Labor Active Dilated CmNCT07278271
Decision-Making in Labor Admission Using Transperineal Ultrasound vs. Vaginal Examination
A study testing Transperineal Ultrasound and Vaginal Examination in people with Labor Active Dilated Cm, run by Hospital Universitario La Paz at 1 site in Spain.
Trial summary
This clinical trial aims to determine whether transperineal ultrasound (a perineal external scan) can improve decision-making for hospital admission in term pregnant women in labor compared to traditional vaginal examination. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Labor Active Dilated Cm
- What is being tested?
- Transperineal Ultrasound and Vaginal Examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteSpain
- Study dates
- 29 Jan 2024to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18 to 45 years
- Singleton pregnancy
- Gestational age ≥ 37 weeks (term pregnancy)
- Spontaneous uterine contractions at the time of presentation to the emergency department
- Cephalic presentation
- Willingness and ability to provide written informed consent
Who cannot join
- Premature rupture of membranes (PROM)
- Multiple gestation
- Known high-risk pregnancy (e.g., preeclampsia, intrauterine growth restriction, insulin-dependent diabetes)
- Previous cesarean delivery
- Breech or other non-cephalic presentation
- Elective cesarean section planned or requested
- Refusal to undergo vaginal delivery
- Inability or unwillingness to comply with the study protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario La Paz
Madrid, Madrid, 28046
Marcos Javier Cuerva González, PhD, 0034677026551, marcosj.cuerva@salud.madrid.org
Jose Luis Bartha Rasero, Prof. Dr. José Luis Bartha, MD, 0034917277008
About this study
Official title: Toma de Decisiones en la Admisión Hospitalaria al Parto Con Ecografía Transperineal vs. Tacto Vaginal: Estudio Aleatorizado Controlado
This clinical trial aims to determine whether transperineal ultrasound (a perineal external scan) can improve decision-making for hospital admission in term pregnant women in labor compared to traditional vaginal examination. Term pregnant women (>37 weeks) presenting with contractions at the emergency department will be randomly assigned to undergo either a transperineal ultrasound or a vaginal examination upon arrival. The study will evaluate whether ultrasound-based assessment reduces the rate of labor inductions and decreases patient discomfort during the admission evaluation. All participants will receive standard clinical evaluation and follow-up according to the assigned method, report discomfort levels using a standardized scale, and have labor outcomes recorded - including induction, oxytocin use, time to delivery, and mode of delivery -, to determine whether ultrasound improves clinical decision-making and maternal comfort.
Read the detailed description
This single-center, prospective, randomized controlled clinical trial is designed to evaluate whether transperineal ultrasound provides a more effective and less discomforting method than standard vaginal examination for decision-making regarding hospital admission in term pregnant women presenting with contractions. Vaginal examination remains the standard approach for assessing labor progression but is known to be subjective, poorly reproducible, and frequently uncomfortable for patients. In contrast, transperineal ultrasound offers objective and reproducible parameters such as cervical dilation, fetal head station, angle of progression, and head-perineum distance. Incorporating these measurements into the clinical evaluation may optimize admission criteria, reduce unnecessary hospitalizations, and lower the rate of labor inductions. After obtaining informed consent, eligible participants will be randomly assigned in a 1:1 ratio to either a transperineal ultrasound group or a standard vaginal examination group. In the ultrasound group, hospital admission will be recommended when cervical dilation is ≥3 cm or the angle of progression exceeds 120°, in the presence of regular uterine contractions. In the vaginal examination group, admission will be recommended when cervical dilation is ≥4 cm with regular contractions. Maternal discomfort during the evaluation will be assessed on a 0-10 numerical scale, and all labor outcomes and interventions will be recorded in standardized case report forms. A total of 170 participants (85 per group) will be enrolled to detect an 18% difference in labor induction rates with 80% power and a 95% confidence level. Statistical analyses will include descriptive and comparative methods (Chi-square, t-test, or non-parametric equivalents), with significance defined as p<0.05. The study will adhere to the principles of the Declaration of Helsinki and comply with applicable data protection regulations, including the Spanish Ley Orgánica de Protección de Datos (Organic Law on Data Protection, LOPD) and the European General Data Protection Regulation (GDPR).All participants will provide written informed consent prior to inclusion, and all data will be anonymized. The protocol has received approval from the institutional ethics committee. This trial builds upon prior observational findings demonstrating high agreement between ultrasound-based and traditional methods for assessing labor progression. By generating high-level evidence, it aims to support the implementation of transperineal ultrasound in labor triage protocols, improving the accuracy of clinical decision-making, enhancing maternal comfort, and contributing to better obstetric outcomes.
- Conditions
- Labor Active Dilated Cm
- Being tested
- Transperineal Ultrasound, Vaginal Examination
- Keywords
- Transperineal ultrasound, Intrapartum ultrasound, Vaginal examination, Hospital admission in labor, Term pregnancy, Angle of progression, Cervical dilatation, Ultrasound vs vaginal exam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transperineal UltrasoundDiagnostic test
Transperineal ultrasound will be performed to assess cervical dilatation, angle of progression, fetal head position, and head-perineum distance. Admission decisions will be made based on predefined sonographic thresholds.
