Database of Monochorionic Pregnancies

Twin to Twin Transfusion Syndrome Clinical Trial

Official title:

Database: Standardized Prenatal Management and Perinatal Outcome of Complicated Monochorionic Pregnancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05543499
• Other study ID #: 20210709
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: December 1, 2027

Study information

• Verified date: April 2024
• Source: University of Miami
• Contact: Rodrigo Ruano, MD PhD
• Phone: (305) 585-5610
• Email: rodrigo.ruano[@]miami.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to collect and analyze data regarding natural history, indications for fetal interventions, and maternal and fetal/neonatal outcomes associated with complicated monochorionic twin pregnancy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 1, 2027
• Est. primary completion date: December 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• The study population will consist of MC pregnancies (maternal, fetal, and neonatal data) that have undergone evaluation and/or treatment for complications attributable to monochorionic twin pregnancy at the University of Miami.

• Maternal age 18 years and older.

Exclusion Criteria:

• Participation declined or consent not granted in prospective arm

• Loss to follow-up

Related Conditions & MeSH terms

• Fetofetal Transfusion
• Pregnancy Complications
• Syndrome
• Twin Reversal Arterial Perfusion Syndrome
• Twin to Twin Transfusion Syndrome
• Twin; Complicating Pregnancy

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Preterm Delivery	Preterm delivery is defined as birth <37 weeks gestation	Up to 42 weeks gestation
Primary	Number of participant with Premature Spontaneous Rupture of the Membranes	As per clinical evaluation	Up to 42 weeks
Primary	Number of Infant Deaths	The Number of Infant Deaths	Up to 12 months post infant delivery