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Misoprostol administered sublingually at a dose of 12.5??g versus vaginally at a dose of 25??g for the induction of full-term labor: a randomized controlled trial.

ABSTRACT: BACKGROUND:Labor induction is defined as any procedure that stimulates uterine contractions before labor begins spontaneously. The vaginal and oral routes of administration of misoprostol are those most used for the induction of labor in routine practice, with the recommended dose being 25??g. Nevertheless, the sublingual route may reduce the number of vaginal examinations required, increasing patient comfort and lowering the risk of maternal and fetal infection. Based on a previous systematic review, the objective of this study was to compare the frequency of tachysystole as the main outcome measure when misoprostol is administered sublingually at the dose of 12.5??g versus vaginally at a dose of 25??g to induce labor in a full-term pregnancy with a live fetus. METHODS:A randomized, placebo-controlled, triple-blind clinical trial was conducted at two maternity hospitals in northeastern Brazil. Two hundred patients with a full-term pregnancy, a live fetus, Bishop score???6 and an indication for induction of labor were included. Following randomization, one group received 12.5??g misoprostol sublingually and a vaginal placebo, while the other group received a sublingual placebo and 25??g misoprostol vaginally. The primary outcome was the frequency of tachysystole. Student's t-test, the chi-square test of association and Fisher's exact test were used, as appropriate. Risk ratios and their 95% confidence intervals were calculated. RESULTS:The frequency of tachysystole was lower in the group using 12.5??g misoprostol sublingually compared to the group using 25??g misoprostol vaginally (RR?=?0.15; 95%CI: 0.02-0.97; p?=?0.002). Failure to achieve vaginal delivery within 12 and 24?h was similar in both groups. Sublingual administration was preferred to vaginal administration by women in both groups; however, the difference was not statistically significant. CONCLUSION:The effectiveness of labor induction with low-dose sublingual misoprostol was similar to that achieved with vaginal administration of the recommended dose; however, the rate of tachysystole was lower in the sublingual group, and this route of administration may prove a safe alternative. TRIAL REGISTRATION:Registration number: NCT01406392, ClinicalTrials.gov. Date of registration: August 1, 2011.

SUBMITTER: Gattas DSMB

PROVIDER: S-EPMC7147027 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Misoprostol administered sublingually at a dose of 12.5 μg versus vaginally at a dose of 25 μg for the induction of full-term labor: a randomized controlled trial.

Gattás Daniele S M B DSMB de Amorim Melania M R MMR Feitosa Francisco E L FEL da Silva-Junior José R JR Ribeiro Lívia C G LCG Souza Gustavo F A GFA Souza Alex S R ASR

Reproductive health 20200410 1

<h4>Background</h4>Labor induction is defined as any procedure that stimulates uterine contractions before labor begins spontaneously. The vaginal and oral routes of administration of misoprostol are those most used for the induction of labor in routine practice, with the recommended dose being 25 μg. Nevertheless, the sublingual route may reduce the number of vaginal examinations required, increasing patient comfort and lowering the risk of maternal and fetal infection. Based on a previous syst ...[more]

PMID: 32272959

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Project description:BACKGROUNDVarious methods are currently used for the induction of labor. Nevertheless, the most effective method with the fewest side effects remains to be established. Misoprostol, administered vaginally, has been routinely used for this purpose; however, other forms of administration are being proposed, including the use of sublingual tablets. No studies have yet compared the effectiveness and safety of 12.5-?g misoprostol administered sublingually compared to a 25-?g vaginal dose of the drug for the induction of labor.METHODSA triple-blind, multicenter, placebo-controlled, randomized clinical trial will be conducted in Brazil at the Instituto de Medicina Integral Prof. Fernando Figueira and at the Assis Chateaubriand Maternity Teaching Hospital of the Federal University of Ceará. A total of 140 patients with full-term pregnancies, a live fetus, a Bishop score???6 and a recommendation of induction of labor will be randomized to one of two groups. One group will receive 12.5-?g sublingual tablets of misoprostol and placebo vaginal tablets, while the other group will receive placebo sublingual tablets and vaginal tablets containing 25 ?g of misoprostol. The principal endpoint is the rate of tachysystole. The secondary endpoints are vaginal delivery within 24 h of induction, uterine hyperstimulation, Cesarean section, severe neonatal morbidity or perinatal death, severe maternal morbidity or maternal death, and maternal preference regarding the route of administration of the drug. Student's t-test, and the chi-square test of association or Fisher's exact test, as appropriate, will be used in the data analysis. Risk ratios and their respective 95% confidence intervals will be calculated.DISCUSSIONMisoprostol has been identified as a safe, inexpensive, easily administered option for the induction of labor, with satisfactory results. An experimental study has shown that misoprostol administered sublingually at a dose of 25 ?g appears to be effective and is associated with greater maternal satisfaction when labor is induced in women with an unfavorable cervix. Nevertheless, the rate of tachysystole remains high; therefore, further studies are required to determine the ideal dose and the ideal interval of time between doses.TRIAL REGISTRATIONClinicalTrial.gov, NCT01406392 .

