Labour induction in low-risk women at 39 weeks of gestation: a randomised trial in China (LIRIC) - protocol of an open label, randomised controlled trial.
Source: PubMed, NCBI / U.S. National Library of Medicine
The A Randomized Trial of Induction Versus Expectant Management (ARRIVE) first demonstrated that elective induction of labour (IOL) at 39 weeks in low-risk pregnancies reduced the likelihood of caesarean section (CS) without compromising perinatal safety; however, the generalisability of these findings remains debated, leading to uncertainty in clinical practice. The Labour Induction in Low-risk Women at 39 Weeks of Gestation: a Randomised Trial in China (LIRIC) aims to evaluate whether 39-week elective IOL reduces CS rates compared with expectant management while exploring its impact on infant neurodevelopment and multiomics profiles. This is a single-centre, open-label, randomised controlled trial in China. A total of 1074 low-risk pregnant women (nulliparous or multiparous) will be randomly assigned (1:1 ratio) to either 39-week IOL or expectant management. The primary outcome is the CS rate. Secondary outcomes include a composite of severe neonatal morbidity and perinatal mortality and infant neurodevelopmental scores (Bayley Scales of Infant Development; Bayley-4 and Ages and Stages Questionnaires; ASQ-3), among others. Data analysis will follow the intention-to-treat principle. Biospecimen will be collected for metagenomic and metabolomic analyses, with results to be reported separately. The protocol has been approved by the Ethics Committee of Women's Hospital, School of Medicine, Zhejiang University. Informed consent will be obtained from all participants. Results wil
Abstract
The A Randomized Trial of Induction Versus Expectant Management (ARRIVE) first demonstrated that elective induction of labour (IOL) at 39 weeks in low-risk pregnancies reduced the likelihood of caesarean section (CS) without compromising perinatal safety; however, the generalisability of these findings remains debated, leading to uncertainty in clinical practice. The Labour Induction in Low-risk Women at 39 Weeks of Gestation: a Randomised Trial in China (LIRIC) aims to evaluate whether 39-week elective IOL reduces CS rates compared with expectant management while exploring its impact on infant neurodevelopment and multiomics profiles. This is a single-centre, open-label, randomised controlled trial in China. A total of 1074 low-risk pregnant women (nulliparous or multiparous) will be randomly assigned (1:1 ratio) to either 39-week IOL or expectant management. The primary outcome is the CS rate. Secondary outcomes include a composite of severe neonatal morbidity and perinatal mortality and infant neurodevelopmental scores (Bayley Scales of Infant Development; Bayley-4 and Ages and Stages Questionnaires; ASQ-3), among others. Data analysis will follow the intention-to-treat principle. Biospecimen will be collected for metagenomic and metabolomic analyses, with results to be reported separately. The protocol has been approved by the Ethics Committee of Women's Hospital, School of Medicine, Zhejiang University. Informed consent will be obtained from all participants. Results will be disseminated via peer-reviewed journals, and standardised infant developmental reports will be provided to participants to enhance study benefit. NCT07082530.