Foley Catheter Versus PGE2 for Labor Induction at Term: a Pilot Study
- Conditions
- Labor InductionInduced Delivery
- Interventions
- Device: Induction of labor with Foley catheterDrug: Induction of labor with PGE2
- Registration Number
- NCT04780269
- Lead Sponsor
- Guangzhou Women and Children's Medical Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- Female
- Target Recruitment
- 200
- Women scheduled for induction of labor.
- Women aged ≥ 18 years old
- ≥ 37 weeks of gestation
- Live singleton pregnancy in cephalic presentation
- Intact membranes
- Cervical Bishop score < 6
- Informed consent.
- Contraindications for vaginal delivery.
- Prior cesarean section
- Known hypersensitivity for Foley catheter or PGE2
- Non-reassuring fetal status
- Lethal fetal congenital anomaly
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Induction of labor with Foley catheter Induction of labor with Foley catheter A Foley catheter will be introduced transcervically in women allocated in this group. Induction of labor with PGE2 Induction of labor with PGE2 PGE2 (1mg) will be inserted into the posterior vaginal fornix.
- Primary Outcome Measures
Name Time Method Number of cases with perinatal complications Up to 3 weeks 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.
Percentage of vaginal delivery Up to 1 week The co-primary outcome is vaginal delivery.
- Secondary Outcome Measures
Name Time Method Number of neonates with Apgar score < 7 at 5 minutes On the day of delivery Apgar scores of less than 7 at 5 min
Number of neonates need for respiratory support Up to 1 week Respiratory support within hours after birth
Number of neonates with Apgar score < 7 at 1 minutes On the day of delivery Apgar scores of less than 7 at 1 min
Number of neonates with umbilical cord arterial pH < 7.10 On the day of delivery An assay of arterial cord blood pH of less than 7.10
Number of neonates with birth trauma Up to 1 week Birth trama including bone fracture, neurologic injury, or retinal hemorrhage
Number of neonates with hypoxic-ischemic encephalopathy or need for therapeutic hypothermia Up to 1 week Neonates diagnosed with hypoxic-ischemic encephalopathy or require therapeutic hypothermia
Number of neonates with seizure Up to 2 weeks Clinical signs of seizure
Number of neonates with meconium aspiration syndrome Up to 2 week Diagnosed according to clinical symptoms, blood test and image
Number of neonates with neonatal meningitis Up to 4 weeks Diagnosed by blood and cerebrospinal fluid test and image
Number of neonates with neonatal sepsis Up to 2 weeks Diagnosed by clinical symptoms, blood test and bacterial culture
Number of neonates with apnoea Up to 2 weeks Clinical diagnosis of apnoea
Number of neonates with necrotising enterocolitis Up to 2 weeks Diagnosed by clinical symptoms, stool examination and image
Number of neonates with pneumonia Up to 2 weeks Pneumonia revealed by physical examination, blood test and image
Number of neonates with infant respiratory distress syndrome Up to 2 weeks Diagnosed by blood test and image
Number of neonates with infant pneumothorax or pneumomediastinum Up to 2 weeks Diagnosed by thorax image
Number of neonates with clinical diagnosis of asphyxia Up to 2 weeks Clinical diagnosis of neonatal asphyxia
Number of perinatal deaths up to 2 weeks Fetal or neonatal death occurring during childbirth
Number of neonates with intraventricular hemorrhage Up to 2 week Intraventricular haemorrhage diagnosed by clinical symptoms and image
Number of neonates admission to the NICU for >48 hours up to 2 weeks Length of admission to the NICU for less than 48 hours
Number of cases with maternal secondary outcomes Up to 2 weeks 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.
Number of mothers with cardio-respiratory arrest Up to 2 weeks Clinical diagnosis of cardio-respiratory arrest
Number of mothers with damage to internal organs Up to 2 weeks Damage to internal organs, including bowel, bladder or ureters
Number of mothers with postpartum hemorrhage Up to 1 week Postpartum hemorrhage is defined as estimated blood loss \>500 mL in the 24 hours after delivery
Number of mothers have hysterectomy Up to 2 weeks Hysterectomy for any complications resulting from birth
Number of mothers have intensive care admission Up to 3 weeks Admission of puerpera to ICU
Number of mothers have uterine rupture Up to 2 weeks Uterine rupture refers to separation of the uterine wall
Number of maternal infection Up to 2 weeks Maternal infection diagnosed by clinical symptoms, blood test, bacterial culture.
Number of mothers have pulmonary embolism Up to 2 weeks Diagnosed by clinical symptoms, blood test and image
Number of mothers have stroke Up to 2 weeks Diagnosed by clinical signs, blood test and cerebral image
Scores of maternal satisfaction with the intervention of labor induction Up to 2 weeks Maternal satisfaction will be evaluated by a questionaire consisted of 11 questions scored on a 5-point Likert scale.
Number of maternal death Up to 2 weeks Maternal death due to delivery
Number of neonates with hyperbilirubinemia Up to 2 weeks Hyperbilirubinemia requiring photo-therapy or exchange transfusion
Number of neonates with hypoglycemia Up to 2 weeks Hypoglycemia requiring intravenous therapy
Length of neonatal admission (days) Up to 3 weeks Length of admission of neonate
Number of neonates with cephalohematoma Up to 2 weeks Diagnosed by physical examination and image
Number of neonates have shoulder dystocia Up to 1 week Diagnosed by physical examination and image
Number of neonates have admission to the NICU < 48 hours Up to 1 week Admission of neonates to NICU for less than 48 hours
Number of cases with indication of caesarean section Up to 1 week 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
Number of cases with indication of instrumental delivery Up to 1 week 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
Trial Locations
- Locations (1)
Guangzhou Women and Children's Medical Center
🇨🇳Guangzhou, Guangdong, China