Twin Pregnancy, Antepartum Condition or ComplicationTWINSNCT06782776
Role of Doppler Echoflowmetry to Define Risk Factors for the Development of Complications in Twin Pregnancies
An observational study of Twin Pregnancy, Antepartum Condition or Complication, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The goal of this observational study is to evaluate the outcomes of twin pregnancies referred to our center, in order to understand whether the use of different guidelines over time, with more systematic follow-up timing, has improved their management by reducing adverse events. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Twin Pregnancy, Antepartum Condition or Complication
- How many people
- 6,600 participants
- Where
- 1 siteItaly
- Study dates
- 8 Feb 2021to 31 Dec 2026
- Phase
- Observational
- 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 44 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population will consist of patients with twin pregnancies, regardless of chorionicity, who access the Pregnancy at Risk outpatient clinic at our center to perform the specific diagnostic care pathway.
Who may be able to join
- Age > 18 years
- Twin Pregnancy
- Ultrasound monitoring and delivery occurred at Policlinico S Orsola in Bologna, Italy
- Written informed consent form obtained from the patient
Who cannot join
- Completion of delivery at another facility
- Desire to undertake the Voluntary Interruption of Pregnancy
- Refusal to undergo instrumental monitoring and subsequent follow-up at our center
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Gianluigi Pilu, MD, 0512143493, gianluigi.pilu@aosp.bo.it
About this study
Official title: Retrospective and Prospective Study on the Role of Doppler Echoflowmetry in Defining Risk Factors for the Development of Complications in Twin Pregnancies
The goal of this observational study is to evaluate the outcomes of twin pregnancies referred to our center, in order to understand whether the use of different guidelines over time, with more systematic follow-up timing, has improved their management by reducing adverse events. All this would provide us with useful information for a better understanding of the effects of twinhood on pregnancy outcomes, so that we have more accurate information in counseling with patients.
Read the detailed description
The study is retrospective and prospective. Patients for whom twin pregnancy was monitored at the outpatient clinics of the division of Obstetrics and Prenatal Age Medicine, a regional referral center for the management of complicated pregnancies, will be enrolled.
Only those patients for whom the delivery was carried out at the same facility will be considered. This first phase will be necessary to obtain specific information about the complication rate and course of twin pregnancies that over the past 15 years (2005 to present) have been afferent at our facility. All patients will undergo the ultrasound evaluations required by the normal care protocols for twin pregnancies (biweekly checks if monochorionic or monthly if bicorionic) until 2026.
In addition to the standard ultrasound monitoring, an instrumental assessment will then be performed by means of the USCOM 1A ® technique, an ultrasound instrument that, by inputting the patient's height and weight, is able to calculate, thanks to internal algorithms, the diameter of the aortic valve and the blood flow through the valve itself. In addition, the peak pulsatility of the maternal ophthalmic artery will be assessed by Doppler ultrasound technique, which appears to be predictive of the risk of developing preeclampsia. In addition to the normal ultrasound evaluation provided by the current care procedure, an echocardiographic acquisition of the fetal heart by STRAIN technique will be performed.
Two-dimensional strain is based on the acquisition of a typical myocardial pattern (called finger print), which can be followed during the cardiac cycle. In other words, the software recognizes a small piece of tissue, evaluating its strain. Because of its angle-independence, two-dimensional strain allows global and segmental assessment of myocardial contractility, both longitudinal and radial. In these patients, strain would have the ability to detect a contractility deficit evidenced by a reduction in peak systolic strain and strain rate, which, as already demonstrated in adults, distinguishes areas of increased fibrosis, myocyte loss, and myocardial fiber reorganization. Strain may also be useful in prognostic stratification of heart failure, distinguishing fetuses with particularly impaired contractile capacity.
- Keywords
- Doppler echflowmetry
What is being measured
The primary outcome is the main question the study is designed to answer.
Consequences of twinning on maternal and fetal hemodynamics
Evaluation of the effects and consequences of twinning on maternal and fetal hemodynamics during pregnancy.
