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New treatment option for Preterm Birth
Official title Cerclage for the Reduction of Extreme Preterm Birth in Twin Pregnancies With a Short Cervix or Dilatation
ClinicalTrials.gov ID: NCT05968794
What this study is testing
- What it's testing
- The goal of this clinical trial is to assess the effectiveness of a cerclage in women with a twin pregnancy with a midpregnancy short cervix or cervical dilatation compared to standard treatment (no cerclage) in the prevention of extreme preterm birth \< 28 weeks of gestational age. The main question it aims to answer is: What is the effectiveness of a cerclage in women with a twin pregnancy with a midpregnancy short cervix or cervical dilatation compared to standard treatment (no cerclage) in the prevention of extreme preterm birth \< 28 weeks of gestational age?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- Women (\> 16 years of age) with a twin pregnancy and:
- an asymptomatic short cervix at routine ultrasound investigation (below 24 weeks of gestation) OR
- cervical dilatation (below 24 weeks of gestation)
You likely can't join if
- Women with a mono-amniotic twin pregnancy
- Women with twin pregnancy in which one or both children are diagnosed with a major structural, congenital or chromosomal abnormality that is likely...
- Women with dilatation of the cervix and signs of clinical intra-uterine infection, defined by the presence of fever ≥ 38 degrees Celsius.
- Women with overt symptoms of preterm labour at time of measurement of short cervix (regular contractions, PPROM, recurrent blood loss).
- Women with a placenta previa, defined as a placenta position covering the internal ostium of the cervix.
- Women who do not master the Dutch of English language and therefore not able to give written consent
The study team makes the final eligibility decision.
Where it's taking place
- Antwerp, Belgium
- Bruges, Belgium
- Genk, Belgium
- Ghent, Belgium
- Leuven, Belgium
- Amsterdam, Netherlands
- Groningen, Netherlands
- Leiden, Netherlands
- Maastricht, Netherlands
- Nijmegen, Netherlands
- Rotterdam, Netherlands
- Utrecht, Netherlands
- Veldhoven, Netherlands
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, 16 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Antwerp, Belgium; Bruges, Belgium; Genk, Belgium; Ghent, Belgium; Leuven, Belgium; Amsterdam, Netherlands and 7 more location(s). 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.