Actively Recruiting
Cerclage for the Reduction of Extreme Preterm Birth in Twin Pregnancies With a Short Cervix or Dilatation
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2023-11-13
238
Participants Needed
13
Research Sites
289 weeks
Total Duration
On this page
Sponsors
A
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead Sponsor
Z
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
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? Participants will be randomly assigned to the intervention (cerclage) or comparison (no cerclage) group.
CONDITIONS
Official Title
Cerclage for the Reduction of Extreme Preterm Birth in Twin Pregnancies With a Short Cervix or Dilatation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 16 years or older
- Twin pregnancy
- Asymptomatic short cervix before 24 weeks of gestation OR cervical dilatation before 24 weeks of gestation
You will not qualify if you...
- Mono-amniotic twin pregnancy
- Twin pregnancy with one or both children having major structural, congenital, or chromosomal abnormalities likely to affect neonatal outcome
- Cervical dilatation with signs of clinical intra-uterine infection (fever 38 degrees Celsius)
- Overt symptoms of preterm labor at time of short cervix measurement (regular contractions, premature rupture of membranes, recurrent blood loss)
- Placenta previa covering the cervix opening
- Inability to understand Dutch or English languages to provide written consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
University Medical Center Antwerpen
Antwerp, Belgium
Not Yet Recruiting
2
University Medical Center Sint-Lucas Brugge
Bruges, Belgium
Not Yet Recruiting
3
Hospital Oost-Limburg Genk
Genk, Belgium
Not Yet Recruiting
4
University Medical Center Gent
Ghent, Belgium
Not Yet Recruiting
5
University Medical Center Leuven
Leuven, Belgium
Not Yet Recruiting
6
University Medical Center Amsterdam
Amsterdam, Netherlands
Actively Recruiting
7
University Medical Center Groningen
Groningen, Netherlands
Not Yet Recruiting
8
University Medical Center Leiden
Leiden, Netherlands
Not Yet Recruiting
9
University Medical Center Maastricht
Maastricht, Netherlands
Not Yet Recruiting
10
Radboud University Medical Center
Nijmegen, Netherlands
Not Yet Recruiting
11
Erasmus Medical Centre
Rotterdam, Netherlands
Not Yet Recruiting
12
University Medical Center Utrecht
Utrecht, Netherlands
Not Yet Recruiting
13
Maxima Medical Centre
Veldhoven, Netherlands
Not Yet Recruiting
Research Team
L
Lissa van gils, MD
CONTACT
M
Martijn A Oudijk, MD, PhD, Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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