NCT03077633

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2017

Shorter than P25 for phase_2

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 13, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2018

Completed
Last Updated

March 21, 2018

Status Verified

March 1, 2018

Enrollment Period

4 months

First QC Date

March 3, 2017

Last Update Submit

March 20, 2018

Conditions

Preterm BirthPreterm Labor With Preterm Delivery, Unspecified Trimester, Fetus 2Cervical IncompetenceCervical Shortening

Keywords

CerclageCervical shorteningTwinsProgesterone

Outcome Measures

Primary Outcomes (2)

  • Rate of very preterm birth (PTB)

    Rate of very PTB (PTB less than 32 weeks)

    Time frame measured on the date the infant is born. We anticipate this time frame to be approximately 16 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.

    Time frame measured 28 days after the infant is born. We anticipate this time frame to be approximately 28 weeks.

Study Arms (2)

Cervical Cerclage + Progesterone

ACTIVE COMPARATOR

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

Procedure: Cervical Cerclage placementDrug: Vaginal Progesterone

Progesterone

PLACEBO COMPARATOR

Daily administration of vaginal progesterone (200mg tab)

Drug: Vaginal Progesterone

Interventions

Cervical Cerclage placementPROCEDURE

Cervical Cerclage placement

Cervical Cerclage + Progesterone
Vaginal ProgesteroneDRUG

200mg tab of vaginal progesterone administered daily from time of randomization until delivery.

Also known as: Prometrium
Cervical Cerclage + ProgesteroneProgesterone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Premature BirthUterine Cervical Incompetence

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesAbortion, HabitualAbortion, SpontaneousGenital Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Study Officials

  • Andrew Combs, MD

    Pediatrix

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Two groups: Cerclage + Progesterone vs. Progesterone alone
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2017

First Posted

March 13, 2017

Study Start

October 1, 2017

Primary Completion

January 17, 2018

Study Completion

January 17, 2018

Last Updated

March 21, 2018

Record last verified: 2018-03