Database of Monochorionic Pregnancies

Standardized Prenatal Management and Perinatal Outcome of Complicated Monochorionic Pregnancies

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Twin to Twin Transfusion Syndrome; Twin; Complicating Pregnancy; Twin Reversal Arterial Perfusion Syndrome; Monochorionic Diamniotic Placenta; Monochorial Monoamniotic Placenta

• Study Type: Observational
• Enrollment (Estimated): 1200

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of Monochorionic 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Monochorionic Pregnancy Group; Participants with complicated monochorionic pregnancies (MC) will be followed prospectively beginning at the time of the mother's evaluation for a complication related to monochorionic (MC) multiple pregnancies through delivery of the child and follow-up of the child to 12 months of life.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Rodrigo Ruano, MD PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: September 14, 2022
• First Submitted That Met QC Criteria: September 14, 2022
• First Posted (Actual): September 16, 2022

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: multiple pregnancies; Twins
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infant, Newborn, Diseases; Hematologic Diseases; Anemia; Anemia, Neonatal; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hemic and Lymphatic Diseases; Pregnancy Complications; Fetofetal Transfusion
• Other Study ID Numbers: 20210709

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No