Oral Misoprostol Tablets Research Articles

Evaluating misoprostol and mechanical methods for induction of labour: Scientific Impact Paper No. 68 April 2022.

Increasingly, births around the world are started artificially using medications or other methods. This process is known as induction of labour. As it becomes more common, methods are needed to meet the different clinical needs and birth preferences of women. Induction of labour typically includes a combination of the medication dinoprostone inserted into the vagina, artificial rupture of membranes ('releasing the waters'), and synthetic oxytocin (hormone given via a drip). This paper reviews some of the methods less commonly used for induction in the UK, namely a drug called misoprostol, which can be given orally or vaginally, and 'mechanical' methods, where labour is started by stretching the cervix (neck of the womb), most commonly with a soft silicone tube with a balloon near the tip, filled with water. Low-dose oral misoprostol tablets are now commercially available in the UK. Other methods for labour induction are not reviewed in detail in this paper. The evidence suggests mechanical induction of labour (using a balloon catheter) and misoprostol are both at least as safe and effective as using the standard drug, dinoprostone. There is evidence to suggest a balloon catheter may reduce the chance of serious negative outcomes for babies when compared with dinoprostone, and that giving low-dose oral misoprostol results in fewer caesarean births. Where possible and after informed consent, the method of induction of labour should be personalised to suit the individual woman, her clinical condition, and the setting in which she is giving birth. Local contexts and resources also need to be taken into account. To date, research into women's perspectives and experiences of induction of labour have been significantly lacking.

Induction of labour in nulliparous women- quick or slow: a cohort study comparing slow-release vaginal insert with low-dose misoprostol oral tablets

BackgroundThis study was undertaken with the objective of comparing efficacy and safety for two different regimens using misoprostol for induction of labour.MethodsThe study was set in two different hospitals in the region of Zeeland, Denmark, and designed as a prospective cohort study. Nulliparous women with unripe cervix, eligible for vaginal delivery and medical induction of labour were included. Exclusion criteria were a previous uterine scar, suspicion of growth restriction of the fetus and prelabour rupture of membranes.One department used 25 mcg oral misoprostol tablets and the other department used 200 mcg slow-release misoprostol vaginal insert, for induction of labour.Primary outcomes were predefined as frequency of cesarean section, tachysystole and delivery within 24 h. Secondary outcomes were: time from induction to delivery, use of additional methods for induction, postpartum hemorrhage, anal sphincter rupture, epidural, pyrexia (rectal temperature > 38.5 °C), prolonged rupture of membranes, and use of tocolysis.ResultsNo significant differences in women achieving vaginal delivery was found. However, a significantly increased risk of tachysystole for the vaginal administration route was observed; 28.4% compared with 2.3%. There were no events of serious neonatal asphyxia. Half of the women induced with vaginal insert delivered within 24 h, compared with 16.8% of the women induced with oral misoprostol.ConclusionsInduction with vaginal slow-release misoprostol leads to quicker delivery with an increased risk of tachysystole but with similar perinatal outcomes and rates of cesarean sections. Low-dose oral misoprostol appears to be safe, however it leads to an increased use of secondary methods and a tendency of more intrapartum pyrexia.Trial registrationClinicaltrials.gov ID: NCT02693587 on February 262,016.EudraCT number 2020–000366-42 on 23 January 2020, retrospectively registered.

428. Trials in low-resource settings: the INFORM study (oral misoprostol versus balloon induction in women with PIH or pre-eclampsia)

Between 62,000 and 77,000 women die annually from pre-eclampsia/eclampsia. Prompt delivery, preferably by the vaginal route, is vital for good maternal and neonatal outcomes. Two low cost interventions -low dose oral misoprostol tablets and transcervical Foley catheterisation- are already used in low resource settings. In this open label, parallel randomised study, our objective was to compare their relative risks and benefits. 602 women with a live fetus requiring delivery for pre-eclampsia or hypertension were randomly assigned to labour induction with oral misoprostol 25 micrograms every 2 h (maximum of 12 doses) or a transcervical Foley catheter (size 18 F with 30 ml balloon) which remained until active labour started, the Foley catheter fell out, or 12 h elapsed. Randomisation was computer-generated with allocation concealment by opaque sequentially numbered sealed envelopes. Induction continued with artificial membrane rupture and oxytocin, administered through a micro-drip gravity infusion set. Fetal monitoring was by intermittent auscultation. The primary outcome was vaginal birth within 24 h, and trial registration as with ClinicalTrials.gov (NCT01801410). 302 women were allocated to misoprostol and 300 women to Foley catheter; all were analysed. More women in the misoprostol arm had a vaginal birth within 24 h (57.0% vs. 47.0%; absolute risk difference (RD) 10.0%, with 95%CI 2.0% to 17.9%). Rates of uterine hyperstimulation were very low in both groups (0.7% vs 0.3%; RD 0.3%; −0.8% to 1.5%) and no differences were seen in neonatal morbidity. More women in the misoprostol group would use the same method in the future should they require another induction (82.8% vs. 72.0%; RD 10.8%; 4.2% to 17.4%). Oral misoprostol 25 micrograms was more effective and more acceptable to women than a transcervical Foley catheter for induction of labour in women requiring delivery because of pre-eclampsia or hypertension. MRC/DFID/Wellcome Trust Joint Global Health Trials Scheme (Ref. G1100686/1).

