The investigators aim to evaluate the effect of administering papaverine prior to PGE2 insertion on changes in Bishop-scores and on the induction-to-delivery interval. Researchers will compare drug papaverine to a placebo
More than 22% of all pregnant women undergo induction of labor. Induction of labor is usually medically indicated for maternal and fetal related conditions; however, elective induction has become more common since the ARRIVE trial. Women with an unfavourable cervix, according to Bishop-score (\<6), are prone to higher induction failure rates and are candidates for cervical ripening. The cervix is composed of connective tissue and smooth-muscle located mainly beneath the internal os. Papaverine is an antispasmodic-musculotropic drug that targets smooth-muscle, resulting in decreased muscle spasm and subsequent smooth-muscle relaxation. The half-life of the drug is in the range of 0.5-2 hours, and its action starts 10 minutes after administration. Short-term use of papaverine during the first trimester has been reported as safe. However, outcome data are lacking of the use of mucosotropic-agents prior to PGE2 (propess) insertion. We will investigate this in a trial in which the co-primary outcomes were the change in Bishop-score after PGE2 extraction and the PGE2 insertion-to-delivery interval
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
110
Within 30-minutes prior to catheter insertion, women in the intervention group will receive IV-papaverine 80 mg in 100 ml 0.9% saline
I.V Sallne
Galilee Medical Center
Nahariya, Israel
Delta Bishop score
The bishop score before and after propess insertion
Time frame: 24 hours
the time from propess insertion until delivery
induction to delivery time
Time frame: 72 hours
maternal satisfaction scores
maternal satisfaction on 1-5 scale. higher scores mean higher satisfaction
Time frame: 24 hours
visual analogue scale score
pain assessment using a 10-point visual analogue scale
Time frame: 24 hours
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