Labor Induction and Maternal BMI, Comparison of Different Pre-induction Cervical Ripening Methods

Overview

The purpose of this study is to investigate whether mechanical cervical ripening (using the Cook double balloon catheter) is superior or inferior to pharmacological agents (PGE1) in overweight and obese women undergoing labor induction.

Full Title of Study: “Labor Induction and Maternal BMI: Comparison of Different Pre-induction Cervical Ripening Methods: The Cook Double Balloon Catheter vs PGE1 Tablets in Lean, Overweight, and Obese Women. A Prospective Randomized Study.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2016

Interventions

  • Device: Cook double balloon catheter
  • Drug: PGE1 tablet

Arms, Groups and Cohorts

  • Experimental: Cook double balloon catheter
    • Insertion of the Cook double balloon catheter to the cervix until both balloons are properly located in the cervical canal. After properly located it is inflated with 20 ml of saline. Then both balloons are additionally inflated to a total of 80 ml each balloon. Twelve hours later the balloons are deflated and the device is removed.
  • Active Comparator: PGE1 tablet insertion
    • Insertion of 25 mg PGE1 (Prostaglandin E1) tablet is inserted in the posterior fornix. The patient woll the be instructed to stay in bed for the next 60 minutes. After six hours a repeated dose will be administered. Total of 4 PGE1 doses within 24 hours.

Clinical Trial Outcome Measures

Primary Measures

  • Cesarian section rate
    • Time Frame: 24 hours

Secondary Measures

  • Incidence of excessive uterine activity Incidence of excessive uterine activity
    • Time Frame: 24 hours
    • At least 6 uterine contractions per 10- minutes period, or hyperstimulation, if combined with fetal heart rate abnormalities, or hypertonus defined as single contraction of 2-minute duration.
  • Active labor onset
    • Time Frame: 24 hours
  • Proportion of vaginal delivery
    • Time Frame: 24 hours
  • Treatment failure
    • Time Frame: 12-24 hours
    • Proportion of subjects with unfavorable/unchanged Bishop score 12-24 hours after ripening
  • The ripening-to-delivery time interval
    • Time Frame: 24 hours
  • Need for oxytocin induction and/or augmentation of labor
    • Time Frame: 24 hours
  • Mode of delivery
    • Time Frame: 24 hours
    • NVD vs. instrumental
  • Intra-partum or postpartum fever
    • Time Frame: 48 hours
  • Incidence of meconium staining
    • Time Frame: 24 hours
  • The proportion of neonates with 5-minute Apgar scores of less than 7
    • Time Frame: 48 hours
  • The number of neonates who were admitted to the neonatal intensive care unit
    • Time Frame: 48 hours
  • morbidity and mortality
    • Time Frame: 48 hours
    • Number of cases of serious maternal and/or neonatal morbidity or death (including uterine rupture, maternal admission to the intensive care unit, maternal septicemia, placental abruption, hemorrhage at required blood transfusion, hysterectomy, neonatal seizures, birth asphyxia, meconium aspiration syndrome, or neonatal sepsis).

Participating in This Clinical Trial

Inclusion Criteria

  • Age 18 years of age or older.
  • Diagnosed to be pregnant (al least 37 weeks of gestation) with a medical indication for labor induction, including: postdate pregnancy, preeclampsia, gestational or chronic hypertension, Gestational Diabetes Mellitus at term, Oligohydramnios, Polyhydramnios, fetal growth restriction, maternal background disease necessitating delivery, Isoimmunisation, maternal Thrombophilia, intrahepatic cholestasis of pregnancy.
  • Having a Bishop score of 4 points or less.
  • Diagnosed as having singleton pregnancy at term (37 weeks at least) in a vertex presentation, with intact membranes, and absence of significant regular uterine contraction.
  • Willingness to comply with the protocol for the duration of the study.
  • Has agreed and signed an informed consent after given oral and written explanation.

Exclusion Criteria

  • Anay contraindication for a vaginal delivery (i.e. placenta previa, non vertex presentation, estimated fetal weight of less than 4500 gr).
  • Ruptured membranes.
  • Previous cesarian section or presence of any uterine scar.
  • Documented labor with four or more spontanous uterine contractions per hour.
  • Suspected fetal distress necessitating immediate intervention.
  • Proven malignancy of the cervix.
  • Active vaginal bleeding.
  • Active inflammatory or purulent condition of the lower genital tract.
  • Active asthma.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hillel Yaffe Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Saja Murra Anabosy, MD, Principal Investigator, Hillel Yaffe Medical Center
    • Asnat Walfisch, MD, Study Chair, Hillel Yaffe Medical Center
  • Overall Contact(s)
    • Saja Murra Anabosy, MD, +972 50 9260067, saja83@gmail.com

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