PGE2 Followed by Oxytocin vs Oxytocin in Term PROM (POXY-PROM)

Number of participants delivered vaginally

Number of participants according to mode of delivery, categorized as vaginal delivery, operative vaginal delivery (forceps), or cesarean section

Duration from induction of labor to delivery (hours)

Number of participants in the intervention group (Group I) who received intravenous oxytocin during the induction process

Number of participants who experienced uterine hyperstimulation, defined as more than 5 uterine contractions in 10 minutes over a minimal period of two consecutive 10-minute intervals, and/or a single uterine contraction lasting more than 3 minutes with fetal heart rate changes

Maternal satisfaction, assessed using a 5-point Likert scale, where 1 indicates very dissatisfied and 5 indicates very satisfied

Number of participants who experienced postpartum haemorrhage, defined as estimated blood loss greater than 500 mL after vaginal birth or greater than 1000 mL after caesarean birth within 24 hours after delivery

Number of participants with uterine rupture

Number of participants who underwent hysterectomy for any complication resulting from childbirth

Number of participants with maternal infection, defined as the presence of at least one of the following criterias:

Fever (defined as a temperature ≥38.0 degrees Celsius). Start of intravenous broad-spectrum antibiotics (with evidence of infection confirmed by clinical and subclinical presentation).

Endometritis, myometritis or urinary tract infection (proven positive vaginal discharge/urine culture).

Number of participants with injury to internal organs, including intestines, bladder, or ureters, diagnosed clinically and/or confirmed intraoperatively during delivery or postpartum care.

Number of participants admitted to the intensive care unit

Number of participants who experienced cardiorespiratory arrest

Number of participants diagnosed with pulmonary embolism

Number of participants diagnosed with stroke

Number of participants who died from any cause between randomization and maternal hospital discharge

Duration of stay in hospital (days)

Number of neonates with birth trauma, defined as the presence of at least one birth-related traumatic injury, including bone fracture, traumatic pneumothorax, facial nerve palsy, brachial plexus injury, or other clinically diagnosed birth-related trauma, identified by clinical examination and/or imaging during the neonatal hospital stay

Number of neonates with hypoxic ischemic encephalopathy or need for therapeutic hypothermia

Number of neonates diagnosed with meconium aspiration syndrome, defined by the presence of:

Meconium-stained amniotic fluid Respiratory distress at birth or shortly after birth Characteristic radiographic features: The initial chest film may show streaky, linear densities -> the lungs typically appear hyper-inflated with flattening of the diaphragms.

Number of neonates requiring respiratory support, defined as the use of one or more of the following interventions within the first 72 hours after birth: Endotracheal intubation; Continuous Positive Airway Pressure (CPAP); High-flow nasal cannula (HFNC); Use of respiratory support as part of ventilation or cardiopulmonary resuscitation.

Number of neonates diagnosed with neonatal infection, defined as meeting at least one of the following criteria:

Presence of a clinically ill neonate in whom systemic infection is suspected and confirmed by a positive blood culture, cerebrospinal fluid (CSF) culture, or catheterized/suprapubic urine culture; Or, in the absence of positive cultures, clinical evidence of cardiovascular collapse consistent with infection; Or radiographic evidence (e.g., chest X-ray) confirming infection.

Number of neonates with neonatal seizures

Number of neonates who died during the intrapartum period, neonatal period, or perinatal period

Number of neonates admitted to the neonatal unit

Number of participants delivered vaginally within 12 hours

Number of participants who developed regular uterine contractions accompanied by cervical dilation of ≥5 cm, as assessed by a qualified obstetric provider

Duration from induction to dinoprostone vaginal insert removal (hours). Applicable to participants in the dinoprostone insert arm only

Duration from induction to active phase of labor (hours)

Duration from the first confirmed rupture of membranes (either by maternal report of clear fluid leakage or clinical diagnosis) to the initiation of labor induction (hours)

Duration from the first confirmed rupture of membranes (either by maternal report of clear fluid leakage or clinical diagnosis) to delivery (hours).

Time interval (in hours) from the first dose of intravenous intrapartum antibiotic prophylaxis to delivery

Number of participants with meconium-stained amniotic fluid, defined as the presence of meconium in the amniotic fluid, as documented by clinical staff during labor or at delivery

Number of participants who required tocolytic treatment due to excessive uterine activity during labor induction

Number of participants experiencing maternal side effects related to labor induction, including nausea, vomiting, diarrhea, or other gastrointestinal symptoms

Number of participants who received any form of analgesia during labor, including epidural analgesia, systemic opioids (e.g., fentanyl), or other pharmacological pain relief methods

Number of participants having maternal post-partum blood transfusion

Number of participants with uterine atony requiring treatment with two or more uterotonic agents other than oxytocin and/or additional interventions, including manual uterine compression, compression sutures, uterine artery ligation, embolization, hypogastric artery ligation, or balloon tamponade

Number of participants who underwent hysterectomy for any postpartum complication

Number of participants with Group B Streptococcus (GBS) colonization, defined as a positive screening test for Streptococcus agalactiae during the late third trimester

Maternal overall pain experienced during labor, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable

Number of participants with at least one of the following maternal complications: chorioamnionitis, postpartum hemorrhage, intensive care unit admission, hysterectomy, uterine rupture, cervical tear, or maternal death

Apgar score assessed at 1 minute after birth

Apgar score assessed at 5-minute after birth

Number of neonates with an Apgar score of 7 or less at 1 or 5-minute after birth

Number of neonates admitted to the Neonatal Intensive Care Unit (NICU)

Reason for Neonatal Intensive Care Unit admission such as: respiratory distress, hypoglycemia, seizures, etc..

Duration from admission to Neonatal Intensive Care Unit to Neonatal Intensive Care Unit discharge or hospital referral

Number of neonates with hypoglycemia

Number of neonates diagnosed with jaundice and hyperbilirubinemia during the neonatal hospital stay

Number of neonates diagnosed with intracranial hemorrhage, defined as any bleeding within the cranial vault confirmed by clinical assessment and/or imaging studies, including intraventricular hemorrhage, subdural hemorrhage, subarachnoid hemorrhage, or subgaleal hemorrhage

Number of neonates who received blood transfusion during the neonatal hospital stay

Number of neonates referred to another hospital due to severe neonatal complications

Number of neonates experiencing at least one of the following events: low Apgar score, prematurity, neonatal intensive care unit admission, neonatal infection, neonatal seizures, respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, or perinatal death