Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06542744

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

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:

* 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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Pregnancy Childbirth

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ornella Ferrari, 1 Bis Rue Castéja, Boulogne-Billancourt, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Training with the Emagina device at home until birth

Device

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 intervention

Other

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

Primary outcomes

  1. Maximum diameter of balloon expelled at D90

    Time frame: Day 90

    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

Secondary outcomes

  1. Comparison of the expulsive phase

    Time frame: At Birth

    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

  2. Comparison of perineal injuries

    Time frame: At birth

    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

  3. APGAR score of the baby at birth

    Time frame: At Birth

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

  4. Height of the baby at birth

    Time frame: At birth

    Height measured in cm

  5. Weight of the baby at birth

    Time frame: At birth

    Weight measured in g

  6. Head size of the baby at birth

    Time frame: At birth

    Head circumference measured in cm

  7. Sex of the baby

    Time frame: At birth

    Gender of the baby determined at birth

  8. Quality of life (SF-12)

    Time frame: Baseline and 2 months after birth

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

  9. Subject's satisfaction during delivery

    Time frame: 2 months after birth

    Subject's satisfaction during delivery assessed by the QACE questionnaire

  10. Postnatal pelvic statics disorders

    Time frame: At baseline and 2 months postpartum

    Pelvic statics disorders assessed by the PFIQ-7 questionnaire

  11. Postnatal return to normal sexual activity

    Time frame: At baseline and 2 months postpartum

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

  12. Postnatal urinary leakage

    Time frame: At baseline and 2 months postpartum

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

  13. Postnatal perineal rehabilitation session

    Time frame: 2 months after birth

    Number of perineal rehabilitation session prescribed by investigator

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

    Time frame: At Day 0 and Day 90 visits

    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

  15. Usability of the device

    Time frame: 2 months after birth

    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)

  16. Percentage of Compliance with the device

    Time frame: From baseline to birth

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

  17. Adverse events

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

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

Sponsors and collaborators

Lead sponsor

Mumming

Industry

Registry information

Official study 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

Acronym: PeriFlex

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 7, 2024
Registry last updated
May 5, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.