Clinical trial NCT03407625: Foley Bulb With Oral Misoprostol for Induction of Labor
Official title: Foley Bulb With Oral Misoprostol Versus Oral Misoprostol for Induction of Labor: A Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Labor, Induced
Keywords: Pregnancy
Labor Induction
Cervical Ripening
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 2227
Sex: FEMALE
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized trial
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Vaginal Delivery
timeFrame: at delivery
Secondary outcomes:
measure: Time to Delivery
timeFrame: from start of induction agent to time of delivery
measure: Indication for Cesarean Delivery
timeFrame: at delivery
measure: Dose of Oxytocin Given (mcg or mg)
timeFrame: at delivery
measure: Time With Foley Bulb in Place
timeFrame: From time of documented insertion until the time of documented expulsion or removal, whichever came first, assessed up to 24 hours.
measure: Presence of Chorioamnionitis
timeFrame: at delivery
measure: Use of Intravenous Analgesia During Labor
timeFrame: at delivery
measure: Number of Participants Used Neuraxial Analgesia During Labor
timeFrame: from start of induction to delivery
measure: Number of Participants Used General Anesthesia for Delivery
timeFrame: at delivery
measure: Number of Participants With Meconium-stained Amniotic Fluid
timeFrame: At the time of rupture of membranes and at delivery
measure: Terbutaline Use
timeFrame: at delivery
measure: Number of Participants With Tachysystole
timeFrame: at delivery
measure: Number of Participants With Uterine Hyperstimulation Syndrome
timeFrame: at delivery
measure: Number of Participants With Excess Blood Loss
timeFrame: at delivery
measure: Number of Participants With Blood Transfusion
timeFrame: at delivery
measure: Number of Participants With Uterine Rupture
timeFrame: at delivery
measure: Number of Participants With Unplanned Hysterectomy
timeFrame: at discharge from the hospital following delivery
measure: Number of Participants With Postpartum Fever
timeFrame: Following delivery and prior to discharge
measure: Number of Participants With Umbilical Cord Blood pH <7.0
timeFrame: at delivery
measure: Number of Participants With an 5-minute Apgar Score Less Than 4
timeFrame: 5 minutes after time of birth
measure: Number of Participants That Needed Mechanical Ventilation in Delivery Room (Yes/No)
timeFrame: at delivery
measure: Number of Participants Administered Neonatal Antibiotics and/or Neonatal Blood Cultures
timeFrame: From time of birth until the time of discharge or up to 7 days of life, whichever comes first.
measure: Number of Participants With Neonatal Sepsis
timeFrame: From time of birth until the time of discharge or up to 7 days of life, whichever comes first.
measure: Number of Participants With NICU Admission Order
timeFrame: From time of birth until the time of discharge or up to 7 days of life, whichever comes first.
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Health and Hospital Systems
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Emily H Adhikari, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Adhikari EH, Nelson DB, McIntire DD, Leveno KJ. Foley Bulb Added to an Oral Misoprostol Induction Protocol: A Cluster Randomized Trial. Obstet Gynecol. 2020 Nov;136(5):953-961. doi: 10.1097/AOG.0000000000004123.