This prospective randomized controlled trial aims to evaluate whether intravenous administration of papaverine 12 hours after term PROM reduces the interval from membrane rupture to delivery and improves maternal and neonatal outcomes. Researchers will compare drug papaverine to a placebo

Prelabor rupture of membranes (PROM) at term complicates approximately 8% of pregnancies and is associated with increasing maternal and neonatal infectious morbidity as the latency period to delivery lengthens. Consequently, most clinical guidelines recommend active management with labor induction within 24 hours following membrane rupture. Cervical status at the time of induction plays a critical role in labor outcomes, and women with an unfavorable cervix, commonly defined as a Bishop score below 8, are at increased risk of prolonged labor and induction failure. The uterine cervix is composed primarily of connective tissue, with smooth muscle accounting for approximately 15% of its structure and concentrated mainly beneath the internal cervical os. Papaverine is a musculotropic antispasmodic agent that acts directly on smooth muscle, leading to reduced muscle spasm and enhanced relaxation. The pharmacokinetic profile of papaverine includes a rapid onset of action within approximately 10 minutes and a short half-life of 0.5-2 hours, making it a potentially suitable adjunct during early labor. Antispasmodic agents have been shown to accelerate cervical dilatation and shorten the first stage of labor; however, their role in the management of term PROM has not been systematically evaluated. We therefore aim to investigate whether intravenous administration of papaverine in women with term PROM shortens the interval from membrane rupture to delivery and improves cervical ripening and maternal and neonatal outcomes.

Inclusion Criteria:

• • Singleton pregnancy

  • Term gestation (37-42 weeks)
  • Term PROM prior to active labor
  • Duration of PROM <12 hours at enrollment
  • Bishop score <8
  • Cephalic presentation
  • Viable fetus with reassuring fetal heart rate

Exclusion Criteria:

• • Multiple gestation

  • Previous cesarean delivery
  • Major fetal anomalies
  • Contraindication to vaginal delivery
  • Meconium-stained amniotic fluid
  • Suspected chorioamnionitis

pregnant women

The authors are willing to share the data of the study upon request of the Editors.

The group allocation will be double blind. The randomization table will be available only to one member of the study, who will prepare the medications according to the allocated intervention. Participants will receive intravenous 0.9% normal saline with or without papaverine. The same bottles of normal saline will be use for the papaverine and placebo groups. Accordingly, the participants will be masked for the intervention. The participants, the researchers including the obstetricians who assess the bishop score, the caregiver nurse who administrated the medication, the data collector, and the statistician will be blinded to the group allocations throughout the study