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

NCT06782776 | Recruiting

• 1 other identifier: TWINS
• Study Type: observational
• Target: 6,600
• Locations: 1 country
• Sites: 1

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.

Conditions

Twin Pregnancy, Antepartum Condition or Complication

Keywords

Doppler echflowmetry

Outcome Measures

Primary Outcomes (1)

• Consequences of twinning on maternal and fetal hemodynamics

  Evaluation of the effects and consequences of twinning on maternal and fetal hemodynamics during pregnancy.

  up to 100 weeks

Secondary Outcomes (2)

• Potential risk factors for the development of adverse maternal or fetal outcomes

  up to 100 weeks

• Assessment of the presence of any different outcomes in relation to the guidelines applied in the past

  up to 100 weeks

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

Study Officials

• Gianluigi Pilu, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gianluigi Pilu, MD

CONTACT

0512143493; gianluigi.pilu@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: January 20, 2025
• Study Start: February 8, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 20, 2025

Record last verified: 2024-10

Locations

IT (1)