Measured: up to 100 weeks
Secondary outcomes (2)
Potential risk factors for the development of adverse maternal or fetal outcomes
Assessment of the presence of specific and potential risk factors for the development of adverse maternal or fetal outcomes
Measured: up to 100 weeks
Assessment of the presence of any different outcomes in relation to the guidelines applied in the past
Compare the guidelines applied in the past with the results obtained from the outcomes
Measured: up to 100 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start8 Feb 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Twin Pregnancy, Antepartum Condition or ComplicationStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 6,600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gianluigi Pilu, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782776
- Sponsor's protocol ID
- TWINS
- Acronym
- TWINS
- Status last verified
- Oct 2024
- First submitted
- 3 Dec 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective and Prospective Study on the Role of Doppler Echoflowmetry in Defining Risk Factors for the Development of Complications in Twin Pregnancies
- ClinicalTrials.gov ID
- NCT06782776
- Acronym / sponsor ID
- TWINS / TWINS
- Keywords
- Doppler echflowmetry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,600 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Jan 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.
The goal of this observational study is to evaluate the outcomes of twin pregnancies referred to our center, in order to understand whether the use of different guidelines over time, with more systematic follow-up timing, has improved their management by reducing adverse events. All this would provide us with useful information for a better understanding of the effects of twinhood on pregnancy outcomes, so that we have more accurate information in counseling with patients.
Detailed description
The study is retrospective and prospective. Patients for whom twin pregnancy was monitored at the outpatient clinics of the division of Obstetrics and Prenatal Age Medicine, a regional referral center for the management of complicated pregnancies, will be enrolled.
Only those patients for whom the delivery was carried out at the same facility will be considered. This first phase will be necessary to obtain specific information about the complication rate and course of twin pregnancies that over the past 15 years (2005 to present) have been afferent at our facility. All patients will undergo the ultrasound evaluations required by the normal care protocols for twin pregnancies (biweekly checks if monochorionic or monthly if bicorionic) until 2026.
In addition to the standard ultrasound monitoring, an instrumental assessment will then be performed by means of the USCOM 1A ® technique, an ultrasound instrument that, by inputting the patient's height and weight, is able to calculate, thanks to internal algorithms, the diameter of the aortic valve and the blood flow through the valve itself. In addition, the peak pulsatility of the maternal ophthalmic artery will be assessed by Doppler ultrasound technique, which appears to be predictive of the risk of developing preeclampsia. In addition to the normal ultrasound evaluation provided by the current care procedure, an echocardiographic acquisition of the fetal heart by STRAIN technique will be performed.
Two-dimensional strain is based on the acquisition of a typical myocardial pattern (called finger print), which can be followed during the cardiac cycle. In other words, the software recognizes a small piece of tissue, evaluating its strain. Because of its angle-independence, two-dimensional strain allows global and segmental assessment of myocardial contractility, both longitudinal and radial. In these patients, strain would have the ability to detect a contractility deficit evidenced by a reduction in peak systolic strain and strain rate, which, as already demonstrated in adults, distinguishes areas of increased fibrosis, myocyte loss, and myocardial fiber reorganization. Strain may also be useful in prognostic stratification of heart failure, distinguishing fetuses with particularly impaired contractile capacity.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population will consist of patients with twin pregnancies, regardless of chorionicity, who access the Pregnancy at Risk outpatient clinic at our center to perform the specific diagnostic care pathway.
Key inclusion criteria (4 listed)
- Age > 18 years
- Twin Pregnancy
- Ultrasound monitoring and delivery occurred at Policlinico S Orsola in Bologna, Italy
- Written informed consent form obtained from the patient
Key exclusion criteria (3 listed)
- Completion of delivery at another facility
- Desire to undertake the Voluntary Interruption of Pregnancy
- Refusal to undergo instrumental monitoring and subsequent follow-up at our center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Consequences of twinning on maternal and fetal hemodynamics
Time frame: up to 100 weeks
Evaluation of the effects and consequences of twinning on maternal and fetal hemodynamics during pregnancy.
2 secondary outcomes
Potential risk factors for the development of adverse maternal or fetal outcomes
Time frame: up to 100 weeks
Assessment of the presence of any different outcomes in relation to the guidelines applied in the past
Time frame: up to 100 weeks
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 20 Jan 2025.
Related trials for Twin Pregnancy, Antepartum Condition or Complication
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Twin Pregnancy, Antepartum Condition or Complication, Twin to Twin Transfusion as Antepartum Condition
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.
Gianluigi Pilu, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Twin Pregnancy, Antepartum Condition or Complication, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 3 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 20 Jan 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 Italy. 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?
Contact Gianluigi Pilu, MD (0512143493, gianluigi.pilu@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consequences of twinning on maternal and fetal hemodynamics (time frame: up to 100 weeks). 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 20 Jan 2025.