Comparison Misoprostol versus Oxytocin in term pregnancy
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Comparison Misoprostol versus Oxytocin in term pregnancy
- 1. A randomized comparison of Oral misoprostol versus Foley catheter and oxytocin for induction of labor at term Mediana Sutopo Liedapraja PPDS Tahap 1 A OBGYN FKUI - RSCM
- 3. OBJECTIVE: Compare the efficacy and safety of oral misoprostol administered to patients with the efficacy and safety in a control group treated with a Foley catheter and oxytocin for induction of labor. Control
- 4. STUDY DESIGN 200 patients 100 Patients Oral Misoprostol (50mcg with 4 hours interval) *max dose 300mcg 100 Patients Cervical Foley Catheter + Oxytocin *max 36mU/min Inclusion Criterias: - Term pregnancy -Singleton live fetus -Cephalic presentation -Intact membrane -Bishop Score 5 or less -Not in Labor ( <3x contractions in 10 minutes) Exclusion Criterias: - Nonreassuring FHR -Multiple Gestation -Previous SC or uterine surgery -Rupture membrane -Placenta previa -Genital herpes, asthma Control
- 6. 100 Patients Oral Misoprostol (50mcg with 4 hours interval) *max dose 300mcg
- 7. Control All patients underwent continuous EFM from start induction until delivery Failed induction
- 10. Outcomes
- 12. DISCUSSION RCT Misoprostol as effective agents for cx ripening and labor induction Main concern !!! Excessive uterine contractions Primary outcome ( Delivery within 24 hours) lower in misoprostol group Oral Misoprostol SIGNIFICANTLY less effective in nulliparous parturients
- 13. 200mcg oral every 6 hours UNACCEPTABLE high rate of hyperstimulation syndrome ( 44.1%) 50 to 100 mcg at 2-3 hours interval High Clinical Utility with ACCEPTABLE rate of hyperstimulation syndrome. Oral misoprostol at the dose described is a reasonable alternative to oxytocin–Foley catheter for induction of labor, particularly in multiparous patients.
- 15. THANK YOU
Editor's Notes
- Perbandingan Efektivitas, Keamanan Oral Misoprostol Kontrol
- Two hundred patients requiring induction of labor at term with a Bishop score of ²5 were randomized to receive oral misoprostol or a cervical Foley catheter plus oxytocin. Patients in the misoprostol group received 50 mg at 4-hour intervals for a maximum of 6 doses or until an adequate contraction pattern developed. Those in the control group had a Foley catheter inserted in the cervix, whereas oxytocin was administered intravenously by a standard incremental infusion protocol to a maximum dose of 36 mU/min. Patients were excluded if they had any of the following: a nonreassuring fetal heart rate tracing, multifetal gestation, previous cesarean delivery or previous uterine surgery, ruptured membranes, placenta previa, active genital herpes, maternal asthma, sickle cell disease, or known hypersensitivity to prostaglandins.
- If she was having at least 3 contractions in 10 minutes lasting for ³50 seconds (regardless of the cervical change), then misoprostol was withheld until the next dose was due 4 hours later. If, after 24 hours from the start of induction, the patient was not in active labor or had dysfunctional labor, then oxytocin augmentation or a combination of cervical Foley catheter balloon and oxytocin therapy was started.
- intervals until adequate uterine activity was maintained (3 contractions in 10 minutes).. In patients without any cervical dilation, a Foley catheter was inserted into the cervix under direct visualization. A speculum was placed into the vagina, and the cervix was cleaned with an antiseptic solution. 16F balloon-tipped Foley catheter was passed through the cervix beyond the internal os inflated with 30 mL of sterile sodium chloride solution. The balloon was deflated, and the device was removed after 12 hours if it had not been spontaneously expelled. Oxytocin was started concomitantly with the insertion of the Foley catheter. Failed Induction was defined as failure to enter the active phase (inability to dilate the cervix beyond 4 cm) of labor within 24 hours after the start of induction.
- The primary outcome measure was delivery within 24 hours from the start of induction (Table II). This was significantly lower in the misoprostol group (68.4% vs 84.8%; relative risk, 0.82; 95% confidence interval, 0.70- 0.96). the median induction-to-delivery time was longer with misoprostol (18.4 hours vs 14.4. hours; P = .01).
- In nulliparous women delivery within 24 hours occurred in 53.4% of the misoprostol group versus 82.5% of the control group (relative risk, 0.65; 95% confidence interval, 0.50-0.85). The median induction-to-delivery time was also longer (23.3 hours vs 17.2 hours; P &lt; .01).
- There were no significant differences in these 2 outcomes in the multiparous women
- Newborn intensive care unit admissions were more common in the control group, But this difference did not reach statistical significance.
- A large number of randomized trials suggest that vaginally administered misoprostol is an effective agent for cervical ripening and labor induction. The main concern with this technique is the incidence of excessive uterine contractions, which appears to be dose related. The higher the misoprostol dose, the shorter the induction to- delivery time but the higher the rate of uterine hyperstimulation. 3 Data regarding oral misoprostol for induction of labor is much more limited. To date, only 5 randomized trials have addressed the safety and efficacy of oral misoprostol. 4-8 The results of these trials were variable regarding induction-to-delivery time and hyperstimulation syndrome. Our study reveals that the primary outcome measure of delivery within 24 hours from the start of induction was significantly lower in the misoprostol group. Oral misoprostol was comparable with our standard induction protocol in multiparous women but significantly less effective in nulliparous parturients
- Data on the pharmacokinetics of oral misoprostol in patients undergoing first-trimester abortion indicate that the time to peak plasma concentration is 34 ± 17 minutes, with a steep decline by 120 minutes.11 Oral misoprostol has all the properties that constitute a viable technique for labor induction. It is efficacious, inexpensive, easily administered, stable at room temperature, and well tolerated by the mother and fetus. In contrast to oxytocin, misoprostol does not have to be mixed, and tubing and infusion pumps do not have to be used, reducing the possibility of drug errors. Several studies have suggested that misoprostol is cost-effective in inducing labor.10, 12