Database of Monochorionic Pregnancies

NCT05543499 | Active Not Recruiting

• 1 other identifier: 20210709
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

multiple pregnancies; Twins

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Participation declined or consent not granted in prospective arm
• Loss to follow-up

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Pregnancy Complications; Fetofetal Transfusion

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Anemia, Neonatal; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Rodrigo Ruano, MD PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief of MFM Division

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 16, 2022
• Study Start: October 1, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)