Is rectal misoprostol really effective in the treatment of third stage of labor? A randomized controlled trial

OBJECTIVE: The purpose of this study was to compare misoprostol 600 microg intrarectally with conventional oxytocics in the treatment of third stage of labor. STUDY DESIGN: In a controlled trial, 1606 women were randomly grouped to receive (1) oxytocin 10 IU plus rectal misoprostol, (2) rectal misoprostol, (3) oxytocin 10 IU, and (4) oxytocin 10 IU plus methylergometrine. The main outcome measures were the incidence of postpartum hemorrhage and a drop in hemoglobin concentration from before delivery to 24 hours after delivery. RESULTS: The incidence of postpartum hemorrhage was 9.8% in the group that received only rectal misoprostol therapy compared with 3.5% in the group that received oxytocin and methylergometrine therapy (P =.001). There were no significant differences among the 4 groups with regard to a drop in hemoglobin concentrations. Significantly more women needed additional oxytocin in the group that received only rectal misoprostol therapy, when compared with the group that received oxytocin and methylergometrine therapy (8.3% vs 2.2%; P <.001). The primary outcome measures were similar in the group that received only rectal misoprostol therapy and the group that received only oxytocin therapy. CONCLUSION: Rectal misoprostol is significantly less effective than oxytocin plus methylergometrine for the prevention of postpartum hemorrhage.     

Comparative study of the outcome of induction of labor using 25 µg and 50 µg of vaginal misoprostol

Objective: To compare the safety and effectiveness of vaginal misoprostol 25 μg with those of 50 μg in induction of labor. Method: One hundred and sixty eligible women of low parity with indications for induction of labor at term were enrolled for the study. The subjects were randomized into two groups of vaginal misoprostol 25 µg and 50 µg dose regimens. Maternal characteristics, labor and newborn outcome were compared. Results: The total duration of labor was significantly shorter in the 50 µg group (8.24?±?1.5?h) than 25 µg group (9.09?±?2.7?h), p = 0.02. Oxytocin augmentation was significantly higher in the 25 µg group (18.75%) than in the 50 µg group (7.5%), p = 0.04. The indications for caesarean section were significantly different, (p = 0.02) between the two groups although the incidence was similar. The intrapartum adverse effects like fetal distress, meconium stained liquor, and tachysystole were significantly higher in the 50 µg group, p = 0.003. Similarly, the postpartum adverse effects such as cervical and vaginal tears were significantly higher in 50 µg group, p = 0.01. Conclusion: The two dose regimens were both effective in induction of labor, but 50 µg dose regimen resulted in significantly shorter duration of labor but with higher rate of labor complications than the 25 µg dose regimen.     

Ethinyl estradiol 20 μg/drospirenone 3 mg 24/4 oral contraceptive for the treatment of functional impairment in women with premenstrual dysphoric disorder

Objective

To determine the effects of ethinyl estradiol (EE)/drospirenone in a 24/4 regimen (24 days of active and 4 days of inactive pills) on functional impairment (affecting work, partnership, and social activities) in women with premenstrual dysphoric disorder (PMDD).

Methods

The present study was a secondary analysis of a double-blind, randomized, parallel-design multicenter trial. Women received EE 20 μg/drospirenone 3 mg (n = 232) or placebo (n = 218) and completed the Daily Record of Severity of Problems (DRSP) scale daily.

Results

The decrease in mean scores for all 3 DRSP functional impairment items (work, partnership, and social activities) from baseline to cycle 3 mirrored changes in the total DRSP symptom score; the greatest decreases were observed in cycle 1 with further small reductions through to cycle 3. The proportional mean decreases from baseline to cycle 1 for the 3 functional items ranged from 47% to 48%. For all 3 functional items, the mean reductions from baseline to cycle 1 (but not from cycle 1 to cycles 2 and 3) were significantly greater with EE/drospirenone than with placebo (P < 0.05).

Conclusion

Ethinyl estradiol 20 μg/drospirenone 3 mg in a 24/4 regimen significantly improved functional impairment in women with PMDD. Symptoms improved in parallel.     