Misoprostol for termination of first trimester missed abortion.

Background: misoprostol is prostaglandin E1 analogue that can be given by oral, sublingual, vaginal or rectal route. It is cheap and can be stored at room temperature and because of its utero-tonic action, it become an important drug in obstetric and gynecological practice.Objectives: to evaluate the effectiveness of intravaginal followed by oral misoprostol tablets for medical termination of missed abortionbetween 8 – 13 weeks.
 Methods : a prospective study of (60) women with diagnosed missed abortion admitted to AL- Zahraa General hospital – Wassit Governorate Iraq from July 2006 through July 2007 . 800 micrograms (4 tablets) of misoprostol inserted in the posterior fornix of the vagina after moisture with normal saline followed by oral 400 micrograms (2 tablets) 6 hours later. Another 400 micrograms were given orally 6 hours from the last dose for those patients whodid not respond to theprevious two doses.Results: (48) patients (80%) had complete expulsion . (21) Patients (35%) after the vaginal dose. (15) Patients (25%) respond after the first oral dose and (12) patients (20%) after the second oral dose. (6) Patients (10%) had incomplete abortion; the remainder (6) patients (10%) failed to respond within 24 hours of starting treatment and require surgical evacuation. The mean time for expulsion was 10 hours.Conclusion: first trimester missed abortion medical termination by misoprostol is effective, save and a practical Methods .

Foley catheterisation versus oral misoprostol for induction of labour in hypertensive women in India (INFORM): a multicentre, open-label, randomised controlled trial

Between 62 000 and 77 000 women die annually from pre-eclampsia and eclampsia. Prompt delivery, preferably by the vaginal route, is vital for good maternal and neonatal outcomes. Two low-cost interventions-low-dose oral misoprostol tablets and transcervical Foley catheterisation-are already used in low-resource settings. We aimed to compare the relative risks and benefits of these interventions. We undertook this multicentre, open-label, randomised controlled trial in two public hospitals in Nagpur, India. Women (aged ≥18 years) who were at 20 weeks' gestation or later with a live fetus and required delivery as a result of pre-eclampsia or hypertension were randomly assigned (1:1), via computer-generated block randomisation (block sizes of four, six, and eight) with concealment by use of opaque, sequentially numbered, sealed envelopes, to receive labour induction with either oral misoprostol 25 μg every 2 h (maximum of 12 doses) or a transcervical Foley catheter (silicone, size 18 F with 30 mL balloon). Randomisation was stratified by study centre. The catheter remained in place until active labour started, the catheter fell out, or 12 h had elapsed. If the catheter did not fall out within 12 h, induction continued with artificial membrane rupture and oxytocin, administered through a micro-drip gravity infusion set. Fetal monitoring was by intermittent auscultation. The primary outcome was vaginal birth within 24 h. Due to the nature of the interventions, masking of participants, study investigators, and care providers to group allocation was not possible. We analysed by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01801410. Between Dec 20, 2013, and June 29, 2015, we randomly assigned 602 women to induction with misoprostol (n=302) or the Foley catheter (n=300; intention-to-treat population). Vaginal birth within 24 h was more common in women in the misoprostol group than in the Foley catheter group (172 [57·0%] vs 141 [47·0%] women; absolute risk difference 10·0%, 95% CI 2·0-17·9; p=0·0136). Rates of uterine hyperstimulation were low in both the misoprostol and Foley catheter groups (two [0·7%] vs one [0·3%] cases; absolute risk difference 0·3%, 95% CI -0·8 to 1·5; p=0·566) and neonatal deaths did not differ significantly between groups (six [2·0%] vs three [1·0%] neonatal deaths; 1·0, -1·04 to 2·97; p=0·322). 17 serious adverse events (3%) were reported during the study: one case of intrapartum convulsion and one case of disseminated intravascular coagulation (both in the Foley group); ten perinatal deaths, including two stillbirths (both in the Foley catheter group) and eight neonatal deaths (n=5 in the misoprostol group and n=3 in the Foley catheter group); and five of neonatal morbidity, comprising birth asphyxia (n=3), septicaemia (n=1), and neonatal convulsion (n=1). Oral misoprostol was more effective than transcervical Foley catheterisation for induction of labour in women with pre-eclampsia or hypertension. Future studies are required to assess whether oxytocin augmentation following misoprostol can be replaced by regular doses of oral misoprostol tablets. Medical Research Council, Department for International Development, and Wellcome Trust Joint Global Health Trials Scheme.

