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PregnancyPeriFlexNCT06542744

Comparison of the Flexibility of the Perineum in Primiparous Women Using the Medical Device Emagina During 90 Days of Their Pregnancy Compared to Those Having a Standard Pregnancy Follow-up

A study testing Training with the Emagina device at home until birth in people with Pregnancy and Childbirth, run by Mumming at 15 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this clinical investigation is to learn if training with Emagina device can improve flexibility of the perineum during childbirth with the help of a balloon that inflates in the genital area according to a time-limited exercise program specifically developed to optimize results, in adult, pregnant women… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Pregnancy, Childbirth
What is being tested?
Training with the Emagina device at home until birth
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
15 sitesFrance
Study dates
10 Oct 2024to 10 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Women over 18 years of age
  • Singleton (fetus)
  • Primiparous subject
  • Subject less than 5 months pregnant (between 20 and 24 week of amenorrhea)
  • Subject affiliated to a social security plan
  • Subject who has given written consent prior to any specific procedure related to the clinical investigation
  • Subject able to understand and complete the clinical investigation questionnaires
  • Subject having a smartphone and being able to download the Emagina app

Who cannot join

  • High-risk pregnancy (subjects presenting pregnancy-related risks will be excluded from participating in this clinical investigation, including risks of premature delivery, cases of symptomatically low-lying placenta and any contraindications to sexual relations)
  • Scheduled cesarean section prior to inclusion
  • History of vaginal or perineal surgery prior to pregnancy
  • Pelvic anomalies
  • Threatened preterm delivery prior to inclusion
  • Vaginismus
Show all 14Show fewer
  • Use of Epi-no prior to inclusion
  • Collagenosis or other chronic disorders affecting collagen
  • Planned home birth
  • Nerve damage and other illnesses that reduce sensitivity to pain in the genital area (i.e. paraplegia, multiple sclerosis, diabetic neuropathy, medication that alters sensitivity in the genital area, vulvar varicose veins).
  • Persons deprived of liberty, under guardianship or trusteeship
  • Drug or alcohol abuse
  • Dementia, mental impairment, or psychiatric pathology that may compromise subject informed consent and/or compliance with the protocol and trial monitoring
  • Subject unable to comply with protocol monitoring for psychological, social, family or geographic reasons

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

France15 sites

  • Ornella Ferrari, 1 Bis Rue Castéja

    Boulogne-Billancourt, 92100

  • Annabelle Sallandre, 7 Rue Ambroise Paré

    Coutances, 50200

  • Solène Baradu, 5 Rue des Sports

    Grandchamps-des-Fontaines, 44119

  • Grazia Sabatino, 2 impasse du Gaz

    Marseille, 13008

  • Jennifer Denys, 53 rue de la Méditerranée

    Montpellier, 34070

  • Elsa Molinier, 127 Rue Maurice Béjart

    Montpellier, 34080

  • Alexandra Sasportas, 8 Boulevard de Magenta

    Paris, 75010

  • Alice Rault, 103 Avenue de la République

    Paris, 75011

  • Marion Alglave, 8 Rue Ernest Renan

    Paris, 75015

  • Sobiha Sbai, 370 Avenue Jean Jaurès

    Ronchin, 59790

  • Tiphaine Cartier, 45 Boulevard des Belges

    Rouen, 76000

  • Céline Vauclin, 1 Avenue Jacques Chastellain

    Rouen, 76100

  • Ariane Gasulla, 43 Rue Camille Claudel

    Saint-Paul-lès-Dax, 40990

  • Annabel Buzy, 39 avenue Jean Jaurès

    Suresnes, 92150

  • Karen Methia, 15 Allée du Gros Chêne

    Verneuil-sur-Seine, 78480

Other trials in France

About this study

Official title: A Prospective, Multicentric, Randomized Clinical Investigation Assessing the Impact of Perineal Training With the Emagina Medical Device on Perineal Flexibility During Pregnancy and Childbirth

The goal of this clinical investigation is to learn if training with Emagina device can improve flexibility of the perineum during childbirth with the help of a balloon that inflates in the genital area according to a time-limited exercise program specifically developed to optimize results, in adult, pregnant women with their first child (single fetus) less than 24 weeks of amenorrhea at the time of inclusion (i.e. during the 5th month of pregnancy).

The main questions it aims to answer are:

Read more
  • Does the Emagina training program improve perineal flexibility during pregnancy ?
  • Does the Emagina training program reduce the proportion and importance of perineal tears, as well as the proportion of sutures and episiotomies during childbirth ?

Researchers will compare Emagina group to a Control group (no intervention) to see if Emagina device works to improve perineum flexibility.

