Labor Long, Labour;Obstructed
Conditions
Keywords
Biofeedback, Second stage of labor, Operative delivery, Transperineal ultrasound
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.
Interventions
OTHERVisual biofeedback
Patient will observe the descent of the fetal head as they push during contractions
Sponsors
Assuta Ashdod Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label randomized control trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of the second stage of labor | Up to 6 hours | Minutes from first documentation of full dilatation to delivery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal 1 minute Apgar score | Up to 6 hours | Apgar score at 1 minute after delivery (scale of 0-10) |
| Neonatal 5 minute Apgar score | Up to 6 hours | Apgar score at 5 minute after delivery (scale of 0-10) |
| Mode of delivery | Up to 6 hours | Mode of delivery (categorical): spontaneous vaginal, operative vaginal or cesarean |
| Postpartum hemorrhage | Up to 24 hours | Rate of early postpartum hemorrhage (during first 24 hours) |
| Maternal perineal tears | Up to 6 hours | Maternal perineal tear grade (categorical): None and grades 1-4 |
| Cord pH | Up to 6 hours | Umbilical cord blood pH |
Countries
Israel
Outcome results
None listed