Misoprostol as Oral Solution or Oral Tablet for Induction of Labour (MISOBEST): A Randomised Controlled Non-Inferiority Trial.

ABSTRACT:

Objective

To assess if off-label oral solution of misoprostol compared with licensed oral tablet of misoprostol approved for induction of labour (IOL) is as efficient in resulting in vaginal delivery within 24 h, using a non-inferiority design.

Design

Prospective, randomised, non-inferiority, open-label, blinded endpoint trial.

Setting

Two tertiary level hospitals, Stockholm, Sweden, January 2022 to May 2023.

Population

In all, 874 women, without previous caesarean section, with an unripe cervix and a singleton, cephalic foetus at 37 + 0 to 42 + 0 gestational weeks, with a normal cardiotocography, planned for IOL were included.

Methods

Women were randomised 1:1 to intervention (25 μg oral solution of misoprostol) or control (25 μg oral tablet of misopros

SUBMITTER: Svensk E 

PROVIDER: S-EPMC11704078 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature