Prostaglandins Versus Trans-cervical Balloon for Induction of Labor in Fetal Growth Restriction (PROBIN)

Mean duration of labor (duration between admission to the labor room and delivery)

Mean duration between cervical ripening and delivery

Incidence of oxytocin use (median of the maximal administered dosage)

Incidence of operative delivery (vacuum, forceps, spatula)

Incidence of postpartum hemorrhage defined by blood loss >500mL (defined according to the CNGOF criteria)

Mean total blood loss (mL)

Incidence of intra-uterine infectious defined by a fever (maternal temperature equal to or greater than 38°C twice), associated to at least one of the two criterion: persistent fetal tachycardia > 160 bpm, or purulent amniotic fluid (defined according to the CNGOF criteria).

Incidence of postpartum intravenous iron administration

Incidence of transfusion of blood products or blood

Incidence of maternal thromboembolism event (deep venous thrombosis diagnosed using leg Doppler ultrasound or pulmonary embolism diagnosed using computed tomographic pulmonary angiography)

Incidence of maternal satisfaction with a satisfaction questionnaire derived from the childbirth experience questionnaire and satisfaction questionnaire of TRAAP2 study

Mean duration of hospitalization

Incidence of umbilical artery lactic acid greater than 10mmol/l

Incidence of umbilical artery pH of less than 7,05

Incidence of neonatal 5 minutes Apgar Score of less than 7

Incidence of neonatal hypoglycemia (blood glucose < 35 mg/L) requiring intravenous therapy

Incidence of admission to neonatal intensive care unit or intermediate care unit

Mean neonatal length of hospital stay

Incidence of neonatal death before discharge

Incidence of non-reassuring fetal status occurring after the beginning of the cervical ripening (including both cervical ripening and labor). Non-reassuring fetal status is defined by the Fédération Internationale de Gynécologie et d'Obstétrique (FIGO), who class the CTG tracing in 3 class: normal, suspicious and pathological 3. According to this classification, non-reassuring fetal status is defined as the presence of a suspicious or pathological CTG tracings, predictive of hypoxia/ neonatal acidosis status

Incidence of cesarean section for non-reassuring fetal status

Incidence of cesarean section for arrest of labor

Incidence of the need for neonatal ventilation in the first 72 hours of life, defined by intubation, continuous positive airway pressure (CPAP) or high-flow nasal cannula

Incidence of neonatal hypoxic-ischemic encephalopathy

Incidence of neonatal seizure

Incidence of neonatal infection (confirmed sepsis or pneumonia)

Incidence of neonatal meconium aspiration syndrome,

Incidence of birth trauma (bone fracture, neurologic injury, or retinal hemorrhage),

Incidence of neonatal intracranial or subgaleal hemorrhage,

Incidence of neonatal arterial hypotension requiring pressor support

Defined by a score greater than 13 on the EPDS (Edinburgh Postpartum Depression Scale). The EPDS scale calculates a depressive symptom score ranging from 0 (no depression symptoms) to 30 (severe depression symptoms). Threshold values greater than 13 are used to identify women at high risk for postpartum depression.

Defined by a score greater than 33 on the IES-R (Impact of Event Scale - Revised) questionnaire or by the presence of all criteria from the DSM-IV (4th edition of the Diagnostic and Statistical Manual of Mental Disorders) (criteria A, B, C, D, E, and F) on the TES (Traumatic Event Scale). The IES-R measures the severity of PTSD symptoms over the past 7 days, with scores ranging from 0 (no PTSD symptoms) to 88 (extreme PTSD symptoms). The diagnosis of PTSD is made when the IES-R score is greater than 33.

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