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Original ArticleOpen Access
A Randomized Comparison of One Single Dose of Vaginal 50 ug Misoprostol with 3 mg Dinoprostone in Pre-Induction Cervical Ripening
Charoenkul S 
,
Sripramote M
,
Sripramote M SUNTANA CHAROENKUL, M.D.*,
MANIT SRIPRAMOTE, M.D.*
Objective:
To compare the efficacy and safety of one single dose of 50 J.lg misoprostol
to one single dose of 3 mg dinoprostone administered vaginally for pre-induction cervical ripen-
Ing m term-pregnant women, who had indications for induction of labor with unripe cerv1ces.
Study design:
A randomized double-blind controlled trial.
Setting:
Bangkok Metropolitan Administration Medical College and Vajira Hospital,
Bangkok, Thailand.
Subjects:
One hundred and forty-three singleton pregnant women of;::: 37 weeks of ges-
tation, who had indications for termination of pregnancy. All patients had a Bishop score of 0-6,
without contraindications for labor induction.
Intervention:
The subjects were stratified by parity to nullipara and multipara group.
The subjects in each stratum were allocated by randomization to receive a single dose of 50 J.lg
misoprostol or 3 mg dinoprostone, administered vaginally. Twenty-four hours after medication,
oxytocin augmentation was given to both groups.
Main outcome measure:
The Bishop score of cervix at 24 hours after insertion of the
studied drugs, the occurrence of abnormal uterine contraction, and the number of vaginal deliveries
within 24, 48 hours.
Results:
The demographic data and the initial Bishop score (median score 3.5
versus
4.0)
were comparable in both groups. The change of score at 24 hours was one unit higher in
misoprostol-treated patients compared with dinoprostone-treated patients (mean change score 6.5
versus
5.5, with 95 per cent CI 0.04 to 2.1, p=0.042) but was not of clinical importance. There was a
higher frequency of hyperstimulation syndrome in the misoprostol group (6.9%
vs
0%) during 8
hours of cervical ripening. Although the difference was not statistically significant (p=0.058 ). it
was clinically important. Comparing vaginal deliveries between the misoprostol and dinoprostone
groups, the frequencies of delivery within 24 hours were 46.3 per cent
versus
35.7 per cent
(p=0.350), and within 48 hours were 88.9 per cent
versus
89.3 per cent (p>0.05), non-significantly
different. No significant differences were noted between misoprostol and dinoprostone in terms
of interval from start of medication to vaginal delivery and neonatal outcomes.
*
Department of Obstetrics and Gynecology, Bangkok Metropolitan Administration Medical College and Yajira
Hospital, Bangkok 10300, Thailand.
Vol.83 No.9
COMPARISON OF VAGINAL MISOPROSTOL WITH DINOPROSTONE
1027
Conclusion: The efficacy of a single 50 J..lg dose of vaginally administered misoprostol.
is not clinically different to 3 mg dinoprostone in cervical ripening. Although the study was not
sufficiently large to detect the differences in abnormal uterine contractions between the two
groups, there was a higher frequency of hyperstimulation syndrome in the misoprostol group
compared to the dinoprostone group. Close utero-fetal monitoring in misoprostol-treated patients is
needed.
Key word : Pre-induction Cervical Ripening, Misoprostol, Dinoprostone
MANIT SRIPRAMOTE, M.D.*
Objective:
To compare the efficacy and safety of one single dose of 50 J.lg misoprostol
to one single dose of 3 mg dinoprostone administered vaginally for pre-induction cervical ripen-
Ing m term-pregnant women, who had indications for induction of labor with unripe cerv1ces.
Study design:
A randomized double-blind controlled trial.
Setting:
Bangkok Metropolitan Administration Medical College and Vajira Hospital,
Bangkok, Thailand.
Subjects:
One hundred and forty-three singleton pregnant women of;::: 37 weeks of ges-
tation, who had indications for termination of pregnancy. All patients had a Bishop score of 0-6,
without contraindications for labor induction.
Intervention:
The subjects were stratified by parity to nullipara and multipara group.
The subjects in each stratum were allocated by randomization to receive a single dose of 50 J.lg
misoprostol or 3 mg dinoprostone, administered vaginally. Twenty-four hours after medication,
oxytocin augmentation was given to both groups.
Main outcome measure:
The Bishop score of cervix at 24 hours after insertion of the
studied drugs, the occurrence of abnormal uterine contraction, and the number of vaginal deliveries
within 24, 48 hours.
Results:
The demographic data and the initial Bishop score (median score 3.5
versus
4.0)
were comparable in both groups. The change of score at 24 hours was one unit higher in
misoprostol-treated patients compared with dinoprostone-treated patients (mean change score 6.5
versus
5.5, with 95 per cent CI 0.04 to 2.1, p=0.042) but was not of clinical importance. There was a
higher frequency of hyperstimulation syndrome in the misoprostol group (6.9%
vs
0%) during 8
hours of cervical ripening. Although the difference was not statistically significant (p=0.058 ). it
was clinically important. Comparing vaginal deliveries between the misoprostol and dinoprostone
groups, the frequencies of delivery within 24 hours were 46.3 per cent
versus
35.7 per cent
(p=0.350), and within 48 hours were 88.9 per cent
versus
89.3 per cent (p>0.05), non-significantly
different. No significant differences were noted between misoprostol and dinoprostone in terms
of interval from start of medication to vaginal delivery and neonatal outcomes.
*
Department of Obstetrics and Gynecology, Bangkok Metropolitan Administration Medical College and Yajira
Hospital, Bangkok 10300, Thailand.
Vol.83 No.9
COMPARISON OF VAGINAL MISOPROSTOL WITH DINOPROSTONE
1027
Conclusion: The efficacy of a single 50 J..lg dose of vaginally administered misoprostol.
is not clinically different to 3 mg dinoprostone in cervical ripening. Although the study was not
sufficiently large to detect the differences in abnormal uterine contractions between the two
groups, there was a higher frequency of hyperstimulation syndrome in the misoprostol group
compared to the dinoprostone group. Close utero-fetal monitoring in misoprostol-treated patients is
needed.
Key word : Pre-induction Cervical Ripening, Misoprostol, Dinoprostone
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