Cerclage for Twins With Short Cervix

March 20, 2018 updated by: Pediatrix

Cervical Cerclage for Twin Pregnancy With Sonographic Cervical Length 0.1 to 15.0 mm: A Randomized Clinical Trial

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.

Study Overview

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.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Cervical Cerclage + Progesterone
Placement of a Cervical Cerclage plus the daily administration of vaginal progesterone (200mg tab)
Cervical Cerclage placement
200mg tab of vaginal progesterone administered daily from time of randomization until delivery.
Other Names:
  • Prometrium
PLACEBO_COMPARATOR: Progesterone
Daily administration of vaginal progesterone (200mg tab)
200mg tab of vaginal progesterone administered daily from time of randomization until delivery.
Other Names:
  • Prometrium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of very preterm birth (PTB)
Time Frame: Time frame measured on the date the infant is born. We anticipate this time frame to be approximately 16 weeks.
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
Time Frame: Time frame measured 28 days after the infant is born. We anticipate this time frame to be approximately 28 weeks.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Andrew Combs, MD, Pediatrix

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2017

Primary Completion (ACTUAL)

January 17, 2018

Study Completion (ACTUAL)

January 17, 2018

Study Registration Dates

First Submitted

March 3, 2017

First Submitted That Met QC Criteria

March 10, 2017

First Posted (ACTUAL)

March 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 21, 2018

Last Update Submitted That Met QC Criteria

March 20, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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