Cervical Ripening for Induction of Labor: Misoprostol Versus Oxytocin in Conjunction With Foley Balloon
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/26/2018 |
| Start Date: | September 2009 |
| End Date: | March 2010 |
The purpose of this study is to specifically investigate the efficacy of an alternative
pharmacologic cervical ripening agent, misoprostol, versus the standard oxytocin, as an
adjunct to Foley balloon for induction of the unfavorable cervix.
pharmacologic cervical ripening agent, misoprostol, versus the standard oxytocin, as an
adjunct to Foley balloon for induction of the unfavorable cervix.
The design of this study is a randomized, controlled study with two arms. Both groups will
undergo placement of a Foley catheter, through the external and internal os of the cervix,
according to standard practice. In group A, receiving intravenous infusion of oxytocin, will
serve as the control group as it is standard protocol at Aultman Hospital. Group B,
intravaginal placement of misoprostol, will serve as the experimental group. The expected
duration of participation begins at induction of labor and concludes at time of delivery.
undergo placement of a Foley catheter, through the external and internal os of the cervix,
according to standard practice. In group A, receiving intravenous infusion of oxytocin, will
serve as the control group as it is standard protocol at Aultman Hospital. Group B,
intravaginal placement of misoprostol, will serve as the experimental group. The expected
duration of participation begins at induction of labor and concludes at time of delivery.
Inclusion Criteria:
- Participant or surrogate is capable of giving informed consent
- Anticipated number - 50 patients with 25 in each study arm Female with singleton
gestation, live intrauterine pregnancy
- Participant is undergoing an indicated induction of labor
- Participant is found to have cervical Bishop score ≤5 on initial cervical exam
- Participant has no medical or obstetrical contraindications to induction of labor
Exclusion Criteria:
- Participant has ≥2 painful contractions in 10 min in 2 subsequent 10 min periods
- Manufacturer's contraindications to misoprostol or oxytocin
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