Vaginal ExaminationDiagnostic test
Standard digital vaginal examination will be conducted to assess cervical dilatation. Admission decisions will follow institutional protocol (≥4 cm dilation with regular contractions).
| Study group | Role | What they receive |
|---|---|---|
| Transperineal Ultrasound | Experimental | Participants in this arm will undergo transperineal ultrasound to assess cervical dilatation, angle of progression (AOP), fetal head position, and head-perineum distance (HPD). Hospital admission will be based on predefined sonographic criteria (e.g., dilation ≥3 cm or angle of progression >120° plus regular uterine contractions). Receives: Diagnostic Test: Transperineal Ultrasound |
| Vaginal Examination | Active comparator | Participants in this arm will undergo standard digital vaginal examination. Hospital admission will be based on cervical dilation ≥4 cm and regular uterine contractions, following the routine clinical protocol. Receives: Diagnostic Test: Vaginal Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Labor Induction
Proportion of participants who undergo labor induction if admitted after evaluation by transperineal ultrasound or vaginal examination.
Measured: From hospital admission decision to delivery
Secondary outcomes (4)
Use of Oxytocin for Labor Augmentation
Proportion of participants who receive oxytocin for augmentation of labor following initial triage evaluation.
Measured: During labor (up to delivery)
Time from Admission to Delivery
Measured: From hospital admission to time of delivery
Mode of Delivery (as recorded in the medical record)
Mode of delivery will be recorded from the medical record and categorized as spontaneous vaginal delivery, assisted vaginal delivery (instrumental), or cesarean section.
Measured: At birth
Number of Vaginal Examinations Performed
Measured: From hospital admission for labor to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start29 Jan 2024
- Primary completionJan 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor Active Dilated CmStudies 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
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcos Javier Cuerva González, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278271
- Sponsor's protocol ID
- PI-4053
- Status last verified
- Dec 2025
- First submitted
- 7 May 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie the results reported in this study (after de-identification) will be made available to researchers upon reasonable request. This will include data on primary and secondary outcomes. Data will be shared after publication of the main results and with approval from the principal investigator and institutional ethics committee. Requests should be directed to Dr. Marcos J. Cuerva at marcosj.cuerva@salud.madrid.org
Publications
Cuerva MJ, Garcia-Casarrubios P, Garcia-Calvo L, Gutierrez-Simon M, Ordas P, Magdaleno F, Bartha JL; ITU-R12 Group. Use of intrapartum ultrasound in term pregnant women with contractions before hospital admission. Acta Obstet Gynecol Scand. 2019 Feb;98(2):162-166. doi: 10.1111/aogs.13474. Epub 2018 Oct 30.
PubMed 30288731
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toma de Decisiones en la Admisión Hospitalaria al Parto Con Ecografía Transperineal vs. Tacto Vaginal: Estudio Aleatorizado Controlado
- ClinicalTrials.gov ID
- NCT07278271
- Acronym / sponsor ID
- PI-4053
- Conditions
- Labor Active Dilated Cm
- Keywords
- Transperineal ultrasound, Intrapartum ultrasound, Vaginal examination, Hospital admission in labor, Term pregnancy, Angle of progression, Cervical dilatation, Ultrasound vs vaginal exam
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 12 Dec 2025 (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.
This clinical trial aims to determine whether transperineal ultrasound (a perineal external scan) can improve decision-making for hospital admission in term pregnant women in labor compared to traditional vaginal examination. Term pregnant women (>37 weeks) presenting with contractions at the emergency department will be randomly assigned to undergo either a transperineal ultrasound or a vaginal examination upon arrival. The study will evaluate whether ultrasound-based assessment reduces the rate of labor inductions and decreases patient discomfort during the admission evaluation. All participants will receive standard clinical evaluation and follow-up according to the assigned method, report discomfort levels using a standardized scale, and have labor outcomes recorded - including induction, oxytocin use, time to delivery, and mode of delivery -, to determine whether ultrasound improves clinical decision-making and maternal comfort.
