Pushing Using Real-time Sonographic Ultrasound Education (PURSUE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Change of duration of the second stage of labor
研究概览
简要总结
The study aims to assess whether the use of ultrasound during a pushing lesson can facilitate easier and safer childbirth. The research will be conducted at a single hospital and will involve pregnant women in their second trimester who enroll in an online childbirth course. Participants will be randomly assigned to one of two groups:
One group will receive standard pushing instructions from a midwife.
The other group will receive the same instructions along with a brief ultrasound session to visually support correct pushing techniques.
The primary outcome is a potential reduction in the duration of the second stage of labor (when the baby is being delivered). Secondary outcomes include improved coordination of pelvic floor muscles, fewer perineal tears, a higher rate of vaginal births, reduced postnatal urinary incontinence, and greater maternal satisfaction.
Approximately 136 women will be enrolled in the study (accounting for potential dropouts). The expectation is that this integrated teaching approach will enhance the effectiveness, safety, and overall experience of pushing during labor for both mothers and their newborns.
详细描述
This single-center, open-label, parallel-group randomized controlled trial aims to evaluate whether integrating transperineal ultrasound into a midwife-led pushing training program can reduce pelvic floor muscle coactivation during childbirth. Pregnant women in their second trimester, recruited from an online pre-childbirth course at Fondazione Policlinico Agostino Gemelli IRCCS, will be randomized to receive either standard midwife-led training or additional ultrasound-guided instruction. The primary outcome is the reduction in the duraction of the second stage of labour, with secondary outcomes including coactivation rates of pelvic floor muscles at delivery, maternal satisfaction, perineal tear rates, vaginal delivery rates, and postpartum urinary incontinence. With an estimated sample size of 136 participants accounting for a 15% dropout, the study anticipates that ultrasound-guided training will improve pushing efficiency, decrease pelvic trauma, and enhance delivery outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Nulliparous women in their second trimester (approximately 14-28 weeks of gestation).
- •Willingness to participate in the preparation training program on pushing techniques.
- •Singleton pregnancy.
- •Age 18 years or older.
- •Ability to understand and provide informed consent in Italian.
- •Plan to deliver at the Fondazione Policlinico Agostino Gemelli IRCCS.
排除标准
- •Multifetal (e.g., twins, triplets) pregnancies.
- •Known obstetric complications or conditions that contraindicate a vaginal delivery (e.g., placenta previa).
- •Medical or psychiatric conditions that would prevent participation in the educational program or adherence to study protocols.
- •History of pelvic floor surgery or severe pelvic floor dysfunction that might affect participation or outcomes.
- •Inability to understand study requirements or provide informed consent.
- •Participants already enrolled in conflicting clinical trials or interventions that could influence the study's outcomes.
研究组 & 干预措施
Midwife-led pushing training only group
The pushing training program consists of a two-hour in-person session, structured as follows:
- 30 minutes of theoretical instruction, covering the physiological mechanisms of labor, the role of the levator ani muscle (LAM) during pushing, and optimal pushing techniques.
- 30 minutes of practical exercises, during which women will be guided through breathing techniques, pushing strategies, and perineal relaxation.
干预措施: Midwife-led pushing training only group (Other)
Midwife-led ultrasound-guided pushing training group
The pushing training program consists of a two-hour in-person session, structured as follows:
- 30 minutes of theoretical instruction, covering the physiological mechanisms of labor, the role of the levator ani muscle (LAM) during pushing, and optimal pushing techniques.
- 30 minutes of practical exercises, during which women will be guided through breathing techniques, pushing strategies, and perineal relaxation.
Women randomized to the ultrasound-guided pushing training group will receive additional transperineal ultrasound (TPU) evaluations during practical exercises, performed by a midwife trained in ultrasound imaging. These assessments will ensure effective LAM relaxation during pushing practices and provide real-time visual feedback to optimize muscle coordination.
干预措施: Midwife-led ultrasound-guided pushing training group (Other)
结局指标
主要结局
Change of duration of the second stage of labor
时间窗: Measured from the onset of active labor until the moment of birth.
Change in duration (minuts) of the second stage of labor in the experimental arm compared with the control arm, defined as the elapsed time between complete cervical dilation and fetal expulsion.
次要结局
- Rate of perineal tears(Baseline)
- Levator ani muscle (LAM) coactivation rates(Measured from the onset of active labor until the moment of birth)
- Women's satisfaction(Measured after childbirth)
- Vaginal delivery rates(Baseline)
- Operative delivery rates(Baseline)
- Urinary incontinence rates(Measured at 6 and 12 weeks postpartum)
研究者
Anderson Gloria
Assistant Professor in Midwifery
Fondazione Policlinico Universitario Agostino Gemelli IRCCS