NCT06542744进行中（未招募）不适用
A Prospective, Multicentric, Randomized Clinical Investigation Assessing the Impact of Perineal Training With the Emagina Medical Device on Perineal Flexibility During Pregnancy and Childbirth
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mumming
- 入组人数
- 88
- 试验地点
- 30
- 主要终点
- Maximum diameter of balloon expelled at D90
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Maximum diameter of balloon expelled at D90
时间窗: 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
次要结局
- Subject's satisfaction during delivery(2 months after birth)
- Postnatal return to normal sexual activity(At baseline and 2 months postpartum)
- Weight of the baby at birth(At birth)
- Sex of the baby(At birth)
- APGAR score of the baby at birth(At Birth)
- Height of the baby at birth(At birth)
- Comparison of the expulsive phase(At Birth)
- Comparison of perineal injuries(At birth)
- Head size of the baby at birth(At birth)
- Quality of life (SF-12)(Baseline and 2 months after birth)
- Variation of pressure exerted by the perineum during the flexibility measurement(At Day 0 and Day 90 visits)
- Usability of the device(2 months after birth)
- Postnatal pelvic statics disorders(At baseline and 2 months postpartum)
- Postnatal urinary leakage(At baseline and 2 months postpartum)
- Postnatal perineal rehabilitation session(2 months after birth)
- Percentage of Compliance with the device(From baseline to birth)
- Adverse events(From baseline through study completion, an average of 6 months)
研究者
研究点 (30)
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