Foley Catheter Versus PGE2 for Labor Induction at Term: a Pilot Study

Foley Catheter Versus Prostaglandin E2 Vaginal Suppository for Labor Induction at Term: a Pilot Study

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.

Study Overview

• Status: Suspended
• Conditions: Labor Induction; Induced Delivery
• Intervention / Treatment: Device: Induction of labor with Foley catheter; Drug: Induction of labor with PGE2

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510623
      • Guangzhou Women and Children's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Induction of labor with Foley catheter; A Foley catheter will be introduced transcervically in women allocated in this group.	Device: Induction of labor with Foley catheter; 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.; Other Names: Foley Catheter
Experimental: Induction of labor with PGE2; PGE2 (1mg) will be inserted into the posterior vaginal fornix.	Drug: Induction of labor with PGE2; PGE2 (1mg) will be inserted into the posterior vaginal fornix. Women will be assigned one hour of bed rest while continuously monitored by cardiotocography.; Other Names: Dinoprostone suppositories

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 3 weeks
Percentage of vaginal delivery	The co-primary outcome is vaginal delivery.	Up to 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of neonates need for respiratory support	Respiratory support within hours after birth	Up to 1 week
Number of neonates with Apgar score < 7 at 1 minutes	Apgar scores of less than 7 at 1 min	On the day of delivery
Number of neonates with Apgar score < 7 at 5 minutes	Apgar scores of less than 7 at 5 min	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	On the day of delivery
Number of neonates with birth trauma	Birth trama including bone fracture, neurologic injury, or retinal hemorrhage	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	Up to 1 week
Number of neonates with pneumonia	Pneumonia revealed by physical examination, blood test and image	Up to 2 weeks
Number of neonates with seizure	Clinical signs of seizure	Up to 2 weeks
Number of neonates with meconium aspiration syndrome	Diagnosed according to clinical symptoms, blood test and image	Up to 2 week
Number of neonates with neonatal meningitis	Diagnosed by blood and cerebrospinal fluid test and image	Up to 4 weeks
Number of neonates with neonatal sepsis	Diagnosed by clinical symptoms, blood test and bacterial culture	Up to 2 weeks
Number of neonates with infant respiratory distress syndrome	Diagnosed by blood test and image	Up to 2 weeks
Number of neonates with infant pneumothorax or pneumomediastinum	Diagnosed by thorax image	Up to 2 weeks
Number of neonates with apnoea	Clinical diagnosis of apnoea	Up to 2 weeks
Number of neonates with necrotising enterocolitis	Diagnosed by clinical symptoms, stool examination and image	Up to 2 weeks
Number of neonates with clinical diagnosis of asphyxia	Clinical diagnosis of neonatal asphyxia	Up to 2 weeks
Number of perinatal deaths	Fetal or neonatal death occurring during childbirth	up to 2 weeks
Number of neonates with intraventricular hemorrhage	Intraventricular haemorrhage diagnosed by clinical symptoms and image	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	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.	Up to 2 weeks
Number of mothers with cardio-respiratory arrest	Clinical diagnosis of cardio-respiratory arrest	Up to 2 weeks
Number of mothers with damage to internal organs	Damage to internal organs, including bowel, bladder or ureters	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	Up to 1 week
Number of mothers have hysterectomy	Hysterectomy for any complications resulting from birth	Up to 2 weeks
Number of mothers have intensive care admission	Admission of puerpera to ICU	Up to 3 weeks
Number of mothers have uterine rupture	Uterine rupture refers to separation of the uterine wall	Up to 2 weeks
Number of maternal infection	Maternal infection diagnosed by clinical symptoms, blood test, bacterial culture.	Up to 2 weeks
Number of mothers have pulmonary embolism	Diagnosed by clinical symptoms, blood test and image	Up to 2 weeks
Number of mothers have stroke	Diagnosed by clinical signs, blood test and cerebral image	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.	Up to 2 weeks
Number of maternal death	Maternal death due to delivery	Up to 2 weeks
Number of neonates with hyperbilirubinemia	Hyperbilirubinemia requiring photo-therapy or exchange transfusion	Up to 2 weeks
Number of neonates with hypoglycemia	Hypoglycemia requiring intravenous therapy	Up to 2 weeks
Length of neonatal admission (days)	Length of admission of neonate	Up to 3 weeks
Number of neonates with cephalohematoma	Diagnosed by physical examination and image	Up to 2 weeks
Number of neonates have shoulder dystocia	Diagnosed by physical examination and image	Up to 1 week
Number of neonates have admission to the NICU < 48 hours	Admission of neonates to NICU for less than 48 hours	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	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	Up to 1 week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of cases with suspected intrapartum infection	Temperature ≥ 38°C during labor and/or use of broad-spectrum antibiotics due to suspected infection	Up to 1 week
Number of cases with uterine hyperstimulation	Single contractions lasting 2 minutes or more, or five or more contractions in a 10 minutes period more than one induction agent required	Up to 1 week