Ensayo clínico aleatorizado para evaluar la eficacia y seguridad de la administración de 25 μg de misoprostol por vía vaginal frente a 50 μg por vía sublingual para la inducción del trabajo del parto en gestantes con diabetes

Objective

To evaluate the safety and efficacy of misoprostol 50 μg administered sublingually versus 25 μg administered vaginally for labor induction at term in pregnant women with diabetes.

Methods

Three hundred pregnant women with diabetes were randomly allocated to receive misoprostol 25 μg vaginally or 50 μg sublingually every 4 hours up to 4 doses. The main variable assessed was the rate of vaginal deliveries in 24 hours.

Results

Vaginal delivery in 24 hours was achieved in 109/150 (72.7%) women in the sublingual group and in 104/150 (69.3%) in the vaginal group, with no statistically significant differences (p = 0.611; RR = 1.176; 95% CI for RR, 0.714-1.938). Tachysystole was significantly more frequent in the sublingual misoprostol group (RR = 0.474; 95% CI for RR, 0.233-0.968). The indications for cesarean section were similar in both groups. Uterine rupture occurred in one patient in the sublingual group who was administered the third misoprostol dose in the active phase of labor.

Conclusions

No statistically significant differences were found in the vaginal delivery rates between sublingual and vaginal misoprostol, although adverse effects were more frequent with the sublingual route.     

Acceptability and feasibility of 400 μg buccal misoprostol after 200 mg mifepristone for early medical abortion in Georgia

Objectives: The aim of the study was to examine the acceptability and feasibility of early medical abortion using 200?mg mifepristone and 400?μg buccal misoprostol in Georgia, outside the capital city of Tbilisi.

Methods: A total of 622 women in four regions of western and eastern Georgia who presented for termination of pregnancy at up to 63?d of gestation were enrolled in the study. In the western regions, women took one 200?mg pill of mifepristone in the clinic and were given the option of administering 400?μg misoprostol buccally, either at the clinic or at home, 24–48?h later. In the eastern region, women were given the option to take both drugs at home. Abortion status was determined 2 weeks after mifepristone administration.

Results: Ninety-five percent of participants had a successful abortion. Twenty-one percent of women in the eastern region elected to take mifepristone at home; nearly all participants in both regions (98%) chose to take misoprostol at home. Ninety-five percent of women were very satisfied or satisfied with the method, and 95% said they would prefer medical abortion for a future procedure.

Conclusions: Medical abortion with mifepristone and 400?μg buccal misoprostol is an acceptable and feasible option for women in Georgia, outside the capital city of Tbilisi.     

Comparison between vaginal and sublingual misoprostol 50 µg for cervical ripening prior to induction of labor: randomized clinical trial

Objective

To compare the effectiveness and safety of sublingual versus vaginal misoprostol on improving the Bishop score after 6 h of administration.

Methods

Randomized clinical trial which includes pregnant women in gestational ages from 32/0 to 41/6, with indication of induction of labor with misoprostol. Bishop score was assessed at the time of induction and 6 h after administration of 50 µg misoprostol. Analysis was made over difference in mean Bishop score of 2 points, using a standard deviation of 2, with 90% power, reaching a 95% confidence interval.

Results

102 patients were studied, 51 received sublingual misoprostol, and 51 received vaginal misoprostol. There was a statistically significant difference in cervical modifications in global terms regardless of the administration route at 6 h (P?<?0.05). When analyzing each group, there was no significant difference for the mean and standard deviation for Bishop score for sublingual and vaginal route (P?=?0.761). There was no significant difference in terms of mode of delivery, Apgar score, cord pH, nor in the presence of complications.

Conclusion

There is no statistically significant difference in terms of administration route for cervical ripening using misoprostol 50 µg, whether it was sublingual or vaginal.

Trial registration number

NCT02732522.Registry website: https://clinicaltrials.gov/.

     

Randomized double-blind placebo controlled study of preinduction cervical priming with 25 µg of misoprostol in the outpatient setting to prevent formal induction of labour

Objective

To compare the efficacy of preinduction outpatient use of a single dose of 25 μg vaginal misoprostol between 38^1/2 and 40 weeks with that of placebo, to decrease the interval from intervention to delivery after stretch and sweep in low-risk gravid women with Bishop’s score <4.

