Perineum; InjuryPELVIPUNCTURENCT04128033
Impact of the Puncture of the RP6 Point on the Ampliation and Injuries of the Perineum During Childbirth
A study testing Puncture of the RP6 point in people with Perineum; Injury, run by Centre Hospitalier Sud Francilien at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perineum; Injury
- What is being tested?
- Puncture of the RP6 point
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jan 2019to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
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.
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.
Read the 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
- Being tested
- Puncture of the RP6 point, Puncture of the placebo point
- Keywords
- acupuncture, perineum injury, delivery
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Puncture of the RP6 pointOther
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 pointOther
Puncture of a placebo point "outside the meridian", with no effect
| Study group | Role | What they receive |
|---|---|---|
| puncture of the RP6 point | Experimental | The acupuncturist midwife, who does not perform the delivery herself, punctures the RP6 point at the time of the expulsive efforts. Receives: Other: Puncture of the RP6 point |
| puncture of the placebo point | Placebo comparator | The acupuncturist midwife, who does not perform the delivery herself, punctures the placebo point at the time of the expulsive efforts. Receives: Other: Puncture of the placebo point |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of intact perineum after childbirth
Rate of intact perineum after childbirth
Measured: immediately after childbirth
Secondary outcomes (4)
Rate of simple perineal tears
lesion of the skin, vaginal mucosa, connective tissue, or sometimes the superficial muscle plane
Measured: immediately after childbirth
Rate of complete perineal tears
Sphincter damage to the anus
Measured: immediately after childbirth
Rate of complicated complete perineal tears
Damage to the anal mucosa
Measured: immediately after childbirth
Rate of episiotomies performed
Rate of episiotomies performed
Measured: immediately after childbirth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start4 Jan 2019
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perineum; InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Monocentric, randomized, simple blinded, controlled study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Berangère BC CANON, MD, Study director, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128033
- Sponsor's protocol ID
- 2018-A03070-55
- Acronym
- PELVIPUNCTURE
- Status last verified
- May 2026
- First submitted
- 14 Oct 2019
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Coralie Lesport, Laurianne Lopez, Bérengère Canon, François-Xavier Laborne; Impact de la puncture du point sanyinjiao Rt6 sur l'ampliation et les lésions du périnée au cours de l'accouchement; Acupuncture & Moxibustion; Juillet-Décembre 2020; Volume 19. Numéro 2; 180.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Puncture of the RP6 Point on the Ampliation and Injuries of the Perineum During Childbirth
- ClinicalTrials.gov ID
- NCT04128033
- Acronym / sponsor ID
- PELVIPUNCTURE / 2018-A03070-55
- Conditions
- Perineum; Injury
- Keywords
- acupuncture, perineum injury, delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 16 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Monocentric, randomized, simple blinded, controlled study
| Arm | Type | Receives |
|---|---|---|
| puncture of the RP6 point | Experimental | Other: Puncture of the RP6 pointThe 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 | Placebo comparator | Other: Puncture of the placebo pointThe acupuncturist midwife, who does not perform the delivery herself, punctures the placebo point at the time of the expulsive efforts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Puncture of the RP6 pointPuncture 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 RP6 point |
| Puncture of the placebo pointPuncture of a placebo point "outside the meridian", with no effect | Other | puncture of the placebo point |
Primary outcome
Rate of intact perineum after childbirth
Time frame: immediately after childbirth
Rate of intact perineum after childbirth
4 secondary outcomes
Rate of simple perineal tears
Time frame: immediately after childbirth
Rate of complete perineal tears
Time frame: immediately after childbirth
Rate of complicated complete perineal tears
Time frame: immediately after childbirth
Rate of episiotomies performed
Time frame: immediately after childbirth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Results publicationCoralie Lesport, Laurianne Lopez, Bérengère Canon, François-Xavier Laborne; Impact de la puncture du point sanyinjiao Rt6 sur l'ampliation et les lésions du périnée au cours de l'accouchement; Acupuncture & Moxibustion; Juillet-Décembre 2020; Volume 19. Numéro 2; 180.
- reviewLink provided by the sponsor.
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RecruitingObservational study
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Perineum; Wound, Postoperative Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berangère BC CANON, MD study director
Centre Hospitalier Sud Francilien
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Puncture of the RP6 point in people with Perineum; Injury, run by Centre Hospitalier Sud Francilien at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of intact perineum after childbirth (time frame: immediately after childbirth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04128033, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.