Childbirth, Pregnancy
Conditions
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
Brief 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 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
Interventions
DEVICETraining with the Emagina device at home until birth
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.
OTHERNo intervention
The subjects will follow usual care instructions. Subjects are not trained in the use of Emagina.
Sponsors
Mumming
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum diameter of balloon expelled at D90 | 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
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the expulsive phase | 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 |
| Comparison of perineal injuries | 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 |
| APGAR score of the baby at birth | At Birth | APGAR score at 1 minute, 5 minutes and 10 minutes after birth |
| Height of the baby at birth | At birth | Height measured in cm |
| Weight of the baby at birth | At birth | Weight measured in g |
| Head size of the baby at birth | At birth | Head circumference measured in cm |
| Sex of the baby | At birth | Gender of the baby determined at birth |
| Quality of life (SF-12) | Baseline and 2 months after birth | Quality of life assessed by the SF-12 and lifestyle assessed by a short survey |
| Subject's satisfaction during delivery | 2 months after birth | Subject's satisfaction during delivery assessed by the QACE questionnaire |
| Postnatal pelvic statics disorders | At baseline and 2 months postpartum | Pelvic statics disorders assessed by the PFIQ-7 questionnaire |
| Postnatal return to normal sexual activity | 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), |
| Postnatal urinary leakage | At baseline and 2 months postpartum | the % of subjects with urinary leakage 2 months after delivery assessed by ICIQ-UI questionnaire |
| Postnatal perineal rehabilitation session | 2 months after birth | Number of perineal rehabilitation session prescribed by investigator |
| Variation of pressure exerted by the perineum during the flexibility measurement | 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 |
| Usability of the device | 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) |
| Percentage of Compliance with the device | 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 |
| Adverse events | 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORDavid Desseauve, MD
Centre Hospitalier Universitaire de Grenoble Alpes
Outcome results
None listed