Biofeedback for Second Stage of Labor

Assuta Ashdod Hospital

Status: Completed

Conditions: Labour;Obstructed; Labor Long

Treatments: Other: Visual biofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT04210908

0064-19-AAA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Biofeedback

Experimental group

Description:

The patient will be instructed to bear down during 4 consecutive contractions while monitoring head descent using transperineal ultrasound. In the study group, patients will observe the descent of the head during contraction on the ultrasound display screen.

Treatment:

Other: Visual biofeedback

Control

No Intervention group

Description:

The patient will be instructed to bear down during 4 consecutive contractions while monitoring head descent using transperineal ultrasound. In the control group, patients will not observe the ultrasound display screen.