PeRinatal Outcomes With ACTive Versus Expectant Management of Women With Pre-labor Rupture Of Membranes (PROACT PROM)
Rupture of Membranes; Premature, Distress; Fetal, Complicating Delivery, Delayed Delivery After Spontaneous or Unspecified Rupture of Membranes
About this trial
This is an interventional prevention trial for Rupture of Membranes; Premature
Eligibility Criteria
Inclusion Criteria: Age ≥18 years of age at the time of randomization Gestational age ≥ 37 weeks Negative rectovaginal GBS swab Absent/poor uterine contractile activity 6 h after PROM (0-2 contractions /10 min) Cephalic presentation Ability to provide an informed consent Signed informed consent Exclusion Criteria: Prematurity (<37 weeks) GBS positive vagino-rectal swab or with an unknown swab Multiple pregnancies Previous cesarean section (CS) Breech presentation, transverse lie or other indication for elective CS Suspected clinic for intra-amniotic infection (According to the Triple I criteria) Stained amniotic fluid Alterations of the FHR Unknown exact ROM time Known hypersensitivity to drugs for IOL or their excipients Presence of unknown vaginal bleeding Presence of maternal kidney disease (GFR <15 ml/min/1,73 m2). Every condition contraindicating vaginal delivery
Sites / Locations
- AUO Policlinico di Modena
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
active management
Expectant management
early IOL within 8 hours of rupture of membranes. Center-specific IOL protocols will be used.
monitoring until 24 hours from rupture of membranes, with subsequent induction of labor (IOL).