Last updated: June 27, 2023
Sponsor: Western Galilee Hospital-Nahariya
Overall Status: Active - Recruiting
Phase
N/A
Condition
Acute Pain
Pain
Treatment
IV Papaverine 80 mg
Placebo
Clinical Study ID
NCT05759364
0012-23-NHR
Ages 18-50 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Women with a singleton pregnancy, over the age of 18, pregnant at term (ie betweenweeks 37-42)
- Bishop score is less than 6, for which a medical decision was made regarding theinduction of labor by catheter
- Vertex presentation, intact membranes
- Viable fetus
Exclusion
Exclusion Criteria:
- Twin pregnancy
- Women after caesarean section
- Severe fetal anomalies
- Women with vaginismus or vulvodynia
- Women with psychiatric illnesses including depression and schizophrenia
- Contraindication for vaginal delivery
- A woman who is unable to sign a consent form
- Women are known for supraventricular tachycardia
- Women with tachycardia over 100 or arrhythmia
- Known sensitivity to one of the components of the drug
- Liver disease
Study Design
Total Participants: 128
Treatment Group(s): 2
Primary Treatment: IV Papaverine 80 mg
Phase:
Study Start date:
May 15, 2023
Estimated Completion Date:
April 01, 2025
Study Description
Connect with a study center
Galilee Medical Center
Nahariya, Hazafon
IsraelActive - Recruiting
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