Health TrialsbyHealthPanel

Papaverine and Oxytocin vs Oxytocin Alone in Labor Induction

ConditionsInduced; BirthLabor Onset and Length Abnormalities
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorWestern Galilee Hospital-Nahariya

About this trial

This study aims to evaluate the efficacy and safety of combining papaverine with oxytocin for labor induction compared to oxytocin alone

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Women with a singleton pregnancy Over the age of 18 Term (between 37-42 weeks of gestation) A medical decision for labor induction using oxytocin. Cephalic presentation Viable fetus nulliparity

Disqualifiers

parity >1

Twin pregnancy Women with a previous cesarean section Severe fetal anomalies Women with psychiatric disorders, including depression and schizophrenia. Contraindication to vaginal delivery Women unable to sign the consent form Women known to have SVT (supraventricular tachycardia). Women with a heart rate over 100 or arrhythmia Known sensitivity to any component of the drug Liver disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Papaverine

    Drug

    papaverine a smooth muscle relaxant

  • normal saline

    Drug

    normal saline 0.9% 100 cc

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: oxytocin plus papaverineActive comparator 1 intervention
Group B: oxytocin alonePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

time to active delivery

time from labor induction till dilatation of 6 cm

Time frame
24 HOURS AFTER DELIVERY

Secondary outcomes

1

vaginal deliveries in 24 hours

rate of vaginal deliveries in 24 hours

Time frame
24 HOURS AFTER DELIVERY
2

total length of labor

time for induction to delivery

Time frame
24 HOURS AFTER DELIVERY
3

cesarean delivery rate

rate of emergent cesarean delivery during labor

Time frame
ho24 HOURS AFTER DELIVERY
4

length of second stage of labor

second stage of labor in hours

Time frame
24 hours after delivery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Western Galilee Hospital-Nahariya

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: