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OBSTETRICS
Randomized clinical trial between hourly titrated oral
misoprostol and vaginal dinoprostone for induction of labor
Abdulrahim A. Rouzi, MB, ChB, FRCSC; Sharifa Alsibiani, MD; Nisma Mansouri, MD;
Nawal Alsinani, MD; Khalid Darhouse, MRCOG
OBJECTIVE: The objective of the study was to compare the efficacy and achieved within 24 hours in 100 women (62.5%): 44 in the dino-
safety of hourly titrated oral misoprostol with vaginal dinoprostone insert. prostone group (55.0%) and 56 in the misoprostol group (70.0%) (P ¼
.05). The proportion of women who achieved vaginal delivery within
STUDY DESIGN: Subjects were randomized into hourly titrated oral
24 hours was significantly greater for nulliparous women in the
misoprostol or dinoprostone 10 mg vaginal insert. Misoprostol was
misoprostol group (24 of 51, 58.5%) compared with the dinoprostone
given as 20 mg hourly for 2 doses. In the absence of regular uterine
group (12 of 36, 33.3%; P ¼ .0270). Significantly more women with
contractions, the dose was increased to 30 mg hourly for 3 doses and
baseline Bishop score of 3 or less in the misoprostol group had suc-
then 40 mg for 1 dose, 50 mg for 1 dose, and 60 mg hourly for 4 doses.
cessful induction (43 of 59, 72.9%) compared with the dinoprostone
Before the 40 and 50 mg doses, 1 more hour of observation was given.
group (27 of 60, 45.0%; P ¼ .002). Frequencies of maternal adverse
The primary outcome variable was vaginal delivery within 24 hours.
events were similar between groups.
Safety assessments included the incidence of maternal morbidity and
adverse neonatal outcomes. CONCLUSION: Hourly titrated oral misoprostol can provide an effica-
cious and safe substitute for the expensive dinoprostone vaginal insert.
RESULTS: A total of 160 women was enrolled in the study. The groups
were similar for demographic and clinical factors. Vaginal delivery was Key words: hourly, misoprostol, oral, titrated
Cite this article as: Rouzi AA, Alsibiani S, Mansouri N, et al. Randomized clinical trial between hourly titrated oral misoprostol and vaginal dinoprostone for induction of
labor. Am J Obstet Gynecol 2014;210:56.e1-6.
TABLE 2
Labor outcomes
Outcome Dinoprostone Misoprostol P value (RR; 95% CI)
Delivered vaginally in 24 h 44/80 (55.0) 56/80 (70.0) .050 (1.273; 0.997e1.626)
Delivered vaginally in 12 h 26/80 (32.5) 18/80 (22.5) .156 (0.692; 0.414e1.159)
First treatment to vaginal birth, mean h 20.2 18.0 (n ¼ 62) 17.6 8.5 (n ¼ 71) .301
Cesarean section 18/80 (22.5) 9/80 (11.3) .057 (0.500; 0.239e1.046)
Subgroups: vaginal delivery in 24 h
Parity
Nulliparous 12/36 (33.3) 24/41 (58.5) .027
Multiparous 32/44 (72.7) 32/39 (82.0) .313
Indication
Postterm 25/45 (55.6) 37/48 (77.1) .028
Other 19/35 (54.3) 19/32 (59.4) .671
Bishop score
3 27/60 (45.0) 43/59 (72.9) .002
4 or 5 17/20 (85.0) 13/21 (61.9) .095
Oxytocin
Yes 23/46 (50.0) 15/36 (41.7) .453
No 21/34 (61.8) 41/44 (93.2) < .001
Data are mean SD or number (percentage).
Rouzi. Hourly titrated oral misoprostol. Am J Obstet Gynecol 2014.