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

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ClinicalTrials.gov Identifier: NCT04780269
Recruitment Status : Not yet recruiting
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Zehong Zhou, 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.

Condition or disease Intervention/treatment Phase
Labor Induction Induced Delivery Device: Induction of labor with Foley catheter Drug: Induction of labor with PGE2 Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Foley Catheter Versus Prostaglandin E2 Vaginal Suppository for Labor Induction at Term: a Pilot Study
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Dinoprostone suppositories




Primary Outcome Measures :
  1. 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.

  2. Percentage of vaginal delivery [ Time Frame: Up to 1 week ]
    The co-primary outcome is vaginal delivery.


Secondary Outcome Measures :
  1. Number of neonates need for respiratory support [ Time Frame: Up to 1 week ]
    Respiratory support within hours after birth

  2. Number of neonates with Apgar score < 7 at 1 minutes [ Time Frame: On the day of delivery ]
    Apgar scores of less than 7 at 1 min

  3. Number of neonates with Apgar score < 7 at 5 minutes [ Time Frame: On the day of delivery ]
    Apgar scores of less than 7 at 5 min

  4. Number of neonates with umbilical cord arterial pH < 7.10 [ Time Frame: On the day of delivery ]
    An assay of arterial cord blood pH of less than 7.10

  5. Number of neonates with birth trauma [ Time Frame: Up to 1 week ]
    Birth trama including bone fracture, neurologic injury, or retinal hemorrhage

  6. Number of neonates with hypoxic-ischemic encephalopathy or need for therapeutic hypothermia [ Time Frame: Up to 1 week ]
    Neonates diagnosed with hypoxic-ischemic encephalopathy or require therapeutic hypothermia

  7. Number of neonates with pneumonia [ Time Frame: Up to 2 weeks ]
    Pneumonia revealed by physical examination, blood test and image

  8. Number of neonates with seizure [ Time Frame: Up to 2 weeks ]
    Clinical signs of seizure

  9. Number of neonates with meconium aspiration syndrome [ Time Frame: Up to 2 week ]
    Diagnosed according to clinical symptoms, blood test and image

  10. Number of neonates with neonatal meningitis [ Time Frame: Up to 4 weeks ]
    Diagnosed by blood and cerebrospinal fluid test and image

  11. Number of neonates with neonatal sepsis [ Time Frame: Up to 2 weeks ]
    Diagnosed by clinical symptoms, blood test and bacterial culture

  12. Number of neonates with infant respiratory distress syndrome [ Time Frame: Up to 2 weeks ]
    Diagnosed by blood test and image

  13. Number of neonates with infant pneumothorax or pneumomediastinum [ Time Frame: Up to 2 weeks ]
    Diagnosed by thorax image

  14. Number of neonates with apnoea [ Time Frame: Up to 2 weeks ]
    Clinical diagnosis of apnoea

  15. Number of neonates with necrotising enterocolitis [ Time Frame: Up to 2 weeks ]
    Diagnosed by clinical symptoms, stool examination and image

  16. Number of neonates with clinical diagnosis of asphyxia [ Time Frame: Up to 2 weeks ]
    Clinical diagnosis of neonatal asphyxia

  17. Number of perinatal deaths [ Time Frame: up to 2 weeks ]
    Fetal or neonatal death occurring during childbirth

  18. Number of neonates with intraventricular hemorrhage [ Time Frame: Up to 2 week ]
    Intraventricular haemorrhage diagnosed by clinical symptoms and image

  19. Number of neonates admission to the NICU for >48 hours [ Time Frame: up to 2 weeks ]
    Length of admission to the NICU for less than 48 hours

  20. Number of cases with maternal secondary outcomes [ Time Frame: 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.

