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Completed

NCT Number: NCT04128033

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Puncture of the RP6 point

Other

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

Other

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

Primary outcomes

  1. Rate of intact perineum after childbirth

    Time frame: immediately after childbirth

    Rate of intact perineum after childbirth

Secondary outcomes

  1. Rate of simple perineal tears

    Time frame: immediately after childbirth

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

  2. Rate of complete perineal tears

    Time frame: immediately after childbirth

    Sphincter damage to the anus

  3. Rate of complicated complete perineal tears

    Time frame: immediately after childbirth

    Damage to the anal mucosa

  4. Rate of episiotomies performed

    Time frame: immediately after childbirth

    Rate of episiotomies performed

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Sud Francilien

Other

Registry information

Acronym: PELVIPUNCTURE

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 16, 2019
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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