A randomised open-label trial to assess outpatient induction of labour (HOMEIND) and compare efficacy of Propess vs Dilapan-S® for induction of labour at 39 weeks’ gestation in normal risk nulliparous women: study protocol for a randomised controlled trial

Trials

Study Protocol

Orla Smith¹  Zara Molphy²  Patrick Dicker²  Susan Hatt²  Sarah M. Nicholson³  Karen Flood³  Fergal Malone³ 

[1] Rotunda Hospital, Dublin, Ireland;Royal College of Surgeons in Ireland, Dublin, Ireland;Royal College of Surgeons in Ireland, Dublin, Ireland;Rotunda Hospital, Dublin, Ireland;

关键词: Induction of labour;    Outpatient induction;    Dilapan-S;    Propess;    Induction;    Elective induction of labour;    Cervical priming;    Osmotic dilator;    Cervical ripening;   

DOI  :  10.1186/s13063-023-07174-7

 received in 2023-01-30, accepted in 2023-02-15,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundInduction of labour (IOL) at 39 weeks has been shown to decrease maternal and neonatal adverse outcomes. Given the growing demand for 39-week IOL, it is imperative that effective methods be assessed for induction in the outpatient setting.The aim of this study is to answer the clinical question as to whether Dilapan-S® vs Propess® as a method of cervical ripening is non-inferior in the outpatient setting at 39 weeks and to ascertain whether Dilapan-S® 12 h is non-inferior to Dilapan-S® 24 h.MethodsThis study is an open-label parallel group single-centre randomised trial.Participants are normal risk nulliparous women who have no pregnancy-