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

Perineum; Injury Clinical Trial

— PELVPUNCTURE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04128033
• Other study ID #: 2018-A03070-55
• Status: Completed
• Phase: N/A
• Start date: January 4, 2019
• Est. completion date: July 1, 2019

Study information

• Verified date: October 2019
• Source: Centre Hospitalier Sud Francilien
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Perineum; Injury
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Sud Francilien	Corbeil-Essonnes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Sud Francilien

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of intact perineum after childbirth	Rate of intact perineum after childbirth	immediately after childbirth
Secondary	Rate of simple perineal tears	lesion of the skin, vaginal mucosa, connective tissue, or sometimes the superficial muscle plane	immediately after childbirth
Secondary	Rate of complete perineal tears	Sphincter damage to the anus	immediately after childbirth
Secondary	Rate of complicated complete perineal tears	Damage to the anal mucosa	immediately after childbirth
Secondary	Rate of episiotomies performed	Rate of episiotomies performed	immediately after childbirth