Delivery Complication, Pregnancy Related
Conditions
Keywords
pre-labor education, biofeedback, ultrasound, vaginal delivery, fear of childbirth
Brief summary
The study will observe the effect of antenatal biofeedback with transperineal and abdominal ultrasound applied by a pelvic floor physical therapist. The training will focus on pelvic floor training and maternal-coached pushing with ultrasound-based visual biofeedback. The investigators aim to assess maternal and neonatal obstetrical outcomes, urinary and fecal incontinence, and maternal psychological effects.
Detailed description
Childbirth is a challenging process both emotionally and physically. The anxiety and anticipation accompanying pregnancy, labor, and delivery were reported to be relieved by pre-labor education, providing knowledge regarding the physiological process of labor to future parents. Ultrasound examination enables the laboring women the opportunity to see fetal head movements in response to maternal pushing, and previous studies have revealed the physiological and psychological advantages of ultrasound-mediated intrapartum biofeedback during the second stage of labor. Pre-labor sonographic maternal coaching has the advantage of a clean setting, avoiding the stressful, frequently hectic nature of labor and delivery wards, and may enable a more comprehensive implementation of the method, a structured training program, and better physical and psychological outcomes. All available literature regarding the application of intrapartum and pre-labor ultrasound refers to the examination performed by obstetricians. The study will observe the effect of antenatal biofeedback with transperineal and abdominal ultrasound applied by a pelvic floor physical therapist. The training will focus on two aspects: pelvic floor training and maternal coached pushing - both with ultrasound-based visual biofeedback. The investigators aim to assess maternal and neonatal obstetrical outcomes, urinary and fecal incontinence, and maternal psychological outcomes.
Interventions
BEHAVIORALPre-labor ultrasound as a visual biofeedback device for maternal pushing education and pelvic floor training
1. Ultrasound examination with the screen turned to the provider will assess the bladder movements at rest and during contraction of the pelvic floor and fetal head descent at rest and during pushing. 2. The provider will turn the screen to the patient and explain the anatomical landmarks: bladder, fetal head, birth canal direction. 3. A repeat of the first stage (1) with the screen turned to the patient: the biofeedback process. Bladder displacement will serve as a marker of pelvic floor contraction, and the delta in the progression angle will serve as a marker for effective pushing. 4. Finally, the provider will turn the screen again from the patient and repeat the first stage.
Sponsors
Ariel University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessor will collect the data from the files without knowing the participant's groups (intervention/control/standard care)
Intervention model description
Randomized controlled study
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* pregnant nullipara women with a low-risk pregnancy who are planned for vaginal delivery. The biofeedback will occur at 36-42 gestational weeks.
Exclusion criteria
* an inability to fill questionaries due to communication issues or cesarean section performed due to major obstetrical events.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| length of the second stage of labor | up to 1 week after labor | measure by time (min/hour) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mode of delivery | up to 1 week after labor | Number of Participants with spontaneous vaginal or operative delivery (operative assisted - vacuum-assisted, forceps assisted, cesarean delivery) |
| Perineal tears | up to 1 week after labor | Number of Participants with Perineal tears, specifically OASIS - obstetric anal sphincter Number of Participants with injuries |
| Urinary and fecal incontinence | up to 1 week after labor, and 2 month after labor. | Number of Participants with Urinary and/ or fecal incontinence |
| Fear of birth questionnaire | Baseline, a week later , 1 week after labor and two months after labor | 6-36, higher score mean worse outcome. |
Countries
Israel
Outcome results
None listed