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Cerclage for Twins With Short Cervix

Primary Purpose

Preterm Birth, Preterm Labor With Preterm Delivery, Unspecified Trimester, Fetus 2, Cervical Incompetence

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cervical Cerclage placement
Vaginal Progesterone
Sponsored by
Pediatrix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Birth focused on measuring Cerclage, Cervical shortening, Twins, Progesterone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Twin pregnancy (see Exclusion Criterion (a) below re: monochorionic twins)
  • Gestational age 16 0/7 to 25 6/7 weeks at time of enrollment by best-estimated age.
  • Cervical length 0.1 to 15.0 mm on transvaginal ultrasound examination. (Cervical length is taken to mean the length of the closed portion of the cervical canal.

Exclusion Criteria:

  • Maternal age less than 18 years
  • Monochorionic twins (such as monochorionic-diamniotic, monochorionic-monoamniotic, or conjoined twins)
  • Rupture of membranes, either twin
  • One or both twins has no cardiac activity
  • One or both twins has known or suspected major malformation, aneuploidy, or polyhydramnios
  • Maternal congenital uterine anomaly (such as bicornuate uterus, unicornuate uterus)
  • Pregnancy started as triplets or higher-order multifetal gestation and then reduced to twins, either spontaneously or via procedure
  • Symptomatic uterine contractions, 6 or more per hour
  • Ongoing bleeding from uterus
  • Patient declines to consider cerclage
  • Patient declines treatment with vaginal progesterone
  • Allergy to progesterone or peanuts (because the vaginal progesterone formulation used will be a capsule of micronized progesterone in peanut oil.)
  • Cerclage is already in place
  • Cerclage placement is judged to be technically impossible
  • Patient has a history of poor follow-up or poor adherence to physician recommendations
  • Patient is planning to relocate outside the local area before the end of pregnancy such that delivery records will be unavailable
  • Patient does not give consent to participate in this trial.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Cervical Cerclage + Progesterone

    Progesterone

    Arm Description

    Placement of a Cervical Cerclage plus the daily administration of vaginal progesterone (200mg tab)

    Daily administration of vaginal progesterone (200mg tab)

    Outcomes

    Primary Outcome Measures

    Rate of very preterm birth (PTB)
    Rate of very PTB (PTB less than 32 weeks)
    Rate of adverse perinatal outcome
    The rate of adverse perinatal outcome defined as any one or more of the following: Miscarriage, stillbirth, neonatal death, respiratory distress syndrome, bronchopulmonary dysplasia, intraventricular hemorrhage (grade III or IV), necrotizing enterocolitis, culture proven sepsis.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 3, 2017
    Last Updated
    March 20, 2018
    Sponsor
    Pediatrix
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03077633
    Brief Title
    Cerclage for Twins With Short Cervix
    Official Title
    Cervical Cerclage for Twin Pregnancy With Sonographic Cervical Length 0.1 to 15.0 mm: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Financial/business decision by Sponsor to not proceed with this study
    Study Start Date
    October 1, 2017 (Anticipated)
    Primary Completion Date
    January 17, 2018 (Actual)
    Study Completion Date
    January 17, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pediatrix

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A prospective randomized control trial that will compare cervical cerclage plus vaginal progesterone to vaginal progesterone along in twin pregnancies complicate by a short cervix (</= 15.0mm) between 16w0d to 25w6d.
    Detailed Description
    A prospective Randomized Trial that will test whether treatment with cervical cerclage plus vaginal progesterone improves pregnancy outcomes among women with twin pregnancy at 16 0/7 to 25 6/7 weeks of gestation who have a cervical length (CL) of 0.1 to 15.0 mm on transvaginal ultrasound exam, the rate of preterm birth at less than 32 weeks of gestation (PTB<32 wks.) and the rate of adverse perinatal outcome will be lower in those treated with cervical cerclage plus vaginal progesterone than in those treated with vaginal progesterone alone.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Preterm Birth, Preterm Labor With Preterm Delivery, Unspecified Trimester, Fetus 2, Cervical Incompetence, Cervical Shortening
    Keywords
    Cerclage, Cervical shortening, Twins, Progesterone

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Two groups: Cerclage + Progesterone vs. Progesterone alone
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cervical Cerclage + Progesterone
    Arm Type
    Active Comparator
    Arm Description
    Placement of a Cervical Cerclage plus the daily administration of vaginal progesterone (200mg tab)
    Arm Title
    Progesterone
    Arm Type
    Placebo Comparator
    Arm Description
    Daily administration of vaginal progesterone (200mg tab)
    Intervention Type
    Procedure
    Intervention Name(s)
    Cervical Cerclage placement
    Intervention Description
    Cervical Cerclage placement
    Intervention Type
    Drug
    Intervention Name(s)
    Vaginal Progesterone
    Other Intervention Name(s)
    Prometrium
    Intervention Description
    200mg tab of vaginal progesterone administered daily from time of randomization until delivery.
    Primary Outcome Measure Information:
    Title
    Rate of very preterm birth (PTB)
    Description
    Rate of very PTB (PTB less than 32 weeks)
    Time Frame
    Time frame measured on the date the infant is born. We anticipate this time frame to be approximately 16 weeks.
    Title
    Rate of adverse perinatal outcome
    Description
    The rate of adverse perinatal outcome defined as any one or more of the following: Miscarriage, stillbirth, neonatal death, respiratory distress syndrome, bronchopulmonary dysplasia, intraventricular hemorrhage (grade III or IV), necrotizing enterocolitis, culture proven sepsis.
    Time Frame
    Time frame measured 28 days after the infant is born. We anticipate this time frame to be approximately 28 weeks.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Twin pregnancy (see Exclusion Criterion (a) below re: monochorionic twins) Gestational age 16 0/7 to 25 6/7 weeks at time of enrollment by best-estimated age. Cervical length 0.1 to 15.0 mm on transvaginal ultrasound examination. (Cervical length is taken to mean the length of the closed portion of the cervical canal. Exclusion Criteria: Maternal age less than 18 years Monochorionic twins (such as monochorionic-diamniotic, monochorionic-monoamniotic, or conjoined twins) Rupture of membranes, either twin One or both twins has no cardiac activity One or both twins has known or suspected major malformation, aneuploidy, or polyhydramnios Maternal congenital uterine anomaly (such as bicornuate uterus, unicornuate uterus) Pregnancy started as triplets or higher-order multifetal gestation and then reduced to twins, either spontaneously or via procedure Symptomatic uterine contractions, 6 or more per hour Ongoing bleeding from uterus Patient declines to consider cerclage Patient declines treatment with vaginal progesterone Allergy to progesterone or peanuts (because the vaginal progesterone formulation used will be a capsule of micronized progesterone in peanut oil.) Cerclage is already in place Cerclage placement is judged to be technically impossible Patient has a history of poor follow-up or poor adherence to physician recommendations Patient is planning to relocate outside the local area before the end of pregnancy such that delivery records will be unavailable Patient does not give consent to participate in this trial.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andrew Combs, MD
    Organizational Affiliation
    Pediatrix
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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