Database of Monochorionic Pregnancies

Recruiting

• Conditions: Monochorionic Diamniotic Placenta; Monochorial Monoamniotic Placenta; Twin to Twin Transfusion Syndrome; Twin; Complicating Pregnancy; Twin Reversal Arterial Perfusion Syndrome

• Registration Number: NCT05543499
• Lead Sponsor: University of Miami

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-09-14
• Study First Posted: 2022-09-16
• Study Start: 2022-10-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-01
• Primary Completion: 2027-12-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with Preterm Delivery	Up to 42 weeks gestation	Preterm delivery is defined as birth \<37 weeks gestation
Number of participant with Premature Spontaneous Rupture of the Membranes	Up to 42 weeks	As per clinical evaluation
Number of Infant Deaths	Up to 12 months post infant delivery	The Number of Infant Deaths

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States