Induction of labor is one of the most common interventions in obstetrics. In the past decade, the rates of labor induction at term have doubled from approximately 9% to 23% in the United States and from 10% to 20.4% in China. The majority of women undergoing labor induction requires cervical ripening for the unfavorable cervixes. As globally, it is still required to explore an optimal induction method. Foley catheter was among the oldest mechanical approaches, while prostaglandin E2 vaginal suppository (PGE2) one of the most popular pharmacological agents for cervical ripening. There were studies reporting similar cesarean section rates between these two methods. However, there are no randomized control trials (RCTs) with adequate power to compare their frequencies of severe perinatal complications. The investigators aim to compare the effectiveness and safety of Foley catheter versus PGE2 for induction of labor among term pregnant women with an unfavourable cervix.
The investigators propose a single center, open-label, randomized controlled clinical trial (1:1 treatment ratio) in Guangzhou Women and Children's Medical Center. Women with a term pregnancy, an indication for induction of labor, and a live singleton fetus at cephalic presentation, intact membranes, an unfavorable cervix, no prior cesarean section or contraindication to vaginal delivery, are eligible to participate. After informed consent, they will be randomized to undergo induction of labor by Foley catheter or PGE2. Our primary outcomes will be (I) a composite of severe perinatal complications and (II) vaginal delivery. Before the formal recruitment of this RCT, a pilot study with a sample size of 200 pregnant women will be performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
A Foley catheter will be introduced transcervically in women allocated in this group, with the aid of a vaginal speculum after cervical cleaning with an aseptic solution. The balloon will be inflated with 60 mL of sterile 0.9%% sodium chloride (NaCl) after insertion past the internal os. The external end of the catheter is taped to the inner thigh without applying any traction or tension.
PGE2 (1mg) will be inserted into the posterior vaginal fornix. Women will be assigned one hour of bed rest while continuously monitored by cardiotocography.
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
Number of cases with perinatal complications
This primary outcome will be a composite of cases with severe perinatal complications and consists of one or more of the following: need for respiratory support within hours after birth, Apgar score \< 7 at 1 minutes, Apgar score \<7 at 5 minutes, umbilical cord arterial potential of hydrogen (pH ) \< 7.10, birth trauma (including bone fracture, neurologic injury, or retinal hemorrhage), hypoxic-ischemic encephalopathy or need for therapeutic hypothermia, seizure, pneumonia, meconium aspiration syndrome, neonatal meningitis, neonatal sepsis, infant respiratory distress syndrome, pneumothorax or pneumomediastinum, apnoea, necrotising enterocolitis, clinical diagnosis of asphyxia, intraventricular haemorrhage, perinatal death (fetal or neonatal death occurring during childbirth, or up to 7 completed days after birth) or admission to the neonatal intensive care unit (NICU) for \>48 hours. Each component of this outcome is described from outcome 3 to outcome 21.
Time frame: Up to 3 weeks
Percentage of vaginal delivery
The co-primary outcome is vaginal delivery.
Time frame: Up to 1 week
Number of neonates need for respiratory support
Respiratory support within hours after birth
Time frame: Up to 1 week
Number of neonates with Apgar score < 7 at 1 minutes
Apgar scores of less than 7 at 1 min
Time frame: On the day of delivery
Number of neonates with Apgar score < 7 at 5 minutes
Apgar scores of less than 7 at 5 min
Time frame: On the day of delivery
Number of neonates with umbilical cord arterial pH < 7.10
An assay of arterial cord blood pH of less than 7.10
Time frame: On the day of delivery
Number of neonates with birth trauma
Birth trama including bone fracture, neurologic injury, or retinal hemorrhage
Time frame: Up to 1 week
Number of neonates with hypoxic-ischemic encephalopathy or need for therapeutic hypothermia
Neonates diagnosed with hypoxic-ischemic encephalopathy or require therapeutic hypothermia
Time frame: Up to 1 week
Number of neonates with pneumonia
Pneumonia revealed by physical examination, blood test and image
Time frame: Up to 2 weeks
Number of neonates with seizure
Clinical signs of seizure
Time frame: Up to 2 weeks
Number of neonates with meconium aspiration syndrome
Diagnosed according to clinical symptoms, blood test and image
Time frame: Up to 2 week
Number of neonates with neonatal meningitis
