scholarly journals Cervical Versus Vaginal, and Sublingual Misoprostol for Labor Induction at Term Parturient: a Randomized Double-blind Clinical Trial

Author(s):  
Mahtab Dadashaliha ◽  
Somayeh Fallah ◽  
Monirsadat Mirzadeh

Abstract Background: The study will attempt to evaluate the safety and effectiveness of intracervical misoprostol in comparison with intravaginal and sublingual for the induction of labor at term. Methods: three hundred term pregnancies requiring induction of labor were treated with 50μg of misoprostol intracervical, sublingual and vaginal. Participants were randomly allocated into three groups of 100. The dose was repeated every 4 hours until adequate uterine contraction and Bishop score were achieved. The duration of induction to delivery, time to active phase, the rate of delivery, and the need for cesarean section were compared in three groups. Additionally, labor course and side effects were recorded and analyzed.Results: Labor was successfully induced in all cases, most (63%) of which required a single dose of misoprostol. Ninety-three (93.0%) cervical patients proceeded to spontaneous vaginal delivery, also this figure was the same in the vaginal and sublingual group 83 (83.0%), The other 41 cases received cesarean delivery with more indications failure to progress and meconium-stained liquor. The results showed that 278 (92.7%) deliveries were achieved in less than 10 hours. Time from start of medication to the active phase of labor and delivery were 3.01 ± 0.86 and 6.1 ± 1.3 hours in the Cervical group, 4.2 ± 0.66 and 8.4 ± 0.92 hours in the sublingual group, and 5.06 ± 1.1 and 9.2 ± 1.5 hours in the vaginal group respectively (p<0.001). Cesarean rate was lower in the cervical group than the two other groups (p=0.05). No significant differences were observed between the study groups in terms of Apgar score and meconium-stained amniotic fluid. Moreover, no maternal and neonatal complication were seen.Conclusion: In addition to the sublingual and intravaginal routes of administration, intracervical misoprostol at a single dose of 50μg appears to be an effective method for induction of labor in women with an unfavorable cervix. Similar to all medical interventions, a discussion of the risks, benefits, and alternatives to induction of labor with this medication in each individual woman should be undertaken prior to treatment. Trial registration: This clinical study was approved by the Iranian Registry of Clinical Trials (http://www.irct.ir) with the IRCT ID: IRCT20190415043278N1, Registration and approval date was 2019-05-13 and 2019-05-27 respectively.

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Masoumeh Dadashaliha ◽  
Somayeh Fallah ◽  
Monirsadat Mirzadeh

Abstract Background This study attempts to evaluate the safety and effectiveness of 50μgm intracervical misoprostol in comparison with intravaginal and sublingual for the induction of labor at term pregnant women. Methods This study is designed as a parallel clinical trial study. Three hundred and fifteen term pregnancies requiring induction of labor were treated with the maximum used misoprostol intracervical, sublingual, and vaginal doses. Participants were randomly allocated into three groups of 105. The dose was repeated every 4 h until adequate uterine contraction and Bishop Score were achieved. The duration of induction to births, time to the active phase, the rate of births, and the need for caesarean section were compared in three groups. Additionally, labor course and side effects were recorded and analyzed. Data were analyzed using SPSS software. A significance level of p <  0.05 was considered for statistical analyses. Findings Labor was successfully induced in all cases most (63%) of which required a single dose of misoprostol. Ninety-three (93.0%, p <  0.05) cervical participants proceeded to vaginal births. This figure was also the same in the vaginal and sublingual group of 83 cases (83.0%). The other 41 cases received caesarean section with more indications of failure to progress and meconium-stained liquor. The results indicated that 278 (92.7%) births were achieved in less than 10 h. Time from start of medication to the active phase of labor and childbirth was 3.01 ± 0.86 and 6.1 ± 1.3 h in the Cervical group, 4.2 ± 0.66 and 8.4 ± 0.92 h in the sublingual group, and 5.06 ± 1.1 and 9.2 ± 1.5 h in the vaginal group respectively (p < 0.001). The Caesarean rate was lower in the cervical group than in the two other groups (p = 0.05). No significant differences were observed between the study groups in terms of Apgar score and meconium-stained amniotic fluid. Furthermore, no maternal and neonatal complications were observed. Conclusion In addition to the sublingual and intravaginal routes of administration, intracervical misoprostol at a single dose of 50μgm appears to be an effective method for induction of labor in women with an unfavorable cervix. Like all medical interventions, a discussion of the risks, benefits, and alternatives to induction of labor with this medication in each woman should be undertaken before treatment. Trial registration This clinical study was approved by the Iranian Registry of Clinical Trials with IRCT ID: IRCT20190415043278N1. Registration date was on May 13, 2019 and May 27, 2019 respectively (http://www.irct.ir).


Author(s):  
Shikha Yadav ◽  
Nootan Chandwaskar

Background: Both Prostaglandin E1 and E2 analog are being used for cervical ripening. The aims of study was to compare the efficacy and safety profile of sublingual misoprostol (PGE2) and intracervical dinoprostone (PGE1) for cervical ripening and induction of labor.Methods: One hundred women with single live fetus and with gestational age of more than 37 weeks admitted for induction of labor were recruited for the study. Patients were randomized to receive either 25μg of misoprostol sublingually or dinaprostone gel (0.5mg) intracervically.Results: There was shorter induction to active phase, induction to delivery time intervals and less requirement of oxytocin augmentation in misoprostol group than dinoprostone gel group. Incidence of tachysystole was higher in misoprostol group than dinoprostone gel group (22% vs 10%) however this was not statistically significant. Mode of delivery, maternal and neonatal complications were similar in both the groups.Conclusions: Use of misoprostol in lower dose is a safe and cost-effective method for cervical ripening and induction of labor.


2013 ◽  
Vol 207 (6) ◽  
pp. 957-965 ◽  
Author(s):  
Anna P. Durbin ◽  
Beth D. Kirkpatrick ◽  
Kristen K. Pierce ◽  
Daniel Elwood ◽  
Catherine J. Larsson ◽  
...  

Author(s):  
Marcus Cavalcante de Oliveira Araújo ◽  
Juliana Alves de Sousa Caixeta ◽  
Breno Fernandes Vilarinho ◽  
Melissa Ameloti Gomes Avelino

PEDIATRICS ◽  
1993 ◽  
Vol 91 (1) ◽  
pp. 23-30
Author(s):  
Steven M. Green ◽  
Steven G. Rothrock

This study evaluated the efficacy of a single dose of intramuscular ceftriaxone for acute otitis media in children, using amoxicillin as a control. (There is currently no established single-dose treatment for this condition.) In a prospective, randomized, double-blind, clinical trial, 233 children, aged 5 months to 5 years, with uncomplicated acute otitis media were randomly assigned to receive either a single intramuscular injection of ceftriaxone (50 mg/kg) plus placebo oral suspension for 10 days, or a placebo injection plus amoxicillin oral suspension (40 mg/kg per day divided three times per day) for 10 days in a double-blind fashion. Demographic and clinical characteristics were similar in both groups. Treatment was successful in 107 of 117 given amoxicillin (91%, 95% confidence interval 86% to 97%) and 105 of 116 given ceftriaxone (91%, 95% confidence interval 85% to 96%). Rates of improvement, failure, relapse, and reinfection were similar in both groups, as were the otoscopic and tympanometric evaluations at the 14- and 60-day follow-up visits. It is concluded that a single intramuscular injection of ceftriaxone (50 mg/kg) is as effective as 10 days of oral amoxicillin for the treatment of uncomplicated acute otitis media in children.


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