Cerclage for Twins With Short Cervix

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2018-01-17

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups: Cerclage + Progesterone vs. Progesterone alone

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cervical Cerclage + Progesterone

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

Group Type ACTIVE_COMPARATOR

Cervical Cerclage placement

Intervention Type PROCEDURE

Cervical Cerclage placement

Vaginal Progesterone

Intervention Type DRUG

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

Progesterone

Daily administration of vaginal progesterone (200mg tab)

Group Type PLACEBO_COMPARATOR

Vaginal Progesterone

Intervention Type DRUG

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

Interventions

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Cervical Cerclage placement

Intervention Type PROCEDURE

Vaginal Progesterone

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

Intervention Type DRUG

Other Intervention Names

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Prometrium

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes