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Pessary IMPlementation Project / Pessarium IMPlementatie Project (PIMPP)



Go to the PIMPP website.


Objective
In women with a multiple pregnancy, spontaneous preterm delivery is the leading cause of perinatal morbidity and mortality (1, 2). In the Netherlands approximately 50% of women with a multiple pregnancy deliver before 37 weeks of gestation, of whom 9% even prior to 32 weeks (3).
The ProTWIN study, a nationwide multicenter randomized clinical trial, allocated women with a multiple pregnancy for cervical pessary treatment or no pessary. The results of this study showed a significant reduction in both poor perinatal outcome and very preterm birth rates  in women with a cervical length below the 25th percentile (38 mm) at 16-22 weeks of gestation in favour of the cervical pessary group. The percentage of extremely preterm birth decreased from 29% to 14% and the neonatal death percentage decreased from 18% to 3% (ProTWIN-trial).
The objective of the Pessary IMPlementation Project (PIMPP) is to evaluate whether these results, stated in the ProTWIN-trial, persist when implemented in daily practice.

Study design
Nationwide multicenter prospective cohort study.

Study population
All women with a multiple pregnancy who received a pessary at a gestational age of 16 to 22 weeks, because of a cervical length < 25th percentile (38 mm).  
This cohort will be compared with a historical control cohort of the AMPHIA- and Pro-TWIN trial.

Intervention
All women with a multiple pregnancy and a cervical length shorter than 38mm (25th percentile) at a gestational age of 16 to 22 weeks, will receive a cervical pessary (Arabin) before the gestational age of 22 weeks. The cervical pessary will be removed at a gestational age of 36 weeks unless the patient has: complaints of severe pain (because of the pessary); vaginal blood loss; in case of premature rupture of membranes; or if the patient falls into labour.

Outcome measures
Primary outcome measure is a composite outcome of poor perinatal outcome (Death, PVL, BPD, IVH, NEC, Sepsis).
Secondary outcome measures are time to delivery, days of admission to a neonatal intensive care unit (NICU), side-effects of pessary treatment and maternal morbidity.

Time schedule
Duration of the inclusion period will be 18 months and 6 months of data collections. We expect the first results in the beginning of 2015.

Projectleaders
Prof. Dr. B.W. Mol
Dr. D. Bekedam
Drs. S. Liem
Drs. M. Monfrance
Dr. J. Langenveld
Ir. E. Schuit

Contact (researcher)

Drs. Maurice Monfrance
Cohort.protwin@gmail.com
Tel: 06-55825503

Literature
    1.     Hille ET, Weisglas-Kuperus N, van Goudoever JB et al. Functional outcomes and participation in young adulthood for very preterm and very low birth weight infants: the Dutch Project on Preterm and Small for Gestational Age Infants at 19 years of age. Pediatrics 2007;120(3):e587-e595.
    2.     Chang HH, Larson J, Blencowe H et al. Preventing preterm births: analysis of trends and potential reductions with interventions in 39 countries with very high human development index. Lancet 2013;381(9862):223-234.
    3.     Schaaf JM, Mol BW, Abu-Hanna A, Ravelli AC. Trends in preterm birth: singleton and multiple pregnancies in the Netherlands, 2000-2007. BJOG 2011;118(10):1196-1204.