Safety Of Intravaginal Misoprostol Research Articles

Combined Use of Vaginal Misoprostol with Intracervical Foley Catheter Versus Vaginal Misoprostol alone in Induction of Labor at Term Pregnancy

Abstract Background Induction of labor should be used in the most efficient way possible that will result in a favorable obstetric outcome with minimum fetal morbidity. Objectives The aim of this study is to compare the efficacy and safety of intravaginal misoprostol alone versus intra cervical Foley catheter combined with vaginal misoprostol in induction of labor at term pregnancy. Methods This study was conducted at Obstetrics & Gynecology Department; Ain Shams University, Maternity Hospital in the period between May 2017 to October 2017. The total number of patients studied was 120 patients, divided into two groups; the first group (A) included 60 patients who received vaginal misoprostol, the second group (B) included 60 patients who received vaginal misoprostol combined with trans cervical Foley catheter. Results The current study found that the combined group has a better chance for NVD 88.3% versus 78.3% in misoprostol alone group, a lesser probability to CS 11.7% in combined group versus 21.7% in misoprostol alone group and a shorter induction delivery interval within 12 hours after induction (81.6% in combined group versus 59.5% in misoprostol group). Regarding the effect of both methods on fetal safety, we found that non reassuring FHR was more common in combined group 8.3% than misoprostol alone group 1.7% but it’s statistically non-significant. There was statistically significant increase in tachysystole in combined group 28.3% versus 13.3% in misoprostol alone group. However, dystocia was more common in misoprostol group 15% than combined group 3.3% that is also statistically significant. Conclusion Both methods can be used in induction of labor at term pregnancy without forgetting the precautions and close observation to the mother and the fetus. Combined method results in a shorter induction-to delivery time, but misoprostol alone was safer for the mother and the fetus.

Efficacy and safety of intravaginal misoprostol and intracervical foley's catheter ballooning in second trimester pregnancy termination

Background Termination of pregnancy in second trimester is one of the greatest challenges in modern obstetrics practice and is more risky than during first trimester. Now the main concern of the obstetrician is to provide the most effective, safest, and cost-effective regimen with least or no complications. Objective To compare the efficacy and safety of intravaginal misoprostol alone and in combination with intracervical Foley's catheter ballooning for termination of pregnancy at second trimester. Patients and methods This prospective randomized clinical study was conducted at Alzahra University Hospital and Alglaa Teaching Hospital from June 2019 till June 2020. A total of 100 pregnant women with second trimester who missed abortion were randomly divided into two groups: group I included 50 patients who received misoprostol 200-mg tab intravaginally per 6 h till maximum of four doses, in addition to intracervical Foley's catheter being placed till the catheter got expelled out spontaneously or after 24 h. Group II included 50 patients who received only misoprostol (200 μg) tab, same dose as group I. Results In this study, the success of abortion within 24 h was 42 (84%) cases in group I and 29 (58%) cases in group II. The failure of abortion after 48 h was 6% (three cases) in group I and in 18% (nine cases) in group II. The mean induction to abortion time was 14.26 h in group I and 17.243 in group II, with P value of 0.002. There was a significant decrease in the need for surgical evacuation [three (6%) cases − in group I compared with seven (14%) cases in group II]. There is no significant difference between both groups regarding complications (lower abdominal pain, postabortion bleeding, vomiting, headache, and fever); all these complications were mild. Conclusion Combined use of intravaginal misoprostol and intracervical Foley's catheter has a shorter induction to abortion time than misoprostol alone and less need for surgical evacuation, with no significant increase in adverse effects.

