Clinical trial NCT06550232: IV PAPAVERINE Prior to Propess for Labor Induction
Official title: The Effect of IV PAPAVERINE 80 mg Prior to Propess on Bishop Score and Pain, Double Blinded Randomized Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Induced Vaginal Delivery
Keywords: labor induction
papaverine
propess
bishop score
induction to delivery interval
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2024-08-12
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We aim to evaluate the effect of administering papaverine prior to PGE2 (propess) insertion on changes in Bishop-scores and on the induction-to-delivery interval.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* singleton term pregnancy
* bishop score
* need for labor induction with PGE2
* vertex presentation
* viable fetus

Exclusion Criteria:

* Prelabour rupture of membrane
* Twins pregnancy
* previous cesarean section
* allergy to the study medication
* fetal anomaly contraindications for vaginal delivery
* maternal supraventricular tachicardia

Primary outcomes:
measure: Delta Bishop score
timeFrame: 24 hours
measure: visual analogue scale score
timeFrame: 24 hours
Secondary outcomes:
measure: PGE2 insertion-to-delivery interval
timeFrame: hours
Other outcomes:
Locations:
Study officials:
References:
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citation: Ibrahim MI, Alzeeniny HA, Ellaithy MI, Salama AH, Abdellatif MA. Drotaverine to improve progression of labor among nulliparous women. Int J Gynaecol Obstet. 2014 Feb;124(2):112-7. doi: 10.1016/j.ijgo.2013.08.013. Epub 2013 Nov 7.
citation: Madhu C, Mahavarkar S, Bhave S. A randomised controlled study comparing Drotaverine hydrochloride and Valethamate bromide in the augmentation of labour. Arch Gynecol Obstet. 2010 Jul;282(1):11-5. doi: 10.1007/s00404-009-1188-8. Epub 2009 Jul 31.
citation: Yilmaz B, Kart C, Kelekci S, Gokturk U, Sut N, Tarlan N, Mollamahmutoglu L. Meperidine versus valethamate bromide in shortening the duration of active labor. Int J Gynaecol Obstet. 2009 Nov;107(2):126-9. doi: 10.1016/j.ijgo.2009.06.021. Epub 2009 Aug 6.