Participants will :

  • measure the flexibility of their perineum on 2 occasions 90 days apart, with or without perineal training
  • perform perineal training with the Emagina medical device or follow current practice
  • fill out e-questionnaires regarding quality of life, lifestyle, pelvic static disorders, sexual activity and urinary incontinence
Being tested
Training with the Emagina device at home until birth, No intervention
Keywords
Pregnancy, Perineum, Perineal training, Perineal flexibility, Perineal trauma prevention, Pelvic floor disorder prevention, Delivery trauma, Episiotomies reduction, Perineal tearing prevention, Pelvic muscle injury, Vaginal delivery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Training with the Emagina device at home until birthDevice

    The subjects will use the device at home according to a series of 3 exercises, 2 sessions per week, followed by a series of 4 exercises, 3 sessions per week starting from D75.

  • No interventionOther

    The subjects will follow usual care instructions. Subjects are not trained in the use of Emagina.

Study groups in NCT06542744
Study groupRoleWhat they receive
Subjects using the Emagina Medical deviceExperimentalEmagina Medical device
Receives: Device: Training with the Emagina device at home until birth
Control groupOtherStandard of Care (SOC)
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum diameter of balloon expelled at D90

    To compare the flexibility of the perineum in primiparous subject having followed, during the pregnancy, the program of perineal training of the medical device Emagina during 90 days versus those having had a standard pregnancy follow-up

    Measured: Day 90

Secondary outcomes (17)

  1. Comparison of the expulsive phase

    Expulsive phase will be defined with: the duration of the expulsive phase, the % of instrumental extraction (forceps, spatulas or vacuum-assisted delivery), the % of epidural anesthesia

    Measured: At Birth

  2. Comparison of perineal injuries

    Perineal injuries will be defined with: the degree of perineal tears (according to the classification of perineal trauma), the % of grades 1, 2, 3, 4, the % of episiotomies, the % of perineal suture

    Measured: At birth

  3. APGAR score of the baby at birth

    APGAR score at 1 minute, 5 minutes and 10 minutes after birth

    Measured: At Birth

  4. Height of the baby at birth

    Height measured in cm

    Measured: At birth

  5. Weight of the baby at birth

    Weight measured in g

    Measured: At birth

  6. Head size of the baby at birth

    Head circumference measured in cm

    Measured: At birth

  7. Sex of the baby

    Gender of the baby determined at birth

    Measured: At birth

  8. Quality of life (SF-12)

    Quality of life assessed by the SF-12 and lifestyle assessed by a short survey

    Measured: Baseline and 2 months after birth

  9. Subject's satisfaction during delivery

    Subject's satisfaction during delivery assessed by the QACE questionnaire

    Measured: 2 months after birth

  10. Postnatal pelvic statics disorders

    Pelvic statics disorders assessed by the PFIQ-7 questionnaire

    Measured: At baseline and 2 months postpartum

  11. Postnatal return to normal sexual activity

    The % of subjects with return to normal sexual activity 2 months after delivery assessed by FSFI questionnaire (Yes/No),

    Measured: At baseline and 2 months postpartum

  12. Postnatal urinary leakage

    the % of subjects with urinary leakage 2 months after delivery assessed by ICIQ-UI questionnaire

    Measured: At baseline and 2 months postpartum

  13. Postnatal perineal rehabilitation session

    Number of perineal rehabilitation session prescribed by investigator

    Measured: 2 months after birth

  14. Variation of pressure exerted by the perineum during the flexibility measurement

    The variation of pressure exerted by the perineum during the flexibility measurement will be defined with following parameters: The pressure exerted while the balloon is fully inflated inside the vagina " IN ", The maximum pressure exerted during the expulsion of the balloon " EXP ", The pressure exerted when the balloon is outside " OUT ", Variation between IN and EXP defined as IN-EXP, Variation between EXP and OUT defined as EXP-OUT

    Measured: At Day 0 and Day 90 visits

  15. Usability of the device

    Usability of Emagina assessed by the subjects through a questionnaire developed by the sponsor (i.e. ease of use of Emagina device, absence of technical issues while using Emagina device)

    Measured: 2 months after birth

  16. Percentage of Compliance with the device

    Percentage of Compliance assessed by the Emagina App and defined as the number of days of use divided on the theoretical days of use

    Measured: From baseline to birth

  17. Adverse events

    Adverse events recorded from ICF (Informed Consent Form) signature until final visit including the rate of unscheduled cesarean sections

    Measured: From baseline through study completion, an average of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2024
  2. Study start10 Oct 2024
  3. Primary completion12 Dec 2025
  4. Study completion10 Oct 2026 (estimated)

Resources

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
Masking
None (open label)
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06542744
Sponsor's protocol ID
PeriFlex
Other IDs
2023-A01980-45
Acronym
PeriFlex
Status last verified
Apr 2026
First submitted
30 Jul 2024
Last updated
5 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Training with the Emagina device at home until birth in people with Pregnancy and Childbirth, run by Mumming at 15 sites 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 8 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 5 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 15 sites 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. 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?

This study is still under way. Results are not available in the source record yet.

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?

Maximum diameter of balloon expelled at D90 (time frame: Day 90). 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 NCT06542744.

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 5 May 2026.

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