An audit of oral administration of Angusta® (misoprostol) 25 µg for induction of labor in 976 consecutive women with a singleton pregnancy in a university hospital in Denmark

Abstract

Introduction Induction of labor (IOL) is used to improve the outcome of pregnancy for mother and child. Since 2013, oral misoprostol has been used for IOL at Aarhus University Hospital, Denmark. The purpose of the present paper is to describe our experience of the use of a new, 25‐µg misoprostol tablet commercially manufactured for the purpose of IOL regarding efficacy and outcome for mother and neonate in both an inpatient and an outpatient regimen. Material and methods We performed an audit from 1 April 2016, including data on all IOL in women with singleton pregnancies until 1000 consecutive women were registered. Data from 976 consecutive women with gestational age ≥37+0 weeks induced in accordance with the “Aarhus protocol” were included in the present analyses. All inductions were by oral misoprostol. Outpatient induction is standard procedure in low‐risk pregnancies, that is, pregnancies with a healthy mother and no signs of placental insufficiency. In the outpatient IOL, the first dose of misoprostol is administered after a normal cardiotocography registration at the hospital. Subsequent doses are taken at home according to a predefined regimen. Following delivery, data on baseline variables and outcome variables for the mother and neonate were retrieved from the medical records. Results In 71.9% of cases, the women were induced in an outpatient regimen. Delivery within 24 hours was achieved in 38.8% of women (nulliparous 32.3%, multiparous 50.9%) and within 48 hours in 70.1% (nulliparous 66.2%, multiparous 77.2%). Hyperstimulation during induction occurred in 0.6%. The mode of delivery was spontaneous vaginal in 75.5% of cases. The cesarean section rate was 14.9% (nulliparous 20.7%, multiparous 4.1%). Apgar <7 at 5 minutes and pH <7.0 in the umbilical artery was seen in 0.9% and 0.7%, respectively. Conclusions Induction of labor by a commercially produced low‐dose (25 µg) misoprostol tablet for oral induction according to the “Aarhus protocol” is feasible in an outpatient as well as an inpatient regimen. Delivery was achieved within 48 hours for 70.1% of women. Few adverse events were seen; however, the audit was underpowered for safety.

Labour Induction with Misoprostol in German Obstetric Clinics: What Are the Facts on Such Use?

“…Induction of labour with misoprostol was almost always done in an inpatient setting (97%). Despite this being practised in outpatient settings as well internationally 29 this is discouraged in current recommendations. Medical labour induction should be performed in an inpatient setting under CTG control 13 , 15 , 16 .…”

“…Die Geburtseinleitung mit Misoprostol erfolgte fast immer stationär (97 %). Auch wenn es international im ambulanten Setting durchgeführt wird [29], wird hiervon in aktuellen Empfehlungen abgeraten. Eine medikamentöse Geburtseinleitung soll unter CTG-Kontrolle stationär erfolgen [13,15,16].…”

Childbirth care in a regional healthcare network of the Mãe Paranaense Network

“…A administração de misoprostol, utilizado para indução do parto, pode ser associada ao maior número de parto cesárea (10) . A justificativa se refere ao fato de a gestação alcançar as 40 semanas, mas não iniciar o trabalho de parto, nestes casos, a utilização deste medicamento é recomendada para induzir modificações na cérvice uterina, seguida pela ação de contração, contudo, pode ocorrer falhas de indução, levando a necessidade de realizar o parto cesárea, pelo avançar da idade gestacional (10) . Esta relação do uso do misoprostol com o parto cesárea não foi evidenciada nesta pesquisa.…”

“…Quanto ao uso de ocitocina, a proporção de respostas positivas ao uso durante o parto é maior nos casos de parto vaginal. Também, é comumente utilizada para acelerar o trabalho de parto, no entanto, a perfusão de ocitocina para estimulação do parto é significativamente associada ao aumento das taxas de cesáreas, além de maior percentual de febre materna intraparto (10)(11) . Apesar dos riscos associados ao uso da ocitocina, a utilização desta é bastante presente em hospitais, podendo estar relacionada à cultura assistencial hospitalar (12) .…”

Italian Society of Gynaecology and Obstetrics (SIGO): Consensus paper on induction of labor with oral administration of Misoprostol

“…Based on data from Scandinavian studies (24), it is reasonable to propose the administration of one 25 mcg tablet per os every 2 hours, for a total of 6 doses on the first day of induction. In case of failure, this procedure can be repeated on day two, with a maximum of 8 doses.…”