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New treatment option for Premature Birth
Official title LATe Cerclage in High-risk Pregnancies (LATCH)
ClinicalTrials.gov ID: NCT06036446
What this study is testing
What is Vaginal Suppository Progesterone?
Vaginal Suppository Progesterone is an investigational medicine, given as an once-daily, being studied as a potential treatment for premature birth.
Also referred to as Vaginal progesterone.
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
- The goal of this clinical trial is to determine whether cervical cerclage reduces the risk of preterm birth in patients with a short transvaginal ultrasound (TVU) cervical length (CL) ≤25mm between 24 0/7-26 6/7 weeks.
- 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 to 50, women only. Healthy volunteers may be eligible.
You may be able to join if
- 18-50 years old, pregnant, assigned female at birth
- Singleton pregnancy
- TVU CL ≤25mm between 24 0/7 - 26 6/7 weeks of gestation
You likely can't join if
- Initial multifetal gestation with subsequent multifetal pregnancy reduction, or selective fetal termination performed \>14 weeks, or cotwin pregnancy...
- Cerclage in situ
- Preterm labor, defined as painful regular uterine contractions and change in cervical dilation
- PPROM
- Active vaginal bleeding
- Suspected intraamniotic infection
See the full eligibility criteria
- 18-50 years old, pregnant, assigned female at birth
- Singleton pregnancy
- TVU CL ≤25mm between 24 0/7 - 26 6/7 weeks of gestation
- Initial multifetal gestation with subsequent multifetal pregnancy reduction, or selective fetal termination performed \>14 weeks, or cotwin pregnancy loss diagnosed \>14 weeks
- Cerclage in situ
- Preterm labor, defined as painful regular uterine contractions and change in cervical dilation
- PPROM
- Active vaginal bleeding
- Suspected intraamniotic infection
- Major fetal structural abnormality or chromosomal disorder
- Placenta previa or accreta
- Other contraindication to cerclage placement
- Participation in another clinical trial related to preterm birth prevention, cerclage, or progesterone
The study team makes the final eligibility decision.
Where it's taking place
- Charlotte, North Carolina, United States
- Philadelphia, Pennsylvania, United States
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 to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlotte, North Carolina, United States; Philadelphia, Pennsylvania, United States. 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.