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Compares treatment options for Preterm Birth
Official title Cerclage With Progesterone Versus Progesterone Only in Singleton Pregnancies
ClinicalTrials.gov ID: NCT06463652
What this study is testing
What is Vaginal progesterone?
Vaginal progesterone is an investigational medicine, given as an once-daily, being studied as a potential treatment for preterm birth.
Also referred to as Cyclogest® 200 mg.
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 compares the effectiveness of cervical cerclage with vaginal progesterone to vaginal progesterone only for the prevention of preterm birth in women with a singleton pregnancy and a short cervical length. Participants will be randomly assigned in a 1:1 ratio to receive cerclage plus progesterone or progesterone only.
- 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 years
- Singleton pregnancy
- Cervical length ≤ 25 mm, measured by TVS at the second-trimester ultrasonography (16 0/7 - 24 0/7 weeks of gestation)
- Not participating in any other study which has intervention on maternity or fetus
- Provision of written informed consent as shown by a signature on the participant consent form.
You likely can't join if
- Cervical dilation with visible amniotic membranes or amniotic membranes prolapsed into the vagina
- Major congenital abnormalities of the fetus
- Intrauterine fetal demise
- Presence of severe vaginal discharge\
- Presence of vaginitis or cervicitis\
- Presence of vaginal bleeding\
See the full eligibility criteria
- Maternal age ≥18 years
- Singleton pregnancy
- Cervical length ≤ 25 mm, measured by TVS at the second-trimester ultrasonography (16 0/7 - 24 0/7 weeks of gestation)
- Not participating in any other study which has intervention on maternity or fetus
- Provision of written informed consent as shown by a signature on the participant consent form.
- Cervical dilation with visible amniotic membranes or amniotic membranes prolapsed into the vagina
- Major congenital abnormalities of the fetus
- Intrauterine fetal demise
- Presence of severe vaginal discharge\
- Presence of vaginitis or cervicitis\
- Presence of vaginal bleeding\
- Placenta previa or vasa previa
- Preterm premature rupture of membranes
- Preterm labor without ruptured membrane at the time of screening
- Suspected chorioamnionitis
- Unable to undergo cerclage
- Cerclage in place
- Allergy to progesterone (\ Women with acute cervicitis, vaginitis or severe vaginal discharge are eligible once they have been treated and if they have a CL ≤25 mm between 16 0/7 - 24 0/7 weeks of gestation.)
The study team makes the final eligibility decision.
Where it's taking place
- Ho Chi Minh City, Ho Chi Minh City, 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 Ho Chi Minh City, Ho Chi Minh City, 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.