Collaborators and Investigators

• Sponsor: Guangzhou Women and Children's Medical Center
• Investigators: Principal Investigator: JinYing Yang, MD., Guangzhou Women and Children's Medical Center

Publications and helpful links

General Publications

• Grobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, El-Sayed YY, Perez-Delboy A, Rouse DJ, Saade GR, Boggess KA, Chauhan SP, Iams JD, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. N Engl J Med. 2018 Aug 9;379(6):513-523. doi: 10.1056/NEJMoa1800566.
• Saad AF, Villarreal J, Eid J, Spencer N, Ellis V, Hankins GD, Saade GR. A randomized controlled trial of Dilapan-S vs Foley balloon for preinduction cervical ripening (DILAFOL trial). Am J Obstet Gynecol. 2019 Mar;220(3):275.e1-275.e9. doi: 10.1016/j.ajog.2019.01.008. Epub 2019 Feb 18.
• Ten Eikelder ML, Oude Rengerink K, Jozwiak M, de Leeuw JW, de Graaf IM, van Pampus MG, Holswilder M, Oudijk MA, van Baaren GJ, Pernet PJ, Bax C, van Unnik GA, Martens G, Porath M, van Vliet H, Rijnders RJ, Feitsma AH, Roumen FJ, van Loon AJ, Versendaal H, Weinans MJ, Woiski M, van Beek E, Hermsen B, Mol BW, Bloemenkamp KW. Induction of labour at term with oral misoprostol versus a Foley catheter (PROBAAT-II): a multicentre randomised controlled non-inferiority trial. Lancet. 2016 Apr 16;387(10028):1619-28. doi: 10.1016/S0140-6736(16)00084-2. Epub 2016 Feb 3.
• Martin JA, Hamilton BE, Sutton PD, Ventura SJ, Mathews TJ, Osterman MJ. Births: final data for 2008. Natl Vital Stat Rep. 2010 Dec 8;59(1):1, 3-71.
• Jozwiak M, Oude Rengerink K, Benthem M, van Beek E, Dijksterhuis MG, de Graaf IM, van Huizen ME, Oudijk MA, Papatsonis DN, Perquin DA, Porath M, van der Post JA, Rijnders RJ, Scheepers HC, Spaanderman ME, van Pampus MG, de Leeuw JW, Mol BW, Bloemenkamp KW; PROBAAT Study Group. Foley catheter versus vaginal prostaglandin E2 gel for induction of labour at term (PROBAAT trial): an open-label, randomised controlled trial. Lancet. 2011 Dec 17;378(9809):2095-103. doi: 10.1016/S0140-6736(11)61484-0. Epub 2011 Oct 24.
• Dos Santos F, Drymiotou S, Antequera Martin A, Mol BW, Gale C, Devane D, Van't Hooft J, Johnson MJ, Hogg M, Thangaratinam S. Development of a core outcome set for trials on induction of labour: an international multistakeholder Delphi study. BJOG. 2018 Dec;125(13):1673-1680. doi: 10.1111/1471-0528.15397. Epub 2018 Sep 10.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 3, 2021

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Labor induction; Foley catheter; Prostaglandin E2; Term delivery with an unfavorable cervix
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Dinoprostone
• Other Study ID Numbers: [2020]31201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No