Objective: The aim of this pilot study was to evaluate whether vaginal progesterone (VP) improves
the effect of cervical pessary (CP) when added in singleton pregnancies with short
cervical length (CL).
Methods: Up to 2011, a CP was the standard procedure to treat risk patients with a history
of spontaneous preterm birth (SPB) and/or conization with a CL < 10th centile and
screening patients with a CL< 3 rd centile with a CP. After the publication of Hassan
et al. (2011), 200 mg VP were additionally applied in these patients (CPVP). Risk
patients (n = 55) were treated from the 1st trimester onwards, patients of the screening
population in the 2nd and early 3 rd trimester (n = 61). Primary outcome was the rate
of SPB < 34 weeks. Secondary outcomes were SPB rates < 28 weeks, < 32 weeks and <
37 weeks, days of prolongation, combined poor neonatal outcome and days of neonatal
admission.
Results: Delivery < 34 weeks occurred in 16/53 patients (30.2%) with both, CP and VP compared
to 15/63 patients (23.8%) treated with CP only (p = 0.736). Delivery < 37 weeks were
observed in 22/53 pregnancies (41.6%) treated with CP and VP compared to 26/63 pregnancies
(41.3%) treated with CP only (p = 0.593). The mean gestational age at delivery was
36 + 1 weeks in both groups (p = 0.72). The composite poor outcome was 15.9% (CP)
versus 15.1% (CP+VP) (p = 0.349); 11 neonates (20.8%) of mothers treated with both,
CP and VP spent 44 (8 – 124) days (mean and range), 15 neonates (23.8%) of the CP
group spent 61 (16 – 142) days on the neonatal intensive care unit (NICU) (p < 0.001).
Conclusion: Additional VP could not prolong pregnancy or prevent any SPB rate compared to CP
alone. Nevertheless, neonates of mothers with both, CP and VP, spent fewer days on
the NICU. Even though short-term neonatal outcome might be in favor of VP added to
CP, long-term outcome is more essential and still has to be critically evaluated in
all infants whose mothers have been treated with progesterone.