Cerclage Plus Progesterone vs Progesterone Alone in Twin Short Cervix (NCT07372495) | Clinical Trial Compass
RecruitingNot Applicable
Cerclage Plus Progesterone vs Progesterone Alone in Twin Short Cervix
Vietnam260 participantsStarted 2026-04-10
Plain-language summary
This study aims to compare the effectiveness of cervical cerclage combined with progesterone versus progesterone alone in preventing preterm birth among women with twin pregnancies and a short cervix (cervical length ≤ 30 mm). Participants will be randomly allocated to either the intervention group (cerclage plus progesterone) or the control group (progesterone alone).
Who can participate
Age range
18 Years
Sex
FEMALE
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:
* Maternal age ≥ 18
* Twin pregnancy
* Asymptomatic short cervix (CL≤30mm) at routine ultrasound investigation
* Gestational age at 16+0- 24+0 weeks
Exclusion Criteria:
A potential paticipant who meets any of the following criteria will be excluded from participation in this trial:
* Women with twin pregnancy in which one or both fetuses are diagnosed with a major structural or congenital abnormality that is likely to influence the composite adverse neonatal outcome.
* Women with a monochorionic monoamniotic twin pregnancy
* A monochorionic twin pregnancy with twin-to-twin transfusion syndrome before or at the time of inclusion.
* Patients have indications for vaginal cerclage: Recurrent late miscarriage (from 14 weeks) or preterm birth occurring two or more times.
* Women with dilatation of the cervix diagnosed by ultrasound or physical exam
* Women with overt symptoms of preterm labor at the time of measurement of the short cervix (regular contractions, PPROM, recurrent blood loss).
* Women with the presence of fever ≥ 38 degrees Celsius.
* Women with a placenta previa, vasa previa.
* Uterine malformations: unicornuate uterus, bicornuate uterus, uterine septum, fibroid…
* Severe maternal conditions (heart failure, chronic kidney disease, systemic lupus erythematosus …)
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
Preterm birth < 28 weeks
Timeframe: From randomization until 27 6/7 weeks
Trial details
NCT IDNCT07372495
SponsorNational Hospital of Obstetrics and Gynecology