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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction of labor with Foley catheter | Experimental | A Foley catheter will be introduced transcervically in women allocated in this group. |
|
| Induction of labor with PGE2 | Experimental | PGE2 (1mg) will be inserted into the posterior vaginal fornix. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Induction of labor with Foley catheter | Device | 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JinYing Yang, MD. | Guangzhou Women and Children's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou Women and Children's Medical Center | Guangzhou | Guangdong | 510623 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22145497 | Background | 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. | |
| 30089070 | Background | 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. |
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| ID | Term |
|---|---|
| D007751 | Labor, Induced |
| D015232 | Dinoprostone |
| ID | Term |
|---|---|
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D011458 | Prostaglandins E |
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|
| Induction of labor with PGE2 | Drug | PGE2 (1mg) will be inserted into the posterior vaginal fornix. Women will be assigned one hour of bed rest while continuously monitored by cardiotocography. |
|
|
| 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 |
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 |
| 22030144 | Background | 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. |
| 30790569 | Background | 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. |
| 29981523 | Background | 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. |
| 26850983 | Background | 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. |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |