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Cervical Ripening for Obese Women: A Randomized, Comparative Effectiveness Trial (CROWN)

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ClinicalTrials.gov Identifier: NCT02639429
Recruitment Status : Completed
First Posted : December 24, 2015
Results First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Mesk A.Jawad Alrais, The University of Texas Health Science Center, Houston

Brief Summary:
Obese pregnant women (BMI ≥ 30 kg/m2) are more likely than their normal-weight counterparts to require induction of labor because of increased rates of obstetric complications including pregnancy related hypertensive disorders, diabetes, and prolonged gestations. Several studies have shown that obese women experience increased labor duration and oxytocin needs when compared to normal-weight women. This in turn results in increased rates for unplanned cesarean delivery (CD) as a result of failed induction of labor (IOL), arrest disorders and non-reassuring fetal heart rate tracing, that is dose-dependent with increasing class of obesity. The investigators hypothesize that obese pregnant women and unfavorable cervix (Bishop score ≤ 6), IOL ≥ 24 weeks gestation using the Foley balloon plus vaginal misoprostol will result in reduced cesarean delivery rates when compared to vaginal misoprostol alone.

Condition or disease Intervention/treatment Phase
Obesity Labor Induction Cesarean Delivery Drug: Vaginal Misoprostol Device: Foley Balloon + Vaginal Misoprostol Phase 4

Detailed Description:

Nulliparous pregnant women at ≥ 32 weeks' gestation admitted to labor and delivery for IOL and who meet the inclusion and exclusion criteria will be approached by the research staff. Group 1 will be composed of women allocated to the Foley balloon plus misoprostol. These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team.

Group 2 will be composed of women allocated to vaginal misoprostol-only. These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Similarly, further management will be left at the discretion of the labor team.

In both groups, if IV oxytocin is indicated, it will be withheld until 4 hours after the last dose of misoprostol to prevent uterine hyperstimulation. Other aspects of labor management will be similar for both groups, including continuous electronic fetal monitoring with external Doppler device or fetal scalp electrode. Uterine contraction assessment will be performed with either an external tocodynamometer or an intrauterine pressure catheter.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of Transcervical Foley Balloon Plus Vaginal Misoprostol Versus Vaginal Misoprostol Alone For Cervical Ripening In Nulliparous Obese Women: A Randomized, Comparative Effectiveness Trial
Study Start Date : January 2016
Actual Primary Completion Date : June 24, 2018
Actual Study Completion Date : June 24, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

Arm Intervention/treatment
Experimental: Combined approach: Foley Balloon + Vaginal Misoprostol
These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team.
Device: Foley Balloon + Vaginal Misoprostol
Active Comparator: Single approach: Vaginal Misoprostol only
These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team.
Drug: Vaginal Misoprostol
Other Name: Cytotec




Primary Outcome Measures :
  1. Number of Participants With a Need for Cesarean Delivery [ Time Frame: Induction to delivery ]

Secondary Outcome Measures :
  1. Indication for Cesarean Delivery [ Time Frame: Induction to delivery ]

    Categories of Indications for Cesarean Delivery:

    1. = Cephalopelvic disproportion
    2. = Failed induction/Failure to progress
    3. = Cord prolapse
    4. = Non-reassuring fetal tracing
    5. = Malpresentation
    6. = Placental abruption
    7. = Other

  2. Induction-to-delivery Interval in Hours [ Time Frame: Induction to delivery ]
  3. Number of Participants With a Need for Oxytocin Augmentation [ Time Frame: Induction to delivery ]
  4. Number of Participants Exhibiting Tachysystole Resulting in Fetal Heart Rate Abnormalities [ Time Frame: Induction to delivery ]
    Uterine tachysystole is a condition of excessively frequent uterine contractions during pregnancy. Tachysystole is indicated ≥ 5 contractions in a 10 minute period averaged over a 30-minute window.

  5. Number of Participants With Clinical Chorioamnionitis [ Time Frame: Induction to delivery ]
    Clinical chorioamnionitis is indicated by maternal fever ≥ 100.4 Fahrenheit, uterine fundal tenderness, maternal or fetal tachycardia (>100/min and >160/min, respectively), and purulent or foul amniotic fluid.

  6. Number of Participants With a Need for Operative Vaginal Delivery [ Time Frame: Induction to delivery ]
  7. Composite Maternal Morbidity as Indicated by the Number of Participants With Measures of Maternal Morbidity [ Time Frame: Induction to discharge (approximately 5 days) ]

    Measures of maternal morbidity assessed:

    • Maternal ICU admission
    • Postpartum endometritis
    • Surgical-site infections prior to discharge
    • Venous thromboembolism
    • Need for transfusion
    • Maternal death

  8. Number of Newborns Admitted to the Neonatal Intensive Care Unit (NICU) [ Time Frame: From delivery to neonatal discharge (approximately 2 to 7 days) ]
  9. Number of Newborns With Transient Tachypnea (TTN) [ Time Frame: From delivery to neonatal discharge (approximately 2 to 7 days) ]
  10. Number of Newborns With Respiratory Distress Syndrome (RDS) [ Time Frame: From delivery to neonatal discharge (approximately 2 to 7 days) ]
  11. Number of Newborns With Meconium Aspiration Syndrome [ Time Frame: From delivery to neonatal discharge (approximately 2 to 7 days) ]
  12. Number of Newborns With Culture-proven Sepsis [ Time Frame: From delivery to neonatal discharge (approximately 2 to 7 days) ]
  13. Number of Newborns With Seizures [ Time Frame: From delivery to neonatal discharge (approximately 2 to 7 days) ]
  14. Composite Neonatal Morbidity as Indicated by the Number of Newborns With Measures of Neonatal Morbidity [ Time Frame: From delivery to neonatal discharge (approximately 2 to 7 days) ]

    Measures of neonatal morbidity assessed:

    • Apgar score ≤ 7 at 5 mins
    • Umbilical cord potential of hydrogen (pH) < 7.1
    • Neonatal injury: brachial plexus injury, fracture
    • Perinatal death



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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

  • Nulliparous women aged 18 or above
  • BMI ≥ 30 at the time of labor induction
  • Singleton gestation
  • Cephalic presentation (includes successful external cephalic version)
  • Intact fetal membranes
  • Unfavorable cervix (Bishop score of ≤ 6)
  • Gestational age ≥ 32 weeks

Exclusion Criteria

  • Patient not candidate for IOL with misoprostol as deemed by the treating physician
  • Multiple gestation
  • Major fetal anomalies
  • Fetal demise

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): NCT02639429


Locations
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United States, Texas
The University of Texas Health Science Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
  Study Documents (Full-Text)

Documents provided by Mesk A.Jawad Alrais, The University of Texas Health Science Center, Houston:

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Responsible Party: Mesk A.Jawad Alrais, Clinical Resident, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02639429     History of Changes
Other Study ID Numbers: HSC-MS-15-0895
First Posted: December 24, 2015    Key Record Dates
Results First Posted: August 26, 2019
Last Update Posted: August 26, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics