Clinical trial NCT04780269: Foley Catheter Versus PGE2 for Labor Induction at Term: a Pilot Study
Official title: Foley Catheter Versus Prostaglandin E2 Vaginal Suppository for Labor Induction at Term: a Pilot Study
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE4
Conditions: Labor Induction
Induced Delivery
Keywords: Labor induction
Term delivery with an unfavorable cervix
Foley catheter
Prostaglandin E2
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Contraindications for vaginal delivery.
* Prior cesarean section
* Known hypersensitivity for Foley catheter or PGE2
* Non-reassuring fetal status
* Lethal fetal congenital anomaly

Primary outcomes:
measure: Number of cases with perinatal complications
timeFrame: Up to 3 weeks
measure: Percentage of vaginal delivery
timeFrame: Up to 1 week
Secondary outcomes:
measure: Number of neonates need for respiratory support
timeFrame: Up to 1 week
measure: Number of neonates with Apgar score < 7 at 1 minutes
timeFrame: On the day of delivery
measure: Number of neonates with Apgar score < 7 at 5 minutes
timeFrame: On the day of delivery
measure: Number of neonates with umbilical cord arterial pH < 7.10
timeFrame: On the day of delivery
measure: Number of neonates with birth trauma
timeFrame: Up to 1 week
measure: Number of neonates with hypoxic-ischemic encephalopathy or need for therapeutic hypothermia
timeFrame: Up to 1 week
measure: Number of neonates with pneumonia
timeFrame: Up to 2 weeks
measure: Number of neonates with seizure
timeFrame: Up to 2 weeks
measure: Number of neonates with meconium aspiration syndrome
timeFrame: Up to 2 week
measure: Number of neonates with neonatal meningitis
timeFrame: Up to 4 weeks
measure: Number of neonates with neonatal sepsis
timeFrame: Up to 2 weeks
measure: Number of neonates with infant respiratory distress syndrome
timeFrame: Up to 2 weeks
measure: Number of neonates with infant pneumothorax or pneumomediastinum
timeFrame: Up to 2 weeks
measure: Number of neonates with apnoea
timeFrame: Up to 2 weeks
measure: Number of neonates with necrotising enterocolitis
timeFrame: Up to 2 weeks
measure: Number of neonates with clinical diagnosis of asphyxia
timeFrame: Up to 2 weeks
measure: Number of perinatal deaths
timeFrame: up to 2 weeks
measure: Number of neonates with intraventricular hemorrhage
timeFrame: Up to 2 week
measure: Number of neonates admission to the NICU for >48 hours
timeFrame: up to 2 weeks
measure: Number of cases with maternal secondary outcomes
timeFrame: Up to 2 weeks
measure: Number of mothers with cardio-respiratory arrest
timeFrame: Up to 2 weeks
measure: Number of mothers with damage to internal organs
timeFrame: Up to 2 weeks
measure: Number of mothers with postpartum hemorrhage
timeFrame: Up to 1 week
measure: Number of mothers have hysterectomy
timeFrame: Up to 2 weeks
measure: Number of mothers have intensive care admission
timeFrame: Up to 3 weeks
measure: Number of mothers have uterine rupture
timeFrame: Up to 2 weeks
measure: Number of maternal infection
timeFrame: Up to 2 weeks
measure: Number of mothers have pulmonary embolism
timeFrame: Up to 2 weeks
measure: Number of mothers have stroke
timeFrame: Up to 2 weeks
measure: Scores of maternal satisfaction with the intervention of labor induction
timeFrame: Up to 2 weeks
measure: Number of maternal death
timeFrame: Up to 2 weeks
measure: Number of neonates with hyperbilirubinemia
timeFrame: Up to 2 weeks
measure: Number of neonates with hypoglycemia
timeFrame: Up to 2 weeks
measure: Length of neonatal admission (days)
timeFrame: Up to 3 weeks
measure: Number of neonates with cephalohematoma
timeFrame: Up to 2 weeks
measure: Number of neonates have shoulder dystocia
timeFrame: Up to 1 week
measure: Number of neonates have admission to the NICU < 48 hours
timeFrame: Up to 1 week
measure: Number of cases with indication of caesarean section
timeFrame: Up to 1 week
measure: Number of cases with indication of instrumental delivery
timeFrame: Up to 1 week
Other outcomes:
measure: Number of cases with suspected intrapartum infection
timeFrame: Up to 1 week
measure: Number of cases with uterine hyperstimulation
timeFrame: Up to 1 week
Locations:
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center
state: Guangdong
Study officials:
affiliation: Guangzhou Women and Children's Medical Center
name: JinYing Yang, MD.
role: PRINCIPAL_INVESTIGATOR
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