Cerclage for Twins With Short Cervix

• Status: Withdrawn
• Trial end date: 2018-01-17
• Target enrollment: 0
• Participant gender: All

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 (Phase: Phase 2/Phase 3

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mednax Center for Research, Education and Quality; Mednax Center for Research, Education, Quality and Safety
• Treatments: Progesterone

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.