AzTrials
AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
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.

Gianluigi Pilu, MD contact

0512143493

gianluigi.pilu@aosp.bo.it

Italy1 site, 1 recruiting
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Bologna, Bologna, 40138

    Gianluigi Pilu, MD, 0512143493, gianluigi.pilu@aosp.bo.it

    Recruiting

Other trials in Italy

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.

  1. 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)
  1. 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

  2. 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.

  1. First posted20 Jan 2025
  2. Study start8 Feb 2021
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in