Vaginal Misoprostol versus Foley Catheter plus Oxytocin for Labour Induction

6 Nov, 10

A Randomized Controlled Trial Comparing Vaginal Misoprostol Versus Foley Catheter Plus Oxytocin for Labor Induction

Aim

To compare effectiveness and safety of 25 mcg vaginal tablet of Misoprostol versus Foley catheter and Oxytocin for cervical ripening and labor induction in pregnant women with unripe cervices

Material and Methods

Results

Profile of labor and indication for cesarean section in both groups.

^ac² test, p = 0.04

With respect to women in the misoprostol group,

Cumulative percentage of women delivering vaginally according to time and method of induction (n = 87 for misoprostol group and n = 77 for Foley + oxytocin group).

Abnormalities in uterine contraction and fetal well-being during labor, and neonatal outcomes in both groups

^ac² test. ^bFisher's exact test

Material side effects and complications^a in both groups

^aNot significant

Conclusions

Reference: Acta Obstetricia et Gynecologica. 2010; 89:1045-1052

25-mcg vaginal tablet of misoprostol, every 6 hours, was more effective than the Foley catheter and oxytocin in obtaining vaginal delivery when inducing labor in pregnant women with an unripe cervix, at least at 12 and 18 hours after starting induction. Maternal and fetal adverse effects were rare and statistically similar in both groups.
Vaginal misoprostol is more effective than and as safe as Foley catheter and oxytocin for induction of labor in term and postterm pregnancy.

No significant differences between the two groups in the incidence of maternal complications and side effects.

No significant differences between the two groups with respect to contractions and fetal well-being during labor, nor any difference in neonatal outcome

Survival analysis of the cumulative percentage of women delivering across time showed that the time to vaginal delivery was shorter in women in the misoprostol group.

32.8% required only one dose
22.7% needed two doses
15.9% needed three doses
28.6% needed four doses

More vaginal deliveries in the misoprostol group at12 (p< 0.001) and 18 (p = 0.007) hours.
Mean induction-to-vaginal delivery time with misoprostol was shorter (17.3 vs. 20.2 hours) p = 0.016.

A randomized controlled trial.
N = 240 pregnant women with a term or post-term, live, singleton fetus in cephalic presentation, intact membranes, Bishop score <6, not in labor, medically indicated for labor induction.
Randomly divided in
- Group 1, n = 119 women received 25 mcg of intravaginal misoprostol placed in the posterior fornix every 6 hours for a maximum of four doses. Medication stopped after the onset of labor. Oxytocin started 6 hours after the last dose of misoprostol in whom labor had not begun but Bishop score was >5. The remaining women considered induction failures and submitted to cesarean section.
- Group 2, n = 121 women had a 14-F Foley catheter inserted into their cervical canal. Once past the internal os, the balloon was inflated. Intravenous oxytocin initiated after the balloon spontaneously extruded from the cervix or after 24 hours. Intravenous oxytocin initiated at an infusion flow rate of 4 mU/minute and doubled as necessary, with 30-minute intervals between doses, up to a maximum of 16 mU/minute. (5 IU of synthetic oxytocin added to 500 ml of a 5% dextrose)
Main objective
- To evaluate the number of successful inductions within 48 hours
- The number of deliveries within 12,18,24 and 48 hours
- The length of time between the beginning of induction and the onset of labor (time to active labor), total time of induction, type of delivery, number of required doses of misoprostol, side effects and neonatal outcomes were assessed.