Clinical trial NCT03077633: 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
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Preterm Birth
Preterm Labor With Preterm Delivery, Unspecified Trimester, Fetus 2
Cervical Incompetence
Cervical Shortening
Keywords: Cerclage
Cervical shortening
Twins
Progesterone
Lead sponsor: Pediatrix
Sponsor class: OTHER
First posted: 2017-03-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups: Cerclage + Progesterone vs. Progesterone alone
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Rate of very preterm birth (PTB)
timeFrame: Time frame measured on the date the infant is born. We anticipate this time frame to be approximately 16 weeks.
measure: Rate of adverse perinatal outcome
timeFrame: Time frame measured 28 days after the infant is born. We anticipate this time frame to be approximately 28 weeks.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pediatrix
name: Andrew Combs, MD
role: PRINCIPAL_INVESTIGATOR
References: