Foley Bulb With Oral Misoprostol for Induction of Labor

Study Overview
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Brief Summary
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Induction of labor is associated with increased cesarean delivery rates, particularly in women with an unfavorable cervix. Both pharmacologic and mechanical methods are utilized for cervical ripening and labor induction. Evidence on the safety and effectiveness of various mechanical and pharmacologic methods of cervical ripening and labor induction is abundant, and yet the majority of clinical trials evaluate time to delivery, rather than mode of delivery. This is a prospective, cluster-randomized clinical trial to compare a standard method of induction at our institution (oral misoprostol) with an alternative, commonly used combination method of oral misoprostol and transcervical foley bulb in women with term pregnancies requiring induction of labor.

Detailed Description
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The purpose of this study is to determine whether the use of a transcervical foley catheter, in combination with the standard oral misoprostol regimen will result in a decreased primary cesarean delivery rate among women with a cervical dilation of 2 centimeters of less who require induction of labor at term. This study is not an FDA-regulated study: there is no intent to test the foley bulb under an FDA-regulated protocol. Likewise, there is no intent to submit the results of this study for a change in the labeling of the foley used for this study. This study was approved by the Institutional Review Board of the University of Texas Southwestern Medical Center, and by the Office of Research Administration at Parkland Health and Hospital System. This will be a prospective, cluster-randomized trial comparing two accepted methods of induction of labor at term among women who present for delivery at Parkland Hospital. Eligible participants will include nulliparous and multiparous women at 37 weeks gestation or greater, with a living, singleton fetus and no major fetal malformations, in cephalic presentation, with intact membranes, no prior uterine scar, who qualify for prostaglandin administration and who have a cervical dilation of 2 centimeters or less, measured at the level of the internal os. Patients with latex allergy, non-reassuring fetal status, HIV, active herpes outbreak, a prior uterine scar, or any contraindication to prostaglandins (including 4 or more painful contractions per 10 minutes prior to prostaglandin administration) will be excluded from participation in the study. Computer-generated cluster randomization will occur on a weekly basis for all study participants, to either the combination method of foley bulb plus oral misoprostol regimen (study group) or to oral misoprostol alone regimen (control). According to the randomization protocol each week, participants will be randomized to either the standard of care (oral misoprostol/control group) or standard of care plus foley bulb (study group). The study group will undergo placement of a 30 French foley catheter filled with 30-35cc sterile saline into the cervix in addition to the standard regimen of oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses, for patients who meet criteria for fetal well-being, and do not had more than 4 painful contractions in 10 minutes. Misoprostol will not be administered to patients who have progressed to active labor, defined as 4 centimeters cervical dilation. The control group will undergo induction with our current standard oral misoprostol protocol alone, administered as 100 micrograms given every 4 hours for a maximum of 2 doses. Both groups will receive oxytocin as indicated by current labor protocols at our institution. The primary outcome will be the rate of vaginal delivery. Secondary outcomes will include obstetric outcomes, maternal outcomes, and neonatal outcomes. Obstetric outcomes will include indication for induction, need for oxytocin, indication for cesarean delivery, time to active labor, time to delivery, labor analgesia, presence of chorioamnionitis, meconium-stained amniotic fluid, terbutaline use, tachysystole (defined as 6 or more contractions in 10 minutes or tetanic contraction of 120 seconds or longer) or hyperstimulation syndrome (defined as tachysystole accompanied by fetal heart rate decelerations). Maternal outcomes will include estimated blood loss, transfusion requirement, postpartum fever, uterine rupture, and unplanned hysterectomy. Neonatal outcomes will include umbilical cord blood pH, 5-minute APGAR score, intubation or ventilation in the delivery room, neonatal sepsis, and admission to Neonatal Intensive Care Unit (NICU) admission.

Official Title
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Foley Bulb With Oral Misoprostol Versus Oral Misoprostol for Induction of Labor: A Cluster Randomized Trial

Conditions
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Pregnancy, Labor, Induced

Intervention / Treatment
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* Other: Foley bulb plus Oral Misoprostol
* Other: Oral Misoprostol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 37 weeks gestation or greater Living, singleton fetus No major fetal malformations Cephalic presentation No prior uterine scar Intact fetal membranes Qualifies for prostaglandin administration according to current Parkland protocol Have a cervical dilation of 2 centimeters or less, measured at the level of the internal os Have an indication for induction or attempted induction of labor according to Parkland protocol Exclusion Criteria: latex allergy non-reassuring fetal status HIV active herpes outbreak Prior uterine scar Contraindication to prostaglandins according to current Parkland protocol Contraindication to vaginal delivery

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Foley bulb plus Oral Misoprostol<br>Patients will received initial transcervical foley bulb, followed by oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. | Other: Foley bulb plus Oral Misoprostol<br>* Although labeled experimental for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States.<br>|
| Active Comparator: Oral Misoprostol<br>Patients will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. | Other: Oral Misoprostol<br>* Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Vaginal Delivery | vaginal delivery at first induction | at delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Delivery | Time (in hours) from start of induction agent to delivery at first induction | from start of induction agent to time of delivery | 
| Indication for Cesarean Delivery | Among women delivered by cesarean, the indication for cesarean | at delivery | 
| Dose of Oxytocin Given (mcg or mg) | Total dose of oxytocin given for induction as calculated by volume infused, concentration of solution and rate of infusion | at delivery | 
| Time With Foley Bulb in Place | time (in hours) from insertion to removal or expulsion of foley bulb | From time of documented insertion until the time of documented expulsion or removal, whichever came first, assessed up to 24 hours. | 
| Presence of Chorioamnionitis | Intrapartum fever (temp equal or greater than 38C) with no other identified cause | at delivery | 
| Use of Intravenous Analgesia During Labor | Intravenous analgesia used between the start of induction and delivery | at delivery | 
| Number of Participants Used Neuraxial Analgesia During Labor | Regional or neuraxial analgesia (labor epidural or spinal) used between the start of induction and delivery | from start of induction to delivery | 
| Number of Participants Used General Anesthesia for Delivery | General anesthesia administered for delivery | at delivery | 
| Number of Participants With Meconium-stained Amniotic Fluid | Identification of any meconium (green tinge) in the amniotic fluid before or during delivery by a healthcare provider's assessment of gross fluid color. | At the time of rupture of membranes and at delivery | 
| Terbutaline Use | Administration of terbutaline, a tocolytic agent, for tetanic contractions with or without fetal heart rate decelerations | at delivery | 
| Number of Participants With Tachysystole | 6 or more contractions in 10 minutes or tetanic contraction of 120 seconds or longer | at delivery | 
| Number of Participants With Uterine Hyperstimulation Syndrome | Tachysystole accompanied by fetal heart rate decelerations | at delivery | 
| Number of Participants With Excess Blood Loss | Maternal excess blood loss is defined as >500ml for vaginal and >1000ml for cesarean delivery | at delivery | 
| Number of Participants With Blood Transfusion | administration of blood products related to delivery blood loss | at delivery | 
| Number of Participants With Uterine Rupture | spontaneous separation of myometrium in a previously intact, unscarred uterus | at delivery | 
| Number of Participants With Unplanned Hysterectomy | unplanned removal of the uterus following delivery of the fetus | at discharge from the hospital following delivery | 
| Number of Participants With Postpartum Fever | Fever recorded in the time after delivery but prior to discharge from the hospital, with clinical assessment of endometritis | Following delivery and prior to discharge | 
| Number of Participants With Umbilical Cord Blood pH <7.0 | Arterial or venous cord blood pH defined as <7.0 | at delivery | 
| Number of Participants With an 5-minute Apgar Score Less Than 4 | Appearance, Pulse, Grimace, Activity, Respirations - scored from 0 to 2 for each component, added to make a total score and used as an assessment of initial response to newborn resuscitation, lower scores associated with poor outcomes. Here defined as Apgar less than 4 at 5 minutes. | 5 minutes after time of birth | 
| Number of Participants That Needed Mechanical Ventilation in Delivery Room (Yes/No) | Intubation with mechanical support or control of neonatal breathing in delivery room | at delivery | 
| Number of Participants Administered Neonatal Antibiotics and/or Neonatal Blood Cultures | Administration of neonatal antibiotics and/or neonatal blood cultures | From time of birth until the time of discharge or up to 7 days of life, whichever comes first. | 
| Number of Participants With Neonatal Sepsis | Neonatal bacteremia as defined by bacterial growth in blood cultures | From time of birth until the time of discharge or up to 7 days of life, whichever comes first. | 
| Number of Participants With NICU Admission Order | Admission order to neonatal intensive care unit (NICU) placed between the time of delivery and infant discharge | From time of birth until the time of discharge or up to 7 days of life, whichever comes first. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Labor Induction, Cervical Ripening