Cervical Ripening for Obese Women: A Randomized, Comparative Effectiveness Trial
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Women's Studies |
| Therapuetic Areas: | Endocrinology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/20/2019 |
| Start Date: | January 2016 |
| End Date: | September 9, 2019 |
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
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.
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.
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.
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.
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
We found this trial at
1
site
Houston, Texas 77030
Principal Investigator: Oscar A Viteri, MD
Phone: 713-500-6421
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