Labor InductionPhase 4NCT04780269
Foley Catheter Versus PGE2 for Labor Induction at Term: a Pilot Study
A Phase 4 study testing Induction of labor with Foley catheter and Induction of labor with PGE2 in people with Labor Induction and Induced Delivery, run by Guangzhou Women and Children's Medical Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Induction, Induced Delivery
- What is being tested?
- Induction of labor with Foley catheter and Induction of labor with PGE2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Dec 2023to Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Contraindications for vaginal delivery.
- Prior cesarean section
- Known hypersensitivity for Foley catheter or PGE2
- Non-reassuring fetal status
- Lethal fetal congenital anomaly
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, 510623
About this study
Official title: 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.
Read the 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.
- Conditions
- Labor Induction, Induced Delivery
- Being tested
- Induction of labor with Foley catheter, Induction of labor with PGE2
- Keywords
- Labor induction, Term delivery with an unfavorable cervix, Foley catheter, Prostaglandin E2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction of labor with Foley catheterDevice
Also called 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.
Induction of labor with PGE2Drug
Also called Dinoprostone suppositories
PGE2 (1mg) will be inserted into the posterior vaginal fornix. Women will be assigned one hour of bed rest while continuously monitored by cardiotocography.
| Study group | Role | What they receive |
|---|---|---|
| Induction of labor with Foley catheter | Experimental | A Foley catheter will be introduced transcervically in women allocated in this group. Receives: Device: Induction of labor with Foley catheter |
| Induction of labor with PGE2 | Experimental | PGE2 (1mg) will be inserted into the posterior vaginal fornix. Receives: Drug: Induction of labor with PGE2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 weeks
Percentage of vaginal delivery
The co-primary outcome is vaginal delivery.
Measured: Up to 1 week
Secondary outcomes (39)
Number of neonates need for respiratory support
Respiratory support within hours after birth
Measured: Up to 1 week
Number of neonates with Apgar score < 7 at 1 minutes
Apgar scores of less than 7 at 1 min
Measured: On the day of delivery
Number of neonates with Apgar score < 7 at 5 minutes
Apgar scores of less than 7 at 5 min
Measured: 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
Measured: On the day of delivery
Number of neonates with birth trauma
Birth trama including bone fracture, neurologic injury, or retinal hemorrhage
Measured: 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
Measured: Up to 1 week
Number of neonates with pneumonia
Pneumonia revealed by physical examination, blood test and image
Measured: Up to 2 weeks
Number of neonates with seizure
Clinical signs of seizure
Measured: Up to 2 weeks
Number of neonates with meconium aspiration syndrome
Diagnosed according to clinical symptoms, blood test and image
Measured: Up to 2 week
Number of neonates with neonatal meningitis
Diagnosed by blood and cerebrospinal fluid test and image
Measured: Up to 4 weeks
Number of neonates with neonatal sepsis
Diagnosed by clinical symptoms, blood test and bacterial culture
Measured: Up to 2 weeks
Number of neonates with infant respiratory distress syndrome
Diagnosed by blood test and image
Measured: Up to 2 weeks
Number of neonates with infant pneumothorax or pneumomediastinum
Diagnosed by thorax image
Measured: Up to 2 weeks
Number of neonates with apnoea
Clinical diagnosis of apnoea
Measured: Up to 2 weeks
Number of neonates with necrotising enterocolitis
Diagnosed by clinical symptoms, stool examination and image
Measured: Up to 2 weeks
Number of neonates with clinical diagnosis of asphyxia
Clinical diagnosis of neonatal asphyxia
Measured: Up to 2 weeks
Number of perinatal deaths
Fetal or neonatal death occurring during childbirth
Measured: up to 2 weeks
Number of neonates with intraventricular hemorrhage
Intraventricular haemorrhage diagnosed by clinical symptoms and image
Measured: 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
Measured: 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.
