Visual biofeedback using transperineal ultrasound in second stage of labor.
Y Gilboa, T I Frenkel, Y Schlesinger...
https://pubmed.ncbi.nlm.nih.gov/29155474Actively Recruiting
Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
ID06049784
Prelabor Maternal Pushing Training Using Visual Biofeedback by a Self-operated Ultrasound Device
Led by Rabin Medical Center · Updated on 2024-05-06
261
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
R
Rabin Medical Center
Lead Sponsor
T
Tel Aviv University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness of visual biofeedback using a self-operated home ultrasound device for maternal pushing training before labor. The study focuses on pregnant women between 37 and 39 weeks of gestation to reduce fear of childbirth, increase control during birth, prevent prolonged labor and complications, and lessen post-traumatic stress symptoms. It builds on previous findings that intrapartum visual biofeedback during labor can improve pushing efficiency and maternal outcomes, expanding the approach to include home use before labor. Participants are randomly assigned to one of three groups: (1) visual biofeedback with both a hospital session and self-operated home ultrasound, (2) visual biofeedback with a single hospital ultrasound session, or (3) standard care with obstetrical ultrasound only. The intervention uses transperineal ultrasound to show the fetal head's descent during maternal pushing. The home ultrasound group receives a handheld device and training to perform biofeedback sessions at home, ideally twice weekly for up to four sessions. All groups undergo ultrasound assessments and complete questionnaires at baseline, about two weeks later, and six to eight weeks postpartum. During the study, participants will have fetal weight and biophysical profile scans at the hospital. They will complete self-report questionnaires and medical record reviews assessing labor duration, delivery mode, birth complications, fear of childbirth, post-traumatic stress symptoms, and mother-infant bonding. Participants using the home ultrasound send session data electronically for feedback. Follow-up includes interviews with some participants to explore their experiences. The primary outcome is the length of the second stage of labor, with secondary outcomes including delivery details, maternal psychological measures, and newborn health indicators. Total participation spans from pre-labor through six to eight weeks postpartum.
CONDITIONS
Brief Title
Prelabor Visual Biofeedback by a Self-operated Ultrasound Device
Who Can Participate
Age: 18Years +
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- First pregnancy (nulliparity)
- Singleton pregnancy
- Planned vaginal delivery
- Low risk pregnancy
- Ability to complete questionnaires
You will not qualify if you...
- Multiple pregnancies (multifetal gestation)
- Medical reasons preventing vaginal delivery (such as placenta previa or breech presentation)
- High risk pregnancy
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 2 weeks
Participants attend a single pre-labor training session at the hospital using ultrasound biofeedback to learn maternal pushing techniques, followed by a two-week self-administered home training using a handheld ultrasound device to continue visual biofeedback.
1 in-person hospital visit and home training sessions up to twice a week for 2 weeks
Follow-up
Duration - Up to 8 weeks postpartum
Participants complete questionnaires about obstetric and psychological outcomes before and after childbirth to assess the impact of the training intervention.
3 questionnaire time points: baseline, about 2 weeks later, and 6 to 8 weeks postpartum
Trial Site Locations
Total: 1 location
1
Rabin Medical Center
Petah Tikva, Israel
Actively Recruiting
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Research Team
S
Shira Waks
S
Sharon Perlman, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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Published Research Related To This Trial
Traditionally vs sonographically coached pushing in second stage of labor: a pilot randomized controlled trial.
F Bellussi, L Alcamisi, G Guizzardi...
https://pubmed.ncbi.nlm.nih.gov/29532533Mobile Self-Operated Home Ultrasound System for Remote Fetal Assessment During Pregnancy.
Eran Hadar, Leor Wolff, Kinneret Tenenbaum-Gavish...
https://pubmed.ncbi.nlm.nih.gov/33729014Preventing risk for posttraumatic stress following childbirth: Visual biofeedback during childbirth increases maternal connectedness to her newborn thereby preventing risk for posttraumatic stress following childbirth.
Yael Schlesinger, Daniel Hamiel, Sofie Rousseau...
https://pubmed.ncbi.nlm.nih.gov/32105133