Biofeedback for Second Stage of Labor

Labor Long Clinical Trial

Official title:

Ultrasound Imaging Biofeedback for Shortening the Second Stage of Labor: a Randomized Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04210908
• Other study ID #: 0064-19-AAA
• Status: Completed
• Phase: N/A
• Start date: April 30, 2020
• Est. completion date: November 25, 2022

Study information

• Verified date: November 2022
• Source: Assuta Ashdod Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine whether transperineal ultrasound as visual biofeedback can be used during labor as an effective tool for shortening the second stage of labor and reducing the need for instrumental delivery, in a prospective randomized design.

Description:

Biofeedback provides patients with better control of their body and their physiological reactions respective of the examined process, such as stress/anxiety, sports activity, labor, etc.

Women under epidural anesthesia, may frequently feel lack of control over the birthing process and difficulty in bearing down effectively, which is a very significant part of the second stage of labor.

Transperineal ultrasound during labor is a standard procedure in many medical centers in the world, mainly used to assist obstetricians in evaluating the progress of labor, fetal head position and assessing the chances of successful operative delivery. One of the most common tools used in transperineal ultrasound in measurement of the angle of progression, which has been suggested as a subjective method for assessing fetal station and for predicting successful vaginal delivery. A preliminary non-randomized study raised the possibility that the use of transperineal ultrasound during labor as a biofeedback tool may shorten the second stage of labor.

The purpose of this study is to examine whether this tool can be used during labor as an effective tool for shortening the second stage of labor and reducing the need for instrumental delivery, in a prospective randomized design.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 25, 2022
• Est. primary completion date: November 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. First labor

2. Full dilation

3. Head position between SP-1 and SP+2.

4. Epidural anesthesia

5. No contraindication for vaginal delivery

6. Parturient informed consent

Exclusion Criteria:

1. Participation in parallel studies.

2. Category III fetal monitoring requiring immediate delivery.

Related Conditions & MeSH terms

• Dystocia
• Labor Long
• Labour;Obstructed

Intervention

Other:
• Visual biofeedback
Patient will observe the descent of the fetal head as they push during contractions

Locations

Country	Name	City	State
Israel	Assuta Ashdod Hospital	Ashdod

Sponsors (1)

Lead Sponsor	Collaborator
Assuta Ashdod Hospital

Country where clinical trial is conducted

Israel, 

References & Publications (4)

Diegmann EK, Andrews CM, Niemczura CA. The length of the second stage of labor in uncomplicated, nulliparous African American and Puerto Rican women. J Midwifery Womens Health. 2000 Jan-Feb;45(1):67-71. doi: 10.1016/s1526-9523(99)00019-7. — View Citation

Gilboa Y, Frenkel TI, Schlesinger Y, Rousseau S, Hamiel D, Achiron R, Perlman S. Visual biofeedback using transperineal ultrasound in second stage of labor. Ultrasound Obstet Gynecol. 2018 Jul;52(1):91-96. doi: 10.1002/uog.18962. Epub 2018 May 29. — View Citation

Kalache KD, Duckelmann AM, Michaelis SA, Lange J, Cichon G, Dudenhausen JW. Transperineal ultrasound imaging in prolonged second stage of labor with occipitoanterior presenting fetuses: how well does the 'angle of progression' predict the mode of delivery? Ultrasound Obstet Gynecol. 2009 Mar;33(3):326-30. doi: 10.1002/uog.6294. — View Citation

Levy R, Zaks S, Ben-Arie A, Perlman S, Hagay Z, Vaisbuch E. Can angle of progression in pregnant women before onset of labor predict mode of delivery? Ultrasound Obstet Gynecol. 2012 Sep;40(3):332-7. doi: 10.1002/uog.11195. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of the second stage of labor	Minutes from first documentation of full dilatation to delivery.	Up to 6 hours
Secondary	Mode of delivery	Mode of delivery (categorical): spontaneous vaginal, operative vaginal or cesarean	Up to 6 hours
Secondary	Neonatal 1 minute Apgar score	Apgar score at 1 minute after delivery (scale of 0-10)	Up to 6 hours
Secondary	Neonatal 5 minute Apgar score	Apgar score at 5 minute after delivery (scale of 0-10)	Up to 6 hours
Secondary	Cord pH	Umbilical cord blood pH	Up to 6 hours
Secondary	Postpartum hemorrhage	Rate of early postpartum hemorrhage (during first 24 hours)	Up to 24 hours
Secondary	Maternal perineal tears	Maternal perineal tear grade (categorical): None and grades 1-4	Up to 6 hours