An Open Label, Prospective Study to Evaluate the Efficacy of Misoprostol Versus Dinoprostone Gel For Induction of Labour

Objective: This prospective study was conducted to compare the effect, efficacy & safety of intra-vaginal misoprostol (PGE1) & intra-cervical dinoprostone gel (PGE 2) for induction of labour. Methods: 60 women aged 18-35 years with single live fetus, cephalic presentation & term pregnancy, who were admitted for induction of labour were included in this study.30 women received intrvaginal 25 microgram Misoprostol (study group) & 30 women received 0.5mg of intracervical dinoprostone gel(control group). Comparison was done between the mean time taken for onset of labour, time taken for induction to delivery, mean duration of labour, requirement of Oxytocin augmentation, mode of delivery, side effects & the neonatal outcome in either of the groups. Results: The mean time taken for onset of labour was less in the misoprostol group than in the dinoprostone group (58.22 min and 1 hr 55 min). Similarly duration from induction to active phase (1hr 57 min and 4hrs 25 min) and active phase to delivery ( 3 hrs 21 min and 5 hrs 9min) was less for misoprostol group and thus the induction to delivery interval (5 hrs 18 min and 9 hrs 34 min). Cesarean section rate was less in misoprostol group (10% v/s 24%). Maternal side effects were minimal in either group & the neonatal outcome was good in both the groups. The induction cost was much less in the misoprostol group. Conclusion: Misoprostol is safe, efficacious, cheap and mother and fetus friendly drug for the induction of labour.

Foley Catheter versus Vaginal Misoprostol for Labour Induction.

Objectives. To compare the efficacy and safety of intravaginal misoprostol with transcervical Foley catheter for labour induction. Material and Methods. One hundred and four women with term gestation, with Bishop score < 4, and with various indications for labour induction were randomly divided into two groups. In Group I, 25 μg of misoprostol tablet was placed intravaginally, 4 hourly up to maximum 6 doses. In Group II, Foley catheter 16F was placed through the internal os of the cervix under aseptic condition and then inflated with 50 cc of sterile saline. Statistical analysis was done using SPSS software. Results. The induction to delivery interval was 14.03 ± 7.61 hours versus 18.40 ± 8.02 hours (p < 0.01). The rate of vaginal delivery was 76.7% versus 56.8% in misoprostol and transcervical Foley catheter group, respectively. Uterine hyperstimulation was more common with misoprostol. Neonatal outcome was similar in both the groups. Conclusion. Intravaginal misoprostol is associated with a shorter induction to delivery interval as compared to Foley's catheter and it increases the rate of vaginal delivery in cases of unripe cervix at term. Transcervical Foley catheter is associated with a lower incidence of uterine hyperstimulation during labour.

Randomized prospective trial to compare the efficacy and safety of intra-vaginal misoprostol with intra-cervical dinoprostone gel in induction of labor

Induction of labor is the intentional or artificial initiation of labor before spontaneous onset of labor. At present dinoprostone is the agent of choice but misoprostol is a potential alternative. Objectives: To compare the efficacy and safety of intravaginal misoprostol with intracervical dinoprostone in induction of labor. Materials and Methods: Two groups of 135 subjects received 0.5 mg of dinoprostone gel intracervically and tab misoprostol 25 μg digitally placed at the posterior fornix. Results: In group-one (Dinoprostone gel), 116 (85.9%) had vaginal delivery, 13 (9.6%) had ventouse delivery and six (4.4%) underwent cesarean section, whereas in group-two (Misoprostol), 118 (87.0%) and 12 (8.9%) had vaginal and ventouse delivery respectively, whereas 5 (3.7%) underwent cesarean section. Induction to delivery interval was less than 12 hours in 50% when induced with misoprostol and 33.3% with dinoprostone. Median Bishop score at the time of instillation was found to be 3 (Range 2-4) while equivalent median Bishop score for the latter group is 2 (Range 2-4) in group-one and two respectively. The difference observed was significant (P = 0.026) indicating that misoprostol improves the Bishop score more significantly than dinoprostone. No significant variation in Apgar score and maternal complications was noted in both groups. Conclusion: Both dinoprostone and misoprostol are effective agents for induction. Misoprostol with its shorter induction delivery interval, cheaper cost and less stringent storage conditions may be preferred in developing countries.

Intravaginal misoprostol alone versus intravaginal misoprostol and extraamniotic Foley catheter for second trimester pregnancy termination: an observational study.

