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PC-study


Pessary or Cerclage to prevent preterm delivery in women with short cervical length and a history of preterm birth

 

Go to the PC website


 
Preterm birth (PTB) is in quantity and in severity the most important pregnancy complication in obstetric care in the developed world. A cervical pessary and  a cervical cerclage are both considered as potential preventive treatments for PTB in women with a history of preterm birth or women with a short cervical length.

 

Objective:
To evaluate whether a cervical pessary can replace a cervical cerclage in women with at least one previous preterm birth and an indication for a primary or secondary cerclage in terms of effectiveness and costs.

 

Study design:
International open-label multicenter randomized clinical trial.

 

Study population:
Asymptomatic women with a singleton pregnancy and at least one previous preterm birth before 34 weeks of gestation with an indication for a primairy OR secondary cerclage can participate in the study.
- Primary intervention
Women with an indication for a primary cerclage (according to local protocol)
OR
- Secondary intervention
Women with a cervical length of 25 mm or shorter (25mm) before 24 weeks of gestation

 

Intervention:
Eligible women will be randomized between a cervical pessary or cervical cerclage.

 
Outcome measures:
The primary outcome will be delivery before 32 weeks. Secondary outcomes will be preterm rate birth before 24, 28, 34 and 37 weeks, time from intervention to delivery, (early) premature rupture of membranes, maternal infection, maternal side effects and composite bad neonatal outcome including both morbidity and mortality rate of children.

 

Power/data analysis:
The analysis of the trial will be by intention to treat.

 

Time schedule:
48 months

 

Project group
drs. L.E.M. van Kempen, researcher AMC Amsterdam
E. Pajkrt, gynaecologist, MD PhD, AMC Amsterdam
prof. B.W.J. Mol, MD PhD, gynaecologist, Adelaide Australia
D.J. Bekedam, MD PhD, gynaecologist, OLVG Amsterdam
K.W.M. Bloemenkamp, MD PhD, gynaecologist, LUMC Leiden
B.C. Opmeer, MD PhD, epidemiologist, AMC Amsterdam
M.A. Oudijk, MD PhD, gynaecologist, UMC Utrecht
F.J.R. Hermans, MD, researcher, AMC Amsterdam

 

Methodology
E. Schuit, PhD, epidemiologist, UMC Utrecht
C. Naaktgeboren, MSc, epidemiologist, UMC Utrecht

 

Contact
Liselotte van Kempen, AMC
pc@studies-obsgyn.nl