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

Not Applicable

Completed

• Conditions: Perineum; Injury
• Interventions: Other: Puncture of the RP6 point; Other: Puncture of the placebo point

• Registration Number: NCT04128033
• Lead Sponsor: Centre Hospitalier Sud Francilien

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.

Study Timeline

• Study Start: 2019-01-04
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-01
• Status Verified: 2019-10
• Study First Submitted: 2019-10-14
• Study First Submitted QC: 2019-10-15
• Last Update Submitted: 2019-10-15
• Study First Posted: 2019-10-16
• Last Update Posted: 2019-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 350

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
puncture of the RP6 point	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.
puncture of the placebo point	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.

Primary Outcome Measures

Name	Time	Method
Rate of intact perineum after childbirth	immediately after childbirth	Rate of intact perineum after childbirth

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre Hospitalier Sud Francilien; 🇫🇷 Corbeil-Essonnes, France