No systematic empirical research exists addressing the question of optimal pregnancy termination method in second trimester pregnancies. The purpose of this study was to determine the efficacy and safety of intravaginal misoprostol and extraamniotic Foley catheter combination for second trimester pregnancy termination. A single center observational study was conducted in a total of 91 pregnancies. Women who met the termination of pregnancy criteria due to feto-maternal indications between 13 to 26 gestational weeks were included into the study. Study participants received intravaginal misoprostol in combination with Foley catheter (n = 46) or intravaginal misoprostol alone (n = 45). The efficacy of intravaginal misoprostol and Foley catheter insertion combination was comparable to that of intravaginal misoprostol alone in terms of time to abortion/birth [median (95% Confidential Interval [95% CI]): 14.33 (11.33-17.25) hours and 12.08 (9.50-15.33) hours, respectively Hazard Ratio: 0.73, 95% CI: 0.47 to 1.12, p = 0.14 (log-rank)]. The only serious maternal event was uterine rupture observed in one woman in Foley combination group. The combination of intravaginal misoprostol and extraamniotic Foley catheter for second trimester pregnancy termination does not provide additional efficacy.

A Randomised Controlled Trial Comparing Intravaginal Misoprostol and Intracervical Dinoprostone in Pre Induction Cervical Ripening

Objective: To compare the efficacy and safety of intravaginal misoprostol with intracervical dinoprostone for preinduction cervical ripening. Material andMethods: It was a randomized controlled trial conducted at department of obstetrics and gynecology, JIPMER, Puducherry. Three hundred women with Bishop score of 6, were assigned randomly to receive either intravaginal misoprostol 25 μg every four hours for four doses, and intracervical dinoprostone gel 0.5 mg every eight hours for two doses. (one hundred women in each group). Oxytocin was initiated as per standardized protocol, if the cervix was favourable. If the cervical ripening was unsuccessful (Bishop score 6) after the maximum doses of drugs in both the groups, then further treatment was individualized. Efficacy and cost of the drugs were compared in both groups. Results: Primary outcome measure was change in Bishop score. Mean Bishop score change at the end of 16 hours was significantly higher in the misoprostol group, (2.57±0.59) compared to dinoprostone group (2.17±0.10, p=0.016). This finding was inspite of the fact that the dinoprostone group had higher Bishop score prior to the ripening.(3.55±0.56 vs 3.28±0.77, p=0.006). Secondary outcome measures such as mean intervention-delivery interval, oxytocin requirement, mode of delivery, maternal and neonatal outcomes were similar in both the groups. Overall mean cost of ripening agent per patient was significantly less in the misoprostol group, (22.56±93.16 rupees) compared to dinoprostone group (493.89±173.99 rupees, p0.0001).Conclusion: Low dose misoprostol is as effective as dinoprostone in cervical ripening and demonstrates similar fetal and maternal safety profile.

Misoprostol v/s Cerviprime Gel for Induction of Labour

Objective: This prospective study was conducted to compare the effect, efficacy &amp; safety of intra-vaginal misoprostol (PGE 1) &amp; intra-cervical dinoprostone gel (PGE 2) for induction of labour. Methods: 100 women aged 16-35 years with single live fetus, cephalic presentation &amp; term pregnancy, who were admitted for induction of labour were included in this study. 50women received intrvaginal 50 microgram Misoprostol (study group) &amp; 50 women received 0.5mg of intracervical dinoprostone gel (control group). Comparison was done between the mean time taken for onset of labour, time taken for induction to delivery, mean duration of labour, requirement of Oxytocin augmentation, mode of delivery, side effects &amp; the neonatal outcome in either of the groups. Results: The mean time taken for onset of labour was less in the misoprostol group than in the dinoprostone group (43.22 min v/s 1 hr 40 min). Similarly duration from induction to active phase (1hr 42 min v/s 4hrs 10 min)and active phase to delivery ( 3 hrs 06 min v/s 4 hrs 54 min) was less for misoprostol group and thus the induction to delivery interval (5 hrs 02 min v/s 11hrs 12 min). None of the study group patients required Oxytocin augmentation. Cesarean section rate was less in misoprostol group (6% v/s 22%). Maternal side effects were minimal in either group &amp; the neonatal outcome was good in both the groups. The induction cost was much less in the misoprostol group. Conclusion: Misoprostol is safe, efficacious, cheap and mother and fetus friendly drug for the induction of labour.