Project description:ObjectiveTo evaluate whether cervical ripening with oral misoprostol increases cesarean delivery risk and prolongs time to vaginal delivery compared with vaginal misoprostol in a predominantly overweight population.MethodsThis single center, retrospective cohort study was performed at a tertiary care academic medical center and compared labor induction outcomes with vaginal misoprostol to outcomes with oral misoprostol after a complete institutional shift to oral misoprostol. Labor induction using 25 micrograms vaginal misoprostol in 2013-2014 was compared with 50 micrograms oral misoprostol in 2014-2015. The primary outcome was cesarean delivery. Secondary outcomes included time to vaginal delivery, uterine tachysystole, maternal hemorrhage, and composite adverse neonatal outcomes. Demographics and outcomes were analyzed using standard statistical tests. Multivariable regression models accounting for potential confounders were created for the primary and secondary outcomes with adjusted odds ratios (aOR) as the measures of effect.ResultsThere were 138 women in the oral and 138 women in the vaginal misoprostol groups. In the overall cohort, the median (interquartile range) body mass index was 31.7 (28.2-36.8) and most women (72%) were of either black or Hispanic race or ethnicity. The frequency of cesarean delivery was higher in the oral than the vaginal misoprostol group (32% vs 21%; P=.04). The adjusted odds of cesarean was higher with oral misoprostol (aOR 2.01; 95% CI 1.07-3.76). Among nulliparous women, the frequency of cesarean delivery was 41% in the oral and 28% in the vaginal misoprostol groups (aOR 2.79; 95% CI 1.26-6.19). Women had a longer time to vaginal delivery in the oral compared with vaginal misoprostol group (41 vs 31 hours respectively, P=.01). Tachysystole occurred more frequently with vaginal misoprostol (20% vs 11%; P=.04).ConclusionCompared with vaginal misoprostol, oral misoprostol may be associated with increased risk of cesarean delivery and longer time to vaginal delivery.

Project description:ImportanceQuantification of potential consequences associated with the use of epidural analgesia during labor could help to improve the safety and quality of labor and delivery care for parturient women.ObjectiveTo evaluate the association between epidural analgesia use during labor and neonatal infection in a large cohort of parturient women.Design, setting, and participantsThis propensity score-matched cohort study was conducted at a university-affiliated hospital in Shanghai, China. Women at full-term pregnancy undergoing vaginal delivery between January 2013 and October 2018 were included in the study. Parturient women who were parous, experiencing premature delivery (gestational age <37 weeks), were pregnant with more than 1 fetus, or had experienced a stillbirth were excluded. Data were analyzed from October 2019 to June 2020.ExposuresThe use of epidural analgesia during labor.Main outcomes and measuresThe primary outcome was the incidence of neonatal infection, including neonatal sepsis, neonatal uncharacterized infection, neonatal pneumonia, and neonatal necrotizing enterocolitis reported in the medical record. Secondary outcomes included the incidence of maternal intrapartum fever and histologic chorioamnionitis.ResultsAmong 37 786 parturient women included (mean [SD] age, 29.5 [3.0] years), 19 968 (52.8%) received epidural analgesia during labor. In the propensity score-matched cohort (including 15 401 parturient women in each group), use of epidural analgesia was associated with a higher incidence of neonatal infection (absolute risk difference, 2.6%, 95% CI, 2.2%-3.0%; relative risk [RR], 2.43; 95% CI, 2.11-2.78), including higher incidence of sepsis (absolute risk difference, 0.1%, 95% CI, 0.1%-0.2%; RR, 3.50; 95% CI, 1.73-7.07) and uncharacterized infection (absolute risk difference, 2.2%, 95% CI, 1.9% to 2.6%; RR, 2.69; 95% CI, 2.30-3.15), compared with no epidural analgesia use. Use of epidural analgesia was also associated with greater incidence of maternal intrapartum fever (RR, 4.12; 95% CI, 3.78-4.50) and histologic chorioamnionitis (RR, 4.08; 95% CI, 3.59-4.64) compared with no epidural analgesia use.Conclusions and relevanceThis cohort study found that use of epidural analgesia in full-term nulliparous women undergoing vaginal delivery was associated with an increased risk of neonatal infection, pending further investigation. These findings support efforts to further improve safety and quality of labor and delivery care for parturient women.