Oral versus rectal misoprostol in the treatment of menorrhagia

Abstract Introduction Excessive menstrual loss is a major problem. Effective medical treatments exist and may provide an alternative to surgery. Objective Evaluation of the effects of oral and rectal misoprostol in the treatment of excessive blood loss in cases of menorrhagia and comparison between both routes. Subjects and methods Sixty patients with heavy, but however, regular periods (menorrhagia) were included in the study. They were randomly divided into two equal groups. Both groups were evaluated in two consecutive menstrual cycles. First without the treatment (baseline value) and the second cycle by either rectal misoprostol tablets (three times daily for the first 3days of the bleeding) or by oral misoprostol tablets (one tablet three times daily for the first 3days of the bleeding). For both the groups the estimated menstrual blood loss was assessed before and after treatment using subjective and objective assessments. Results A highly statistical significant reduction in menstrual blood loss occurred by treatments in both groups ( p =0.000). Rectal misoprostol produced the highest reduction in the menstrual blood loss with a percent change of 53.45%, while oral misoprostol was less effective in reducing the menstrual blood loss with a percent change of 36.15%. Both routes were effective in improving dysmenorrhea and reducing the number of cycle days with no significant differences between them. Conclusions Both rectal and oral misoprostol are safe and effective routes for reducing excessive menstrual blood loss (menorrhagia), but the rectal route is more effective.

Postpartum intrauterine pressure studies of the uterotonic effect of oral misoprostol and intramuscular syntometrine

Objectives To investigate the effect of oral misoprostol in dosages varying from 200 μg to 800 μg on postpartum uterine contractility and to establish their side effects. Design A prospective descriptive study. Participants Fifty-seven women who delivered vaginally after spontaneous labours not requiring augmentation. Methods Within 5 minutes of delivery of the placenta, a calibrated Gaeltec catheter with an intrauterine pressure transducer at its tip was inserted transcervically into the uterine cavity. Cumulative uterine activity was recorded for 30 minutes in each woman before administering the oral misoprostol tablets and continued for a further 90 minutes after its administration. Thus each woman acted as her own control regarding changes in uterine contractility. Uterine activity was recorded on a Sonicaid Meridian fetal monitor, which measures active contraction area automatically. The incidence of side effects was also recorded. Results There was no statistical difference ( P=0.887) in the adjusted mean difference in cumulative uterine activity following all the doses of oral misoprostol, compared with intramuscular syntometrine, the largest difference being seen in oral misoprostol 200 μg (adjusted mean difference –2282 kPas s, 95% CI –7954 to 3390 kPas s). The mean onset of action of oral misoprostol (6.1, SD 2.1 min) was significantly slower than that of intramuscular syntometrine (3.2, SD 1.5 min; P=0.002), but their durations of action were similar ( P=0.637). In the misoprostol group the commonest side effects were shivering (36%) and a rise in body temperature above 38°C (40%). In the syntometrine group, the most commonly observed side effect was moderate uterine pain (nine out of ten women) and a rise in diastolic blood pressure of 20 mmHg (two out of ten women). Conclusion The results of this study show that oral misoprostol has a definite uterotonic effect on the postpartum uterus. At doses of 200 μg to 400 μg, oral misoprostol has a similar uterotonic effect to intramuscular syntometrine. Higher doses of oral misoprostol are associated with significantly more side effects.

Postpartum intrauterine pressure studies of the uterotonic effect of oral misoprostol and intramuscular syntometrine.

To investigate the effect of oral misoprostol in dosages varying from 200 microg to 800 microg on postpartum uterine contractility and to establish their side effects. A prospective descriptive study. Fifty-seven women who delivered vaginally after spontaneous labours not requiring augmentation. Within 5 minutes of delivery of the placenta, a calibrated Gaeltec catheter with an intrauterine pressure transducer at its tip was inserted transcervically into the uterine cavity. Cumulative uterine activity was recorded for 30 minutes in each woman before administering the oral misoprostol tablets and continued for a further 90 minutes after its administration. Thus each woman acted as her own control regarding changes in uterine contractility. Uterine activity was recorded on a Sonicaid Meridian fetal monitor, which measures active contraction area automatically. The incidence of side effects was also recorded. There was no statistical difference (P = 0.887) in the adjusted mean difference in cumulative uterine activity following all the doses of oral misoprostol, compared with intramuscular syntometrine, the largest difference being seen in oral misoprostol 200 microg (adjusted mean difference -2282 kPas s, 95% CI -7954 to 3390 kPas s). The mean onset of action of oral misoprostol (6.1, SD 2.1 min) was significantly slower than that of intramuscular syntometrine (3.2, SD 1.5 min; P = 0.002), but their durations of action were similar (P = 0.637). In the misoprostol group the commonest side effects were shivering (36%) and a rise in body temperature above 38 degrees C (40%). In the syntometrine group, the most commonly observed side effect was moderate uterine pain (nine out of ten women) and a rise in diastolic blood pressure of 20 mmHg (two out of ten women). The results of this study show that oral misoprostol has a definite uterotonic effect on the postpartum uterus. At doses of 200 microg to 400 microg, oral misoprostol has a similar uterotonic effect to intramuscular syntometrine. Higher doses of oral misoprostol are associated with significantly more side effects.