Identification Number
NCT04128033
Brief Title
Impact of the Puncture of the RP6 Point on the Ampliation and Injuries of the Perineum During Childbirth
Acronym
PELVPUNCTURE
Official Title
Impact of the Puncture of the RP6 Point on the Ampliation and Injuries of the Perineum During Childbirth
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 4, 2019 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Sud Francilien

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perineum; Injury
Keywords
acupuncture, perineum injury, delivery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Monocentric, randomized, simple blinded, controlled study
Masking
Participant
Masking Description
Participant doesn't know if the point punctured is the experimental or the placebo point.
Allocation
Randomized
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
puncture of the RP6 point
Arm Type
Experimental
Arm Description
The acupuncturist midwife, who does not perform the delivery herself, punctures the RP6 point at the time of the expulsive efforts.
Arm Title
puncture of the placebo point
Arm Type
Placebo Comparator
Arm Description
The acupuncturist midwife, who does not perform the delivery herself, punctures the placebo point at the time of the expulsive efforts.
Intervention Type
Other
Intervention Name(s)
Puncture of the RP6 point
Intervention Description
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
Intervention Name(s)
Puncture of the placebo point
Intervention Description
Puncture of a placebo point "outside the meridian", with no effect
Primary Outcome Measure Information:
Title
Rate of intact perineum after childbirth
Description
Rate of intact perineum after childbirth
Time Frame
immediately after childbirth
Secondary Outcome Measure Information:
Title
Rate of simple perineal tears
Description
lesion of the skin, vaginal mucosa, connective tissue, or sometimes the superficial muscle plane
Time Frame
immediately after childbirth
Title
Rate of complete perineal tears
Description
Sphincter damage to the anus
Time Frame
immediately after childbirth
Title
Rate of complicated complete perineal tears
Description
Damage to the anal mucosa
Time Frame
immediately after childbirth
Title
Rate of episiotomies performed
Description
Rate of episiotomies performed
Time Frame
immediately after childbirth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berangère BC CANON, MD
Organizational Affiliation
Centre Hospitalier Sud Francilien
Official's Role
Study Director
Facility Information:
Facility Name
Centre Hospitalier Sud Francilien
City
Corbeil-Essonnes
ZIP/Postal Code
91106
Country
France

12. IPD Sharing Statement

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

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