Measured: Up to 2 weeks
Number of mothers with cardio-respiratory arrest
Clinical diagnosis of cardio-respiratory arrest
Measured: Up to 2 weeks
Number of mothers with damage to internal organs
Damage to internal organs, including bowel, bladder or ureters
Measured: 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
Measured: Up to 1 week
Number of mothers have hysterectomy
Hysterectomy for any complications resulting from birth
Measured: Up to 2 weeks
Number of mothers have intensive care admission
Admission of puerpera to ICU
Measured: Up to 3 weeks
Number of mothers have uterine rupture
Uterine rupture refers to separation of the uterine wall
Measured: Up to 2 weeks
Number of maternal infection
Maternal infection diagnosed by clinical symptoms, blood test, bacterial culture.
Measured: Up to 2 weeks
Number of mothers have pulmonary embolism
Diagnosed by clinical symptoms, blood test and image
Measured: Up to 2 weeks
Number of mothers have stroke
Diagnosed by clinical signs, blood test and cerebral image
Measured: 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.
Measured: Up to 2 weeks
Number of maternal death
Maternal death due to delivery
Measured: Up to 2 weeks
Number of neonates with hyperbilirubinemia
Hyperbilirubinemia requiring photo-therapy or exchange transfusion
Measured: Up to 2 weeks
Number of neonates with hypoglycemia
Hypoglycemia requiring intravenous therapy
Measured: Up to 2 weeks
Length of neonatal admission (days)
Length of admission of neonate
Measured: Up to 3 weeks
Number of neonates with cephalohematoma
Diagnosed by physical examination and image
Measured: Up to 2 weeks
Number of neonates have shoulder dystocia
Diagnosed by physical examination and image
Measured: Up to 1 week
Number of neonates have admission to the NICU < 48 hours
Admission of neonates to NICU for less than 48 hours
Measured: 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
Measured: 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
Measured: Up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study startDec 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: understaffed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Labor InductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehong Zhou, Guangzhou Women and Children's Medical Center
- Investigators
- JinYing Yang, MD., Principal investigator, Guangzhou Women and Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780269
- Sponsor's protocol ID
- [2020]31201
- Status last verified
- Sep 2023
- First submitted
- 22 Feb 2021
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22145497Grobman 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.
PubMed 30089070Jozwiak 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.
PubMed 22030144Saad 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.
PubMed 30790569Dos 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.
PubMed 29981523Ten 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.
PubMed 26850983
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foley Catheter Versus Prostaglandin E2 Vaginal Suppository for Labor Induction at Term: a Pilot Study
- ClinicalTrials.gov ID
- NCT04780269
- Acronym / sponsor ID
- [2020]31201
- Conditions
- Labor Induction, Induced Delivery
- Keywords
- Labor induction, Term delivery with an unfavorable cervix, Foley catheter, Prostaglandin E2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: understaffed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Induction of labor with Foley catheter | Experimental | Device: Induction of labor with Foley catheterA Foley catheter will be introduced transcervically in women allocated in this group. |
| Induction of labor with PGE2 | Experimental | Drug: Induction of labor with PGE2PGE2 (1mg) will be inserted into the posterior vaginal fornix. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women scheduled for induction of labor.
- Women aged ≥ 18 years old
- ≥ 37 weeks of gestation
- Live singleton pregnancy in cephalic presentation
- Intact membranes
Key exclusion criteria (5 listed)
- Contraindications for vaginal delivery.
- Prior cesarean section
- Known hypersensitivity for Foley catheter or PGE2
- Non-reassuring fetal status
- Lethal fetal congenital anomaly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Induction of labor with Foley catheterAlso: Foley CatheterA 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. | Device | Induction of labor with Foley catheter |
| Induction of labor with PGE2Also: Dinoprostone suppositoriesPGE2 (1mg) will be inserted into the posterior vaginal fornix. Women will be assigned one hour of bed rest while continuously monitored by cardiotocography. | Drug | Induction of labor with PGE2 |
Primary outcome
Number of cases with perinatal complications
Time frame: 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
Time frame: Up to 1 week
The co-primary outcome is vaginal delivery.
