Clinical trial NCT04210908: Biofeedback for Second Stage of Labor
Official title: Ultrasound Imaging Biofeedback for Shortening the Second Stage of Labor: a Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Long
Labour;Obstructed
Keywords: Biofeedback
Second stage of labor
Operative delivery
Transperineal ultrasound
Lead sponsor: Assuta Ashdod Hospital
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label randomized control trial
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Duration of the second stage of labor
timeFrame: Up to 6 hours
Secondary outcomes:
measure: Mode of delivery
timeFrame: Up to 6 hours
measure: Neonatal 1 minute Apgar score
timeFrame: Up to 6 hours
measure: Neonatal 5 minute Apgar score
timeFrame: Up to 6 hours
measure: Cord pH
timeFrame: Up to 6 hours
measure: Postpartum hemorrhage
timeFrame: Up to 24 hours
measure: Maternal perineal tears
timeFrame: Up to 6 hours
Other outcomes:
Locations:
city: Ashdod
country: Israel
facility: Assuta Ashdod Hospital
Study officials:
affiliation: Samson Assuta Ashdod University Hospital
name: Eran Barzilay, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.