Method

Sixty three women received 25 μg vaginal misoprostol and 63 women received placebo after stretch and sweep.

Results

The duration from intervention to delivery was 3.35 (1.12–9.46) days in the misoprostol group and 5.42 (2.39–10.11) days in the placebo group which was statistically significant (p = 0.029). Spontaneous labor was seen in 39 women (61.9 %) in the misoprostol group and 35 women (55.6 %) in the placebo group (p = 0.531). Eight women in the misoprostol group and 18 in the placebo group had Lower Segment Caesarean Section (LSCS) and this difference was also statistically significant (p = 0.027). There were no major maternal and neonatal complications in both groups.

Conclusion

Preinduction use of 25 μg vaginal misoprostol after stretch and sweep in the outpatient setting decreased the intervention to delivery interval when compared to placebo.

     

Neither vaginal nor buccal administration of 800 μg misoprostol alters mucosal and systemic immune activation or the cervicovaginal microbiome: a pilot study

Objectives: The aim of the study was to assess the extent to which misoprostol alters mucosal or systemic immune responses following either buccal or vaginal administration.

Methods: This was a prospective, crossover pilot study of 15 healthy, reproductive-age women. Women first received 800?μg misoprostol either via buccal or vaginal administration and were crossed over 1 month later to receive the drug via the other route. Cervicovaginal lavage samples, cervical Cytobrush samples, cervicovaginal swabs, urine and blood were obtained immediately prior to drug administration and the following day. Parameters assessed included urine and cervicovaginal misoprostol levels, whole blood cytokine responses (by ELISA) to immune stimulation with lipopolysaccharide, peripheral blood and cervical lymphocyte phenotyping by flow cytometry, cervicovaginal antimicrobial peptide measurement by ELISA and vaginal microbial ecology assessment by 16S rRNA sequencing.

Results: Neither buccal nor vaginal misoprostol significantly altered local or systemic immune and microbiological parameters.

Conclusion: In this pilot study, we did not observe significant alteration of mucosal or systemic immunology or vaginal microbial ecology 1?day after drug administration following either the buccal or vaginal route.     

Continuous Norethisterone Acetate versus Cyclical Drospirenone 3 mg/Ethinyl Estradiol 20 μg for the Management of Primary Dysmenorrhea in Young Adult Women

Study ObjectiveTo evaluate the efficacy of continuous norethisterone acetate (NET-A), 5 mg (group N) vs cyclical combined oral contraceptive pill (COC) consisting of drospirenone 3 mg/ethinyl estradiol 20 μg pills (group P) in treating dysmenorrhea in young adult women.Design, Setting, and ParticipantsThis prospective, open-label, nonrandomized study included 38 Jordanian patients: 20 patients in group N and 18 patients in group P.InterventionsContinuous NET-A 5 mg daily or cyclical COC.Main Outcome MeasuresPain scores, adverse effects, analgesic use, school absence, and cost.ResultsThirty-eight patients used NET-A or COC for 6 months. All participants had almost the same starting levels of visual analogue scale (VAS) scores. Both drugs were similar in suppressing dysmenorrhea at the 3-month follow-up visit; VAS score mean (±SD) in group N and P were 1.30 ± 1.22 and 1.28 ± 0.83 (P = .22), respectively, and after 6 months, with mean VAS scores (±SD) of 1.30 ± 1.22 and 1.28 ± 0.83, respectively (P = .95). The cost of the treatment in the N group was much less than in the P group. Participants in the N group were less likely to use pain killers: 20% and 44% in the N and P groups, respectively (P = .006) in the first month and only 5% and 17% (P = .019) in the N and P groups, respectively, at the 3-month follow-up, and none of them used any analgesics at the 6-month follow-up.ConclusionA continuous NET-A regimen is a well tolerated, effective, and inexpensive option for dysmenorrhea treatment and was as good as COC.     

Effect of α-tocopherol supplementation on <Emphasis Type="Italic">in vitro</Emphasis> maturation of sheep oocytes and <Emphasis Type="Italic">in vitro</Emphasis> development of preimplantation sheep embryos to the blastocyst stage

Purpose  

To determine the effects of α-tocopherol supplementation to oocyte maturation media and embryo culture media on the yield of ovine embryos.