Foley Bulb With Oral Misoprostol for Induction of Labor
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 10 - Any |
| Updated: | 2/10/2019 |
| Start Date: | January 1, 2018 |
| End Date: | December 2020 |
| Contact: | Study Coordinator |
| Email: | lisa.moseley@utsouthwestern.edu |
| Phone: | 214-648-2591 |
Foley Bulb With Oral Misoprostol Versus Oral Misoprostol for Induction of Labor: A Cluster Randomized Trial
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.
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.
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.
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.
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
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