Off-label use of misoprostol for labor induction in Germany: a national survey

Voigt, F; Goecke, Tamme W.; Najjari, Laila; Pecks, Ulrich; Maass, Nicolaì; Rath, Werner

doi:10.1016/j.ejogrb.2014.11.026

Cited by 36 publications

(41 citation statements)

References 24 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Prior to the marketing authorization for MVI in Germany, the majority (two-thirds) of obstetricians who responded in a national survey stated that they used off-label misoprostol for labor induction for viable term pregnancies [13]. As such, despite concerns about potential legal consequences, many German obstetricians were familiar with the effectiveness and established clinical practice of labor induction with misoprostol tablet fragments [14].…”

Section: Introductionmentioning

confidence: 99%

Clinical experience with misoprostol vaginal insert for induction of labor: a prospective clinical observational study

Neophytou

Hars²,

Freudenberg

et al. 2018

Arch Gynecol Obstet

View full text Add to dashboard Cite

PurposeTo provide real-world evidence using misoprostol vaginal insert (MVI) for induction of labor in nulliparous and parous women at two German Level I Centers in a prospective observational study.MethodsBetween 1 August 2014 and 1 October 2015, eligible pregnant women (≥ 36 + 0 weeks of gestation) requiring labor induction were treated with MVI. Endpoints included time to and mode of delivery rates of tocolysis use, tachysystole, uterine hypertonus or uterine hyperstimulation syndrome and newborn outcomes.ResultsOf the 354 women enrolled, 68.9% (244/354) achieved vaginal delivery (nulliparous, 139/232 [59.9%]; parous 105/122 [86.1%]; p < 0.001). Median time from MVI administration to vaginal delivery was 14.0 h (nulliparous, 14.5 h; parous, 11.9 h; p < 0.001). A total of 205/244 (84.0%) and 228/244 (93.4%) women achieved a vaginal delivery within 24 h and 30 h, respectively. The most common indications for cesarean delivery were pathologic cardiotocography (nulliparous, 41/232 [17.4%]; parous, 13/122 [10.7%]; p = 0.081) and arrested labor (dilation or descent; nulliparous, 45/232 [19.4%], parous, 3/122 [2.5%]; p ≤ 0.001). A total of 24.3% of women experienced uterine tachysystole and 9.6% experienced uterine tachysystole with fetal heart rate involvement, neither of which were significantly different for nulliparous and parous women. In total, 42/345 (12.2%) of the neonates had an arterial pH < 7.15 and 12/345 3.5% had a 5-min Apgar score ≤ 7.ConclusionWhen clinically indicated, MVI was efficient and safe for induction of labor in women with an unfavorable cervix. Women, however, should be counseled regarding the risk of uterine tachysystole prior to labor induction with MVI.

show abstract

Section: Introductionmentioning

confidence: 99%

Clinical experience with misoprostol vaginal insert for induction of labor: a prospective clinical observational study

Neophytou

Hars²,

Freudenberg

et al. 2018

Arch Gynecol Obstet

View full text Add to dashboard Cite

show abstract

“…Although misoprostol is not approved for labor induction, its low cost, stability at room temperature, multiple administration routes, and greater acceptability among pregnant women with oral administration contributed to its widespread off-label use in Europe and most other countries [8]. Many randomized controlled trials have searched for the optimum induction of labor regimen for successful vaginal delivery with fewer adverse effects.…”

Section: Discussionmentioning

confidence: 99%

Oral Misoprostol 2 Hourly for Labor Induction

Kafy¹

2018

OJOG

View full text Add to dashboard Cite

The objective of this study was to assess the efficacy and safety of the 2 hourly oral misoprostol for labor induction. Between May and November 2013, the hospital records of 83 women who were induced for labor and met the eligibility criteria were retrospectively reviewed. Eligibility criteria were singleton pregnancy of at least 34 weeks' gestation and a baseline Bishop score < 6. Women with a previous cesarean section or other uterine surgery, severe pregnancy-induced hypertension, and parity of 4 or more were excluded. Oral misoprostol was administered as 20 µg 2 hourly unless active labor. A maximum of 12 doses was allowed. The age of the women was 27.9 ± 5.3 years (mean ± SD). Vaginal delivery within 24 hours occurred in 38 (45.8%) women. Cesarean delivery occurred in 17 (20.5%) women. Although more parous women achieved vaginal delivery within 24 hours (52.6%) compared with nulliparous women (40.0%), the difference was not significant (P = .35). Uterine tachysystole occurred in 12 (14.5%) women. No perinatal deaths or neonatal intensive care unit admission occurred in the study group. Evidence supporting an optimal regimen is lacking, and additional research is warranted to optimize the use of oral misoprostol for the induction of labor.

show abstract

“…Abdul Rahim also in a clinical trial study showed cost effectiveness of oral misoprostol to induce labour [24]. Voigt et al, in a study have explained that the most common reasons given for using misoprostol in labour induction were: effectiveness, good patient acceptance, established/well proven in clinical practice, and cost-effectiveness [25]. A clinical trial by Faucett et al, reported that oral misoprostol administered during labour induction in nulliparous women resulted in shorter time to vaginal delivery without adverse outcomes [26].…”

Section: Discussionmentioning

confidence: 99%