Project description:BackgroundInduction of labor occurs in greater than 22% of all pregnancies in the United States. Previous studies have shown that misoprostol is more effective for induction than oxytocin or dinoprostone alone. The World Health Organization recommends vaginal misoprostol 25mcg every 6 hours and the American Congress of Obstetricians and Gynecologists recommends 25mcg vaginal misoprostol every three to 6 hours. Although route of administration and dosage of misoprostol has been extensively studied, little is known about the optimal dosing interval of vaginal misoprostol.MethodsThe primary objective of this study is to determine the effect of delayed vaginal misoprostol dosing, defined as any interval longer than 4.5 h, on time to vaginal delivery. Our hypothesis is that the routine dosing interval of 4 hours shortens times to vaginal delivery compared to delayed dosing, even when adjusted for the time of delay. Secondary objectives include the effect of delayed vaginal misoprostol dosing on cesarean section rate, operative vaginal delivery rate, maternal outcomes, and neonatal outcomes. We conducted a retrospective chart review of 323 inductions of labor at one academic institution. The primary outcome was the proportion of patients who achieved a vaginal delivery within 24 h. The group who received all doses of misoprostol within a 4.5 h dosing window (Routine Dosing Interval Group) was compared with the group who had any dosing deviation (Delayed Dosing Interval Group).ResultsOf 133 included patients, 64 subjects received routine interval dosing and 69 subjects received delayed interval dosing. The vaginal delivery rates within 24 h were 56% (36/64) and 20% (14/69), respectively (P < 10- 4). Spontaneous vaginal delivery rates were 86% (55/64) vs. 75% (52/69), respectively (P = .13). Kaplan Meier curves demonstrated statistically significant difference in time to vaginal delivery between groups, with a Cox Proportional Hazard ratio for routine dosing interval of 1.73 (P < 10- 5) unadjusted and 1.34 (P = .01) when adjusted for dosing delay.ConclusionsThis retrospective study demonstrates a significant increase in delay-adjusted time to vaginal delivery when doses of vaginal misoprostol are delayed past 4.5 h.

Project description:BackgroundThe Induction of labor is the most common obstetric procedure in daily practice. Introducing propranolol as a new drug to augment the action of prostaglandins will help in the induction process and decrease CS rates. Several researchers have used propranolol in the augmentation of labor.AimThis pilot study compares propranolol and misoprostol versus misoprostol alone for labor induction in primigravids.MethodsThis is a Randomized clinical trial, single-blinded, placebo-controlled trial at Ain Shams University Maternity hospital. This study included 128 pregnant full-term primigravid women candidates for labor induction, randomized into two groups. All candidates underwent labor induction with 25 µg of vaginal misoprostol. Group I received 20 mg of oral propranolol tablets, while group II received sugary pills as a placebo. Candidates who responded successfully to induction were assessed for possible augmentation of labor by amniotomy or oxytocin infusion. The Primary outcome was induction to delivery interval, while the secondary outcomes were the duration of the latent phase, mode of delivery, and APGAR score of the neonate.ResultsThe induction-delivery time was (11.8 ± 8.1 h. vs. 12.6 ± 8.9 h., P value = 0.027) and the duration of the latent phase of labor (7.9 ± 5.6 h. vs. 9.2 ± 6.03 h., P value = 0.017) were significantly shorter in the group of misoprostol and propranolol compared to the group of misoprostol and placebo. There was no statistically significant difference between both groups' mode of delivery, indications for cesarean section, misoprostol, and oxytocin doses, or neonatal outcome. (P value > 0.05).ConclusionPropranolol, when used with misoprostol for induction of labor, results in augmentation of action of misoprostol and a significantly shorter induction-delivery interval.Trial registrationWe retrospectively registered this trial in clinicaltrial.gov on 01/09/2020 (NCT04533841). https://clinicaltrials.gov/ct2/show/NCT04533841.

Dataset Information

Misoprostol administered sublingually at a dose of 12.5??g versus vaginally at a dose of 25??g for the induction of full-term labor: a randomized controlled trial.

Publications

Misoprostol administered sublingually at a dose of 12.5 μg versus vaginally at a dose of 25 μg for the induction of full-term labor: a randomized controlled trial.

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