Premature Rupture of Membranes
Conditions
Keywords
premature rupture of membranes, papaverine, bishop score
Brief summary
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
Detailed description
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.
Interventions
DRUGPapaverine arm
given 12 houres after rupture of membranes
OTHERPlacebo
I.V seline
Sponsors
Western Galilee Hospital-Nahariya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time interval from rupture of membranes to delivery | up to 5 days from rupture of membranes | Time from rupture of membrane to delivery, measured in hours, including pre and post intervention periods |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in bishop score following intervention | baseline to 6-12 hours after intervention | Bishop score messured at admission and 18 houres after rupture of membranes, and comparing the delta bishop scores between the groups |
| mode of delivary | At delivery/birth | Mode of delivery categorized as vaginal (spontaneous or operative) or cesarean delivery |
Countries
Israel
Contacts
CONTACTMaya Frank Wolf, professor
Outcome results
None listed