39 secondary outcomes
Number of neonates need for respiratory support
Time frame: Up to 1 week
Number of neonates with Apgar score < 7 at 1 minutes
Time frame: On the day of delivery
Number of neonates with Apgar score < 7 at 5 minutes
Time frame: On the day of delivery
Number of neonates with umbilical cord arterial pH < 7.10
Time frame: On the day of delivery
Number of neonates with birth trauma
Time frame: Up to 1 week
Number of neonates with hypoxic-ischemic encephalopathy or need for therapeutic hypothermia
Time frame: Up to 1 week
Number of neonates with pneumonia
Time frame: Up to 2 weeks
Number of neonates with seizure
Time frame: Up to 2 weeks
Number of neonates with meconium aspiration syndrome
Time frame: Up to 2 week
Number of neonates with neonatal meningitis
Time frame: Up to 4 weeks
Number of neonates with neonatal sepsis
Time frame: Up to 2 weeks
Number of neonates with infant respiratory distress syndrome
Time frame: Up to 2 weeks
Number of neonates with infant pneumothorax or pneumomediastinum
Time frame: Up to 2 weeks
Number of neonates with apnoea
Time frame: Up to 2 weeks
Number of neonates with necrotising enterocolitis
Time frame: Up to 2 weeks
Number of neonates with clinical diagnosis of asphyxia
Time frame: Up to 2 weeks
Number of perinatal deaths
Time frame: up to 2 weeks
Number of neonates with intraventricular hemorrhage
Time frame: Up to 2 week
Number of neonates admission to the NICU for >48 hours
Time frame: up to 2 weeks
Number of cases with maternal secondary outcomes
Time frame: Up to 2 weeks
Number of mothers with cardio-respiratory arrest
Time frame: Up to 2 weeks
Number of mothers with damage to internal organs
Time frame: Up to 2 weeks
Number of mothers with postpartum hemorrhage
Time frame: Up to 1 week
Number of mothers have hysterectomy
Time frame: Up to 2 weeks
Number of mothers have intensive care admission
Time frame: Up to 3 weeks
Number of mothers have uterine rupture
Time frame: Up to 2 weeks
Number of maternal infection
Time frame: Up to 2 weeks
Number of mothers have pulmonary embolism
Time frame: Up to 2 weeks
Number of mothers have stroke
Time frame: Up to 2 weeks
Scores of maternal satisfaction with the intervention of labor induction
Time frame: Up to 2 weeks
Number of maternal death
Time frame: Up to 2 weeks
Number of neonates with hyperbilirubinemia
Time frame: Up to 2 weeks
Number of neonates with hypoglycemia
Time frame: Up to 2 weeks
Length of neonatal admission (days)
Time frame: Up to 3 weeks
Number of neonates with cephalohematoma
Time frame: Up to 2 weeks
Number of neonates have shoulder dystocia
Time frame: Up to 1 week
Number of neonates have admission to the NICU < 48 hours
Time frame: Up to 1 week
Number of cases with indication of caesarean section
Time frame: Up to 1 week
Number of cases with indication of instrumental delivery
Time frame: Up to 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Background: PubMed 22145497Martin 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.
- Background: PubMed 30089070Grobman 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.
- Background: PubMed 22030144Jozwiak 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.
- Background: PubMed 30790569Saad 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.
- Background: PubMed 29981523Dos 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.
- Background: PubMed 26850983Ten 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JinYing Yang, MD. principal investigator
Guangzhou Women and Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Induction of labor with Foley catheter and Induction of labor with PGE2 in people with Labor Induction and Induced Delivery, run by Guangzhou Women and Children's Medical Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cases with perinatal complications (time frame: Up to 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04780269, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.