Diagnosed by blood and cerebrospinal fluid test and image
Time frame: Up to 4 weeks
Number of neonates with neonatal sepsis
Diagnosed by clinical symptoms, blood test and bacterial culture
Time frame: Up to 2 weeks
Number of neonates with infant respiratory distress syndrome
Diagnosed by blood test and image
Time frame: Up to 2 weeks
Number of neonates with infant pneumothorax or pneumomediastinum
Diagnosed by thorax image
Time frame: Up to 2 weeks
Number of neonates with apnoea
Clinical diagnosis of apnoea
Time frame: Up to 2 weeks
Number of neonates with necrotising enterocolitis
Diagnosed by clinical symptoms, stool examination and image
Time frame: Up to 2 weeks
Number of neonates with clinical diagnosis of asphyxia
Clinical diagnosis of neonatal asphyxia
Time frame: Up to 2 weeks
Number of perinatal deaths
Fetal or neonatal death occurring during childbirth
Time frame: up to 2 weeks
Number of neonates with intraventricular hemorrhage
Intraventricular haemorrhage diagnosed by clinical symptoms and image
Time frame: Up to 2 week
Number of neonates admission to the NICU for >48 hours
Length of admission to the NICU for less than 48 hours
Time frame: up to 2 weeks
Number of cases with maternal secondary outcomes
This secondary outcome will be a composite of maternal complications and consists of one or more of the following: cardio-respiratory arrest, damage to internal organs (bowel, bladder or ureters), postpartum hemorrhage (estimated blood loss \>500 milliliter (mL) in the 24 hours after delivery), hysterectomy for any complications resulting from birth, intensive care admission, uterine rupture: separation of the uterine wall, maternal infection, pulmonary embolism, stroke, maternal satisfaction, maternal death. Each component of this outcome is described from outcome 23 to outcome 33.
Time frame: Up to 2 weeks
Number of mothers with cardio-respiratory arrest
Clinical diagnosis of cardio-respiratory arrest
Time frame: Up to 2 weeks
Number of mothers with damage to internal organs
Damage to internal organs, including bowel, bladder or ureters
Time frame: Up to 2 weeks
Number of mothers with postpartum hemorrhage
Postpartum hemorrhage is defined as estimated blood loss \>500 mL in the 24 hours after delivery
Time frame: Up to 1 week
Number of mothers have hysterectomy
Hysterectomy for any complications resulting from birth
Time frame: Up to 2 weeks
Number of mothers have intensive care admission
Admission of puerpera to ICU
Time frame: Up to 3 weeks
Number of mothers have uterine rupture
Uterine rupture refers to separation of the uterine wall
Time frame: Up to 2 weeks
Number of maternal infection
Maternal infection diagnosed by clinical symptoms, blood test, bacterial culture.
Time frame: Up to 2 weeks
Number of mothers have pulmonary embolism
Diagnosed by clinical symptoms, blood test and image
Time frame: Up to 2 weeks
Number of mothers have stroke
Diagnosed by clinical signs, blood test and cerebral image
Time frame: Up to 2 weeks
Scores of maternal satisfaction with the intervention of labor induction
Maternal satisfaction will be evaluated by a questionaire consisted of 11 questions scored on a 5-point Likert scale.
Time frame: Up to 2 weeks
Number of maternal death
Maternal death due to delivery
Time frame: Up to 2 weeks
Number of neonates with hyperbilirubinemia
Hyperbilirubinemia requiring photo-therapy or exchange transfusion
Time frame: Up to 2 weeks
Number of neonates with hypoglycemia
Hypoglycemia requiring intravenous therapy
Time frame: Up to 2 weeks
Length of neonatal admission (days)
Length of admission of neonate
Time frame: Up to 3 weeks
Number of neonates with cephalohematoma
Diagnosed by physical examination and image
Time frame: Up to 2 weeks
Number of neonates have shoulder dystocia
Diagnosed by physical examination and image
Time frame: Up to 1 week
Number of neonates have admission to the NICU < 48 hours
Admission of neonates to NICU for less than 48 hours
Time frame: Up to 1 week
Number of cases with indication of caesarean section
Indication of caesarean section including failure to progress at first stage, failure to progress at second stage, failed instrumental delivery, suspected fetal distress, suspected fetal distress and failure to progress at first stage, suspected fetal distress and failure to progress at second stage, and maternal complications or other
Time frame: Up to 1 week
Number of cases with indication of instrumental delivery
Indication of instrumental delivery including failure to progress at second stage, suspected fetal distress, suspected fetal distress and failure to progress at second stage, and maternal complications or other
Time frame: Up to 1 week
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