Slow-release vaginal insert of misoprostol versus orally administrated solution of misoprostol for the induction of labour in primiparous term pregnant women: a randomised controlled trial.

Autor: Wallström T; Department of Clinical Science and Education, Department of Obstetrics and Gynaecology, Karolinska Institute, Sodersjukhuset, Stockholm, Sweden., Strandberg M; Department of Clinical Science and Education, Department of Obstetrics and Gynaecology, Karolinska Institute, Sodersjukhuset, Stockholm, Sweden., Gemzell-Danielsson K; Department of Women's and Children's Health, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden., Pilo C; Department of Clinical Science and Education, Department of Obstetrics and Gynaecology, Karolinska Institute, Sodersjukhuset, Stockholm, Sweden., Jarnbert-Pettersson H; Department of Clinical Science and Education, Department of Obstetrics and Gynaecology, Karolinska Institute, Sodersjukhuset, Stockholm, Sweden., Friman-Mathiasson M; Department of Obstetrics and Gynaecology, Kristianstad, Sweden., Wiberg-Itzel E; Department of Clinical Science and Education, Department of Obstetrics and Gynaecology, Karolinska Institute, Sodersjukhuset, Stockholm, Sweden.
Jazyk: angličtina
Zdroj: BJOG : an international journal of obstetrics and gynaecology [BJOG] 2019 Aug; Vol. 126 (9), pp. 1148-1155. Date of Electronic Publication: 2019 May 15.
DOI: 10.1111/1471-0528.15796
Abstrakt: Objective: To compare the World Health Organization (WHO) recommended orally administrated dosage of misoprostol (25 μg) with a vaginal slow-release (7 μg/hour) insert of misoprostol regarding time from induction to delivery and safety of the method.
Design: Open label, Randomised controlled trial (RCT).
Setting: Delivery ward at a secondary referral hospital in Stockholm, Sweden, from 1 October 2016 to 21 February 2018.
Population: One hundred and ninety-six primiparous women with singletons in cephalic presentation at ≥37 weeks of gestation and with a Bishop score of ≤4.
Methods: Women were randomised to an oral solution of misoprostol (Cytotec ® n = 99) or vaginal slow-release misoprostol (Misodel ® [MVI] n = 97).
Main Outcome Measures: Primary outcome: time from induction to vaginal delivery.
Secondary Outcomes: mode of delivery; proportion of vaginal deliveries within 24 hours (VD24); neonates with an Apgar score of <7 at 5 minutes; pH < 7.10; postpartum haemorrhage (PPH) of >1000 ml; hyperstimulation; and women's delivery experience (VAS).
Results: There was no difference in the time to delivery [corrected] (median 21.1 hours in the MVI group and 23.2 hours in the oral group; Kaplan-Mayer log rank P = 0.31). There was no difference regarding the proportion of VD24 (50.5 versus 55.7%, P = 0.16). Hyperstimulation with non-reassuring cardiotocography (CTG) was more common in the MVI group (14.4 versus 3.0%, P < 0.01). Terbutaline (Bricanyl ® ) was used more often for hyperstimulation in the MVI group (22.7 versus 4.0%, P < 0.01). There was no difference in the numbers of children admitted to the neonatal intensive care unit (NICU).
Conclusions: Vaginal delivery after induction of labour (IOL) with slow-release misoprostol did not result in a shorter time from induction to vaginal delivery, compared with oral misoprostol solution, but was associated with a higher risk for hyperstimulation and fetal distress. There were no differences in mode of delivery or neonatal outcome.
Tweetable Abstract: IOL with MVI was similar to oral solution of misoprostol but hyperstimulation and fetal distress were more common.
(© 2019 Royal College of Obstetricians and Gynaecologists.)
Databáze: MEDLINE
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