  21. Number of mothers with cardio-respiratory arrest [ Time Frame: Up to 2 weeks ]
    Clinical diagnosis of cardio-respiratory arrest

  22. Number of mothers with damage to internal organs [ Time Frame: Up to 2 weeks ]
    Damage to internal organs, including bowel, bladder or ureters

  23. Number of mothers with postpartum hemorrhage [ Time Frame: Up to 1 week ]
    Postpartum hemorrhage is defined as estimated blood loss >500 mL in the 24 hours after delivery

  24. Number of mothers have hysterectomy [ Time Frame: Up to 2 weeks ]
    Hysterectomy for any complications resulting from birth

  25. Number of mothers have intensive care admission [ Time Frame: Up to 3 weeks ]
    Admission of puerpera to ICU

  26. Number of mothers have uterine rupture [ Time Frame: Up to 2 weeks ]
    Uterine rupture refers to separation of the uterine wall

  27. Number of maternal infection [ Time Frame: Up to 2 weeks ]
    Maternal infection diagnosed by clinical symptoms, blood test, bacterial culture.

  28. Number of mothers have pulmonary embolism [ Time Frame: Up to 2 weeks ]
    Diagnosed by clinical symptoms, blood test and image

  29. Number of mothers have stroke [ Time Frame: Up to 2 weeks ]
    Diagnosed by clinical signs, blood test and cerebral image

  30. Scores of maternal satisfaction with the intervention of labor induction [ Time Frame: Up to 2 weeks ]
    Maternal satisfaction will be evaluated by a questionaire consisted of 11 questions scored on a 5-point Likert scale.

  31. Number of maternal death [ Time Frame: Up to 2 weeks ]
    Maternal death due to delivery

  32. Number of neonates with hyperbilirubinemia [ Time Frame: Up to 2 weeks ]
    Hyperbilirubinemia requiring photo-therapy or exchange transfusion

  33. Number of neonates with hypoglycemia [ Time Frame: Up to 2 weeks ]
    Hypoglycemia requiring intravenous therapy

  34. Length of neonatal admission (days) [ Time Frame: Up to 3 weeks ]
    Length of admission of neonate

  35. Number of neonates with cephalohematoma [ Time Frame: Up to 2 weeks ]
    Diagnosed by physical examination and image

  36. Number of neonates have shoulder dystocia [ Time Frame: Up to 1 week ]
    Diagnosed by physical examination and image

  37. Number of neonates have admission to the NICU < 48 hours [ Time Frame: Up to 1 week ]
    Admission of neonates to NICU for less than 48 hours

  38. Number of cases with indication of caesarean section [ Time Frame: 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

  39. Number of cases with indication of instrumental delivery [ Time Frame: 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


Other Outcome Measures:
  1. Number of cases with suspected intrapartum infection [ Time Frame: Up to 1 week ]
    Temperature ≥ 38°C during labor and/or use of broad-spectrum antibiotics due to suspected infection

  2. Number of cases with uterine hyperstimulation [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780269


Contacts
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Contact: Zehong Zhou, MD. +8613318890706 rainbow_0706@163.com
Contact: Jinying Yang, MD. +8613560092369 yangjinying1981@126.com

Locations
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China, Guangdong
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China, 510623
Contact: Zehong Zhou, MD.    +8613318890706    rainbow_0706@163.com   
Contact: Jinying Yang, MD.    +8613560092369    yangjinying1981@126.com   
Sponsors and Collaborators
Guangzhou Women and Children's Medical Center
Investigators
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Principal Investigator: JinYing Yang, MD. Guangzhou Women and Children's Medical Center
Publications:

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Responsible Party: Zehong Zhou, Principle investigator, Guangzhou Women and Children's Medical Center
ClinicalTrials.gov Identifier: NCT04780269    
Other Study ID Numbers: [2020]31201
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Zehong Zhou, Guangzhou Women and Children's Medical Center:
Labor induction
Term delivery with an unfavorable cervix
Foley catheter
Prostaglandin E2
Additional relevant MeSH terms:
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Dinoprostone
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs