NCT04128033

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: Centre Hospitalier Sud Francilien · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Perineum; Injury

Interventions

Type	Name	Description
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.
OTHER	Puncture of the placebo point	Puncture of a placebo point "outside the meridian", with no effect

Timeline

• Start date: 2019-01-04
• Primary completion: 2019-07-01
• Completion: 2019-07-01
• First posted: 2019-10-16
• Last updated: 2019-10-16

Locations

1 site across 1 country: France