Detailed description
This single-center, prospective, randomized controlled clinical trial is designed to evaluate whether transperineal ultrasound provides a more effective and less discomforting method than standard vaginal examination for decision-making regarding hospital admission in term pregnant women presenting with contractions. Vaginal examination remains the standard approach for assessing labor progression but is known to be subjective, poorly reproducible, and frequently uncomfortable for patients. In contrast, transperineal ultrasound offers objective and reproducible parameters such as cervical dilation, fetal head station, angle of progression, and head-perineum distance. Incorporating these measurements into the clinical evaluation may optimize admission criteria, reduce unnecessary hospitalizations, and lower the rate of labor inductions. After obtaining informed consent, eligible participants will be randomly assigned in a 1:1 ratio to either a transperineal ultrasound group or a standard vaginal examination group. In the ultrasound group, hospital admission will be recommended when cervical dilation is ≥3 cm or the angle of progression exceeds 120°, in the presence of regular uterine contractions. In the vaginal examination group, admission will be recommended when cervical dilation is ≥4 cm with regular contractions. Maternal discomfort during the evaluation will be assessed on a 0-10 numerical scale, and all labor outcomes and interventions will be recorded in standardized case report forms. A total of 170 participants (85 per group) will be enrolled to detect an 18% difference in labor induction rates with 80% power and a 95% confidence level. Statistical analyses will include descriptive and comparative methods (Chi-square, t-test, or non-parametric equivalents), with significance defined as p<0.05. The study will adhere to the principles of the Declaration of Helsinki and comply with applicable data protection regulations, including the Spanish Ley Orgánica de Protección de Datos (Organic Law on Data Protection, LOPD) and the European General Data Protection Regulation (GDPR).All participants will provide written informed consent prior to inclusion, and all data will be anonymized. The protocol has received approval from the institutional ethics committee. This trial builds upon prior observational findings demonstrating high agreement between ultrasound-based and traditional methods for assessing labor progression. By generating high-level evidence, it aims to support the implementation of transperineal ultrasound in labor triage protocols, improving the accuracy of clinical decision-making, enhancing maternal comfort, and contributing to better obstetric outcomes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transperineal Ultrasound | Experimental | Diagnostic Test: Transperineal UltrasoundParticipants in this arm will undergo transperineal ultrasound to assess cervical dilatation, angle of progression (AOP), fetal head position, and head-perineum distance (HPD). Hospital admission will be based on predefined sonographic criteria (e.g., dilation ≥3 cm or angle of progression >120° plus regular uterine contractions). |
| Vaginal Examination | Active comparator | Diagnostic Test: Vaginal ExaminationParticipants in this arm will undergo standard digital vaginal examination. Hospital admission will be based on cervical dilation ≥4 cm and regular uterine contractions, following the routine clinical protocol. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women aged 18 to 45 years
- Singleton pregnancy
- Gestational age ≥ 37 weeks (term pregnancy)
- Spontaneous uterine contractions at the time of presentation to the emergency department
- Cephalic presentation
Key exclusion criteria (8 listed)
- Premature rupture of membranes (PROM)
- Multiple gestation
- Known high-risk pregnancy (e.g., preeclampsia, intrauterine growth restriction, insulin-dependent diabetes)
- Previous cesarean delivery
- Breech or other non-cephalic presentation
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 |
|---|---|---|
| Transperineal UltrasoundTransperineal ultrasound will be performed to assess cervical dilatation, angle of progression, fetal head position, and head-perineum distance. Admission decisions will be made based on predefined sonographic thresholds. | Diagnostic test | Transperineal Ultrasound |
| Vaginal ExaminationStandard digital vaginal examination will be conducted to assess cervical dilatation. Admission decisions will follow institutional protocol (≥4 cm dilation with regular contractions). | Diagnostic test | Vaginal Examination |
Primary outcome
Rate of Labor Induction
Time frame: From hospital admission decision to delivery
Proportion of participants who undergo labor induction if admitted after evaluation by transperineal ultrasound or vaginal examination.
4 secondary outcomes
Use of Oxytocin for Labor Augmentation
Time frame: During labor (up to delivery)
Time from Admission to Delivery
Time frame: From hospital admission to time of delivery
Mode of Delivery (as recorded in the medical record)
Time frame: At birth
Number of Vaginal Examinations Performed
Time frame: From hospital admission for labor to delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Background: PubMed 30288731Cuerva MJ, Garcia-Casarrubios P, Garcia-Calvo L, Gutierrez-Simon M, Ordas P, Magdaleno F, Bartha JL; ITU-R12 Group. Use of intrapartum ultrasound in term pregnant women with contractions before hospital admission. Acta Obstet Gynecol Scand. 2019 Feb;98(2):162-166. doi: 10.1111/aogs.13474. Epub 2018 Oct 30.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie the results reported in this study (after de-identification) will be made available to researchers upon reasonable request. This will include data on primary and secondary outcomes. Data will be shared after publication of the main results and with approval from the principal investigator and institutional ethics committee. Requests should be directed to Dr. Marcos J. Cuerva at marcosj.cuerva@salud.madrid.org
Related trials for Labor Active Dilated Cm
Not yet recruitingObservational study
Comparison Between Using 10min CTG in Fetal Monitoring Instead of 30min Monitoring in Low Resources Overcrowded Hospitals.
Normal Pregnancy, Labor Active Dilated Cm
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transperineal Ultrasound and Vaginal Examination in people with Labor Active Dilated Cm, run by Hospital Universitario La Paz at 1 site in Spain.
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 8 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: looking for participants now, as of the sponsor's last update on 12 Dec 2025. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Labor Induction (time frame: From hospital admission decision to delivery). 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 NCT07278271, which also lists 1 linked publication.
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 12 Dec 2025.