Induction of Labor: A Comparative Study of Intravaginal Misoprostol and Dinoprostone

To compare the efficacy and safety of intravaginal misoprostol and dinoprostone for elective induction of labor in nulliparous women with an unfavorable cervix. A quasi-experimental study was conducted in Bahawal Victoria Hospital, Bahawalpur, Pakistan, from July 1, 2005 to August 31, 2006. A total of 120 primigravid women with gestational ages of > 40 weeks to < 42 weeks were divided into two groups. Group A (n = 60) was given 50 microg of misoprostol and Group B (n = 60) was given 3 mg of dinoprostone every 6 hours, for a maximum of three doses. The induction to onset of significant uterine contractions and delivery intervals were lower in Group A than in Group B (6.1 vs. 7.2 hours; p = 0.16; and 8.2 vs. 11.0 hours; p = 0.007, respectively). Group A had a lower cesarean section rate than Group B (7% vs. 30%; p = 0.003), but a higher rate of uterine hyperstimulation (10% vs. 3%; p = 0.16), tachysystole (17% vs. 3%; p = 0.02), and neonatal admissions to the intensive care unit within 24 hours of delivery (4 vs. 3; p = 0.71) and after 24 hours (2 vs. 1; p = 0.56) than Group B. Vaginal misoprostol is more effective than dinoprostone for the elective induction of labor beyond 40 weeks of gestation, but is associated with more uterine hyperstimulation, tachysystole, and neonatal intensive care unit admissions.

Prospective randomised controlled trial to compare safety and efficacy of intravaginal Misoprostol with intracervical Cerviprime for induction of labour with unfavourable cervix

SummaryA randomised prospective trial was carried out to compare the efficacy and safety of intravaginal Misoprostol with intracervical dinoprostone gel for induction of labour in cases of unfavourable cervix. One hundred women with an unfavourable cervix requiring induction of labour were randomised to receive either 25 µm vaginal Misoprostol 4-hourly or 0.5 mg of intracervical dinoprostone 12 hourly. The outcome measured was change in Bishop's score, percentage of women going into labour, induction to delivery interval, need for oxytocin, mode of delivery and complications. The parity, mean period of gestation and Bishop's score were similar in both the groups. The improvement in Bishop's score at 12 h was significantly better in the Misoprostol group. Induction to delivery interval was shorter in the Misoprostol group, 16.59 ± 5.13 h vs 27.77 ± 12.71 h. The rate of complications was comparable. Vaginal Misoprostol 25 µg 4-hourly is safe and effective for induction of labour with shorter induction to delivery interval.

Randomized comparison between intravaginal misoprostol and dinoprostone for cervical ripening and induction of labor

Objective: We sought to evaluate the efficacy and safety of intravaginal misoprostol and dinoprostone for labor induction. Study Design: One hundred eighty-nine women with singleton term pregnancies and unfavorable cervices were randomly assigned to receive intravaginal misoprostol or dinoprostone. The outcome variables were change in Bishop score, time from application to active phase of labor and delivery, fetal and maternal morbidity, and the incidence of cesarean deliveries. Results: The interval from application of the initial dose to the beginning of the active phase of labor was 9.8 ± 5.8 and 14.2 ± 10.2 hours ( P < .01), and the interval from initial dose to delivery was 15.3 ± 9.8 and 19.1 ± 13.2 hours ( P = .027) for the misoprostol and dinoprostone groups, respectively. There were no significant differences in Bishop score change, cesarean delivery rate, and the incidence of tachysystole, hypersystole, and hyperstimulation. No maternal and neonatal adverse effects were noted. Conclusion: Intravaginal misoprostol is more effective than intravaginal dinoprostone for labor induction in low-risk patients at term with unfavorable cervices. (Am J Obstet Gynecol 1999;181:626-9.)