Obstetric Labor ComplicationsNCT02899481
Role of Intrapartum Ultrasound in Instrumental Delivery
A study testing Transabdominal and transperineal ultrasound in people with Obstetric Labor Complications, run by University of Lisbon at 1 site in Portugal.
Trial summary
Investigators will perform a multicentric randomized controlled trial comparing the effect of transabdominal and transperineal ultrasound in pregnant women in the second stage of labor, in whom it was decided an operative delivery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obstetric Labor Complications
- What is being tested?
- Transabdominal and transperineal ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 sitePortugal
- Study dates
- Sep 2016to Mar 2019
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pregnant women at term, in labor (≥ 37 weeks of gestation dated by a first trimester ultrasound
- live singleton pregnancy
- fetus in a cephalic presentation
- in the second stage of labor, after the decision to perform an instrumental delivery
Who cannot join
- fetal malformations
- emergency situation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Intrapartum Ultrasound in the Efficacy of an Instrumental Delivery
Investigators will perform a multicentric randomized controlled trial comparing the effect of transabdominal and transperineal ultrasound in pregnant women in the second stage of labor, in whom it was decided an operative delivery. Our objective is to evaluate the impact of intrapartal ultrasound measurements, as an auxiliary to clinical evaluation, in the efficacy of an instrumental delivery.
- Conditions
- Obstetric Labor Complications
- Being tested
- Transabdominal and transperineal ultrasound
- Medical subject headings
- Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transabdominal and transperineal ultrasoundOther
Transabdominal ultrasound, for determining fetal head position, is performed with the pregnant women in supine position after bladder emptying, with the transducer placed transversely on the suprapubic region of the maternal abdomen. For the sonographic determination of the fetal descent we will perform a transperineal ultrasound achieved by placing the ultrasound transducer on the perineum in a mid sagittal position between the labia below the pubic symphysis.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | The study group will be constituted by pregnant women in whom the operative delivery will be preceded by a transabdominal and transperineal ultrasound to evaluate fetal head position and fetal head station, by means of determination of the 'angle of progression'. Receives: Other: Transabdominal and transperineal ultrasound |
| Control group | No intervention | The control group will be constituted by pregnant women in whom the operative delivery will be carried out based solely on clinical criteria, namely transvaginal digital examination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal and neonatal morbidity
Severe postpartum hemorrhage, perineal trauma, prolonged hospital stay
Measured: 2 years
Neonatal morbidity
low 5-minute Apgar score, umbilical artery metabolic acidosis, birth trauma and neonatal intensive care unit admission
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2019
- Study completionMar 2019
Why it stopped: Data Safety Monitoring Committee recommended stopping the trial due to futility.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric Labor ComplicationsStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lisbon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joana Barros, University of Lisbon
- Investigators
- Joana Barros, MD, Principal investigator, University of Lisbon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899481
- Sponsor's protocol ID
- CC-157
- Status last verified
- Jun 2020
- First submitted
- 6 Jul 2016
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Intrapartum Ultrasound in the Efficacy of an Instrumental Delivery
- ClinicalTrials.gov ID
- NCT02899481
- Acronym / sponsor ID
- CC-157
- Conditions
- Obstetric Labor Complications
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Data Safety Monitoring Committee recommended stopping the trial due to futility.
- Enrolment
- 222 participants (actual)
- Lead sponsor
- University of LisbonUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 14 Sep 2016 (estimated)
- 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.
Investigators will perform a multicentric randomized controlled trial comparing the effect of transabdominal and transperineal ultrasound in pregnant women in the second stage of labor, in whom it was decided an operative delivery. Our objective is to evaluate the impact of intrapartal ultrasound measurements, as an auxiliary to clinical evaluation, in the efficacy of an instrumental delivery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Transabdominal and transperineal ultrasoundThe study group will be constituted by pregnant women in whom the operative delivery will be preceded by a transabdominal and transperineal ultrasound to evaluate fetal head position and fetal head station, by means of determination of the 'angle of progression'. |
| Control group | No intervention | –The control group will be constituted by pregnant women in whom the operative delivery will be carried out based solely on clinical criteria, namely transvaginal digital examination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- pregnant women at term, in labor (≥ 37 weeks of gestation dated by a first trimester ultrasound
- live singleton pregnancy
- fetus in a cephalic presentation
- in the second stage of labor, after the decision to perform an instrumental delivery
Key exclusion criteria (2 listed)
- fetal malformations
- emergency situation
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 |
|---|---|---|
| Transabdominal and transperineal ultrasoundTransabdominal ultrasound, for determining fetal head position, is performed with the pregnant women in supine position after bladder emptying, with the transducer placed transversely on the suprapubic region of the maternal abdomen. For the sonographic determination of the fetal descent we will perform a transperineal ultrasound achieved by placing the ultrasound transducer on the perineum in a mid sagittal position between the labia below the pubic symphysis. | Other | Study group |
Primary outcome
Maternal and neonatal morbidity
Time frame: 2 years
Severe postpartum hemorrhage, perineal trauma, prolonged hospital stay
Neonatal morbidity
Time frame: 2 years
low 5-minute Apgar score, umbilical artery metabolic acidosis, birth trauma and neonatal intensive care unit admission
Results and safety
The study was stopped early (reason given: Data Safety Monitoring Committee recommended stopping the trial due to futility.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- 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.
Joana Barros, MD principal investigator
University of Lisbon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transabdominal and transperineal ultrasound in people with Obstetric Labor Complications, run by University of Lisbon at 1 site in Portugal.
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 4 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: stopped early, as of the sponsor's last update on 23 Jun 2020. 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 Portugal. 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 was stopped early (reason given: Data Safety Monitoring Committee recommended stopping the trial due to futility.). Results are not available in the source record.
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?
Maternal and neonatal morbidity (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2020.