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Database of Monochorionic Pregnancies

Sponsor
University of Miami (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05543499
Collaborator
(none)
1,200
Enrollment
1
Location
60
Anticipated Duration (Months)
20
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Database: Standardized Prenatal Management and Perinatal Outcome of Complicated Monochorionic Pregnancies
    Anticipated Study Start Date :
    Dec 1, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2027
    Anticipated Study Completion Date :
    Dec 1, 2027

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with Preterm Delivery [Up to 42 weeks gestation]

      Preterm delivery is defined as birth <37 weeks gestation

    2. Number of participant with Premature Spontaneous Rupture of the Membranes [Up to 42 weeks]

      As per clinical evaluation

    3. Number of Infant Deaths [Up to 12 months post infant delivery]

      The Number of Infant Deaths

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Miami Miami Florida United States 33136

    Sponsors and Collaborators

    • University of Miami

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rodrigo Ruano, Professor and Chief of MFM Division, University of Miami
    ClinicalTrials.gov Identifier:
    NCT05543499
    Other Study ID Numbers:
    • 20210709
    First Posted:
    Sep 16, 2022
    Last Update Posted:
    Sep 16, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Rodrigo Ruano, Professor and Chief of MFM Division, University of Miami
    multiple pregnancies
    Twins
    Additional relevant MeSH terms:
    Pregnancy Complications
    Fetofetal Transfusion
    Syndrome

    Study Results

    No Results Posted as of Sep 16, 2022