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Compares treatment options for Preterm
Official title Cerclage Plus Progesterone vs Progesterone Alone in Twin Short Cervix
ClinicalTrials.gov ID: NCT07372495
What this study is testing
What is Progesterone?
Progesterone is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for preterm.
Also referred to as Utrogestan 200mg.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Maternal age ≥ 18
- Twin pregnancy
- Asymptomatic short cervix (CL≤30mm) at routine ultrasound investigation
- Gestational age at 16+0- 24+0 weeks
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- Maternal age ≥ 18
- Twin pregnancy
- Asymptomatic short cervix (CL≤30mm) at routine ultrasound investigation
- Gestational age at 16+0- 24+0 weeks
- 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 …)
The study team makes the final eligibility decision.
Where it's taking place
- Bac Ninh, Vietnam
- Hanoi, Vietnam
- Hung Yen, Vietnam
- Ninh Binh, Vietnam
- Quang Ninh, Vietnam
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bac Ninh, Vietnam; Hanoi, Vietnam; Hung Yen, Vietnam; Ninh Binh, Vietnam; Quang Ninh, Vietnam. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.