Low-dose oral misoprostol for induction of labour

Kerr, Robert S.; Kumar, Nimisha; Williams, Myfanwy J; Cuthbert, Anna; Aflaifel, Nasreen; Haas, David M.; Weeks, Andrew

doi:10.1002/14651858.cd014484

Cited by 43 publications

(71 citation statements)

References 110 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Although all standard methods were effective, high‐dose vaginal misoprostol (50 micrograms or more), dinoprostone and low‐dose oral misoprostol solution (less than 50 micrograms) achieved the most vaginal births within 24 hours. Comparing the prostaglandins, low‐dose oral misoprostol solution is associated with lower rates of caesarean birth, for both fetal heart rate abnormalities and progress in labour 10,11 . All methods were generally safe, but the main complication of uterine hyperstimulation was highest with high‐dose vaginal misoprostol, and lowest in women induced with double‐balloon catheter (two fluid‐filled balloons either side of the cervix).…”

Section: Misoprostolmentioning

confidence: 99%

Evaluating misoprostol and mechanical methods for induction of labour

Weeks¹,

Lightly²,

Mol³

et al. 2022

BJOG

View full text Add to dashboard Cite

Plain language summaryIncreasingly, 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.

show abstract

Section: Misoprostolmentioning

confidence: 99%

Evaluating misoprostol and mechanical methods for induction of labour

Weeks¹,

Lightly²,

Mol³

et al. 2022

BJOG

View full text Add to dashboard Cite

show abstract

“…Healthy Chinese subjects (n = 48) were enrolled under fasting conditions. Since the intra‐subject coefficient of variation (CV, ∼32.5%) was higher than the AUC 0‐t , the MPA's C max was used to calculate the sample size 10 . Forty‐eight subjects provided at least 80% power to have a 90% confidence interval (CI) of the estimated geometric least square mean (GLSM) ratio within the bioequivalence acceptance criteria of 80%–125%, assuming intrasubject variability CV of 32.5% and considering a potential 10% dropout rate.…”

Section: Methodsmentioning

confidence: 99%

“…Additionally, it can be used to induce labor following intrauterine fetal demise. [8][9][10] Meanwhile, misoprostol can be used to treat postpartum uterine bleeding. [11][12][13] Misoprostol is a pro-drug without active effect, being rapidly converted by de-esterification to misoprostol acid (MPA, the preliminary active metabolite), therefore unchanged misoprostol cannot be detected in the plasma even at 5 minutes after oral administration.…”

mentioning

confidence: 99%

See 1 more Smart Citation

Pharmacokinetics and Bioequivalence of Misoprostol Tablets: An Open‐Label, Randomized, Single‐dose, Crossover Study With Healthy Chinese Volunteers

Wang

Han

et al. 2022

Clinical Pharm in Drug Dev

View full text Add to dashboard Cite

Misoprostol is a synthetic prostaglandin E1 derivative that has been used to treat duodenal and gastric ulcers, and to prevent ulcers caused by nonsteroidal anti‐inflammatory drugs in many countries. Misoprostol can also be used for medical abortion. This study aimed to investigate the pharmacokinetic profiles of misoprostol tablets (test product) by comparing them with Cytotec (200 μg) (reference product). To assess the bioequivalence between test and reference products, a two‐sequence, two‐period crossover study was conducted with 48 healthy Chinese subjects enrolled under fasting conditions. A validated liquid chromatography‐tandem mass spectrometry (LC‐MS/MS) assay was used to determine the concentration of misoprostol acid in plasma. A mixed model analysis of variance was used to calculate the bioequivalence of pharmacokinetic (PK) parameters. The point estimate of geometric mean ratios with 90% confidence intervals for the maximum observed concentration (Cmax) and the area under the concentration‐time curve (AUC0‐t) for misoprostol acid in reference and test products were 107.8% and 106.5%, respectively (range 80%–125%). Additionally, none of the secondary PK parameters presented significant differences. No severe or more than moderate adverse events were detected in the 48 subjects. However, one subject discontinued the treatment due to drug‐related gastrointestinal reactions. All adverse events were mild with rates of 19.2% and 22.9% after the administration test and reference products, respectively. Overall, the bioequivalence between the two misoprostol products was demonstrated in fasting conditions, and all subjects tolerated both treatments.

show abstract

“…Induction of labour with low dose oral misoprostol results in fewer caesarean sections than standard induction methods, found a Cochrane review of 61 trials involving 20 026 women 2. Misoprostol was also associated with lower rates of hyperstimulation with fetal heart rate changes.…”

Section: Obstetricsmentioning

confidence: 98%

Seven days in medicine: 23-29 June 2021

2021

BMJ

View full text Add to dashboard Cite

Low-dose oral misoprostol for induction of labour

Cited by 43 publications

References 110 publications

Evaluating misoprostol and mechanical methods for induction of labour

Evaluating misoprostol and mechanical methods for induction of labour

Pharmacokinetics and Bioequivalence of Misoprostol Tablets: An Open‐Label, Randomized, Single‐dose, Crossover Study With Healthy Chinese Volunteers

Seven days in medicine: 23-29 June 2021

Contact Info

Product

Resources

About