Cerclage for Twins With Short Cervix (NCT03077633) | Clinical Trial Compass
WithdrawnPhase 2/3
Cerclage for Twins With Short Cervix
Stopped: Financial/business decision by Sponsor to not proceed with this study
0Started 2017-10-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
2
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.