Role of Doppler Echoflowmetry to Define Risk Factors for the Development of Complications in Twin Pregnancies

NCT ID: NCT06782776

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 6600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-08
• Study Completion Date: 2026-12-31

Brief 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. 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.

Conditions

Twin Pregnancy, Antepartum Condition or Complication

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gianluigi Pilu, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Gianluigi Pilu, MD

Role: CONTACT

gianluigi.pilu@aosp.bo.it

0512143493

Facility Contacts

Gianluigi Pilu, MD

Role: primary

gianluigi.pilu@aosp.bo.it

0512143493

Other Identifiers

TWINS

Identifier Type: -

Identifier Source: org_study_id