Labor LongNCT04210908
Biofeedback for Second Stage of Labor
A study testing Visual biofeedback in people with Labor Long and Labour;Obstructed, run by Assuta Ashdod Hospital at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Long, Labour;Obstructed
- What is being tested?
- Visual biofeedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 30 Apr 2020to 25 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- First labor
- Full dilation
- Head position between SP-1 and SP+2.
- Epidural anesthesia
- No contraindication for vaginal delivery
- Parturient informed consent
Who cannot join
- Participation in parallel studies.
- Category III fetal monitoring requiring immediate delivery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Imaging Biofeedback for Shortening the Second Stage of Labor: a Randomized Prospective Study
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.
Read the 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.
- Conditions
- Labor Long, Labour;Obstructed
- Being tested
- Visual biofeedback
- Keywords
- Biofeedback, Second stage of labor, Operative delivery, Transperineal ultrasound
- Medical subject headings
- Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual biofeedbackOther
Patient will observe the descent of the fetal head as they push during contractions
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback | Experimental | 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. Receives: Other: Visual biofeedback |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of the second stage of labor
Minutes from first documentation of full dilatation to delivery.
Measured: Up to 6 hours
Secondary outcomes (6)
Mode of delivery
Mode of delivery (categorical): spontaneous vaginal, operative vaginal or cesarean
Measured: Up to 6 hours
Neonatal 1 minute Apgar score
Apgar score at 1 minute after delivery (scale of 0-10)
Measured: Up to 6 hours
Neonatal 5 minute Apgar score
Apgar score at 5 minute after delivery (scale of 0-10)
Measured: Up to 6 hours
Cord pH
Umbilical cord blood pH
Measured: Up to 6 hours
Postpartum hemorrhage
Rate of early postpartum hemorrhage (during first 24 hours)
Measured: Up to 24 hours
Maternal perineal tears
Maternal perineal tear grade (categorical): None and grades 1-4
Measured: Up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start30 Apr 2020
- Primary completion19 Nov 2022
- Study completion25 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Labor LongStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label randomized control trial
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assuta Ashdod Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eran Brazilay, MD PhD, Assuta Ashdod Hospital
- Investigators
- Eran Barzilay, MD PhD, Principal investigator, Samson Assuta Ashdod University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210908
- Sponsor's protocol ID
- 0064-19-AAA
- Status last verified
- Nov 2022
- First submitted
- 15 Dec 2019
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19224527Gilboa 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.
PubMed 29155474Diegmann 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.
PubMed 10772737Levy 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.
PubMed 22605649
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Imaging Biofeedback for Shortening the Second Stage of Labor: a Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT04210908
- Acronym / sponsor ID
- 0064-19-AAA
- Conditions
- Labor Long, Labour;Obstructed
- Keywords
- Biofeedback, Second stage of labor, Operative delivery, Transperineal ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assuta Ashdod HospitalUniversity, hospital or other
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- 19 Nov 2022 (actual)
- Study completion
- 25 Nov 2022 (actual)
- First posted
- 26 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Biofeedback | Experimental | Other: Visual biofeedbackThe 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- First labor
- Full dilation
- Head position between SP-1 and SP+2.
- Epidural anesthesia
- No contraindication for vaginal delivery
Key exclusion criteria (2 listed)
- Participation in parallel studies.
- Category III fetal monitoring requiring immediate delivery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual biofeedbackPatient will observe the descent of the fetal head as they push during contractions | Other | Biofeedback |
Primary outcome
Duration of the second stage of labor
Time frame: Up to 6 hours
Minutes from first documentation of full dilatation to delivery.
6 secondary outcomes
Mode of delivery
Time frame: Up to 6 hours
Neonatal 1 minute Apgar score
Time frame: Up to 6 hours
Neonatal 5 minute Apgar score
Time frame: Up to 6 hours
Cord pH
Time frame: Up to 6 hours
Postpartum hemorrhage
Time frame: Up to 24 hours
Maternal perineal tears
Time frame: Up to 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Background: PubMed 19224527Kalache 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.
- Background: PubMed 29155474Gilboa 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.
- Background: PubMed 10772737Diegmann 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.
- Background: PubMed 22605649Levy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eran Barzilay, MD PhD principal investigator
Samson Assuta Ashdod University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual biofeedback in people with Labor Long and Labour;Obstructed, run by Assuta Ashdod Hospital at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of the second stage of labor (time frame: Up to 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04210908, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.