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Clinical Trials/NCT05543499
NCT05543499
Active, not recruiting
Not Applicable

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

University of Miami1 site in 1 country1,200 target enrollmentOctober 1, 2022

Overview

Phase
Not Applicable
Intervention
Monochorionic Pregnancy Group
Conditions
Monochorionic Diamniotic Placenta
Sponsor
University of Miami
Enrollment
1200
Locations
1
Primary Endpoint
Number of participants with Preterm Delivery
Status
Active, not recruiting
Last Updated
2 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2022
End Date
December 1, 2027
Last Updated
2 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rodrigo Ruano

Professor and Chief of MFM Division

University of Miami

Eligibility Criteria

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

Arms & Interventions

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.

Outcomes

Primary Outcomes

Number of participants with Preterm Delivery

Time Frame: Up to 42 weeks gestation

Preterm delivery is defined as birth \<37 weeks gestation

Number of participant with Premature Spontaneous Rupture of the Membranes

Time Frame: Up to 42 weeks

As per clinical evaluation

Number of Infant Deaths

Time Frame: Up to 12 months post infant delivery

The Number of Infant Deaths

Study Sites (1)

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