An interventional study of Visual biofeedback using transperineal ultrasound (TPUS) in Labor Stage, Second, sponsored by Kaplan Medical Center. Completed at 1 site in Israel. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-04.
Sponsored by Kaplan Medical Center · Not applicable, Interventional, and Other
The goal of this randomized controlled trial is to investigate whether using of coached sonographic pushing will decrease the length of the second stage of labor and the rate of operative deliveries.
Researchers will compare women who undergo the traditional coached pushing to women who undergo visual biofeedback coached pushing.
4,040 studies on the registry are indexed under Neoplasm Metastasis; 886 are open to participants now.
This study's enrollment of 324 is above the median of 50 across 3,268 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Kaplan Medical Center is the lead sponsor of 37 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study group, will have coached pushing using trans-perinal ultrasound (US) performed by the midwife during the active stage of labor, and after diagnosis of complete dilatation. Further, if not delivered within 2 hours of complete dilatation, a third coaching will be conducted. The coaching process in each will be performed for 10 minutes and for at least 3 contractions. In the study group the women will observe the fetal head movements on the screen in front of her.
Other: Visual biofeedback using transperineal ultrasound (TPUS)
The control group will have the traditional coached pushing (vaginal) performed by a midwide during the active stage of labor, and after diagnosis of complete dilatation. Further, if not delivered within 2 hours of complete dilatation, a third coaching will be conducted. The coaching process in each will be performed for 10 minutes and for at least 3 contractions The women in the controlled group will have the vocal coaching of the midwife during the contractions.
The intervention (study) arm will recieve coached maternal pushing via transperineal ultrasound (US) with visual biofeedback
Length of the second stage of labor
To investigate whether using of coached sonographic pushing will decrease the length of the second stage of labor.
Time frame: At baseline
Mode of delivery
To investigate whether using of coached sonographic pushing will affect the rate of operative deliveries.
Time frame: At baseline
Maternal outcomes
Maternal 3rd or 4th degree tear rate, postpartum hemorrhage rates
Time frame: At baseline
Neonatal Outcomes
Neonatal cord PH
Time frame: At baseline
Neonatal Outcomes
Apgar score less than 7 in 5 minutes.
Time frame: At baseline
Plan to share: Undecided
Ran from May 2021 to primary completion in May 2021, 0 months.
Of 291 non-industry interventional studies with no phase under Neoplasm Metastasis, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 93. This study's 0 months is below that.
Counting every sponsor, half of 316 studies reached it within 54 months; a quarter within 28 and three quarters within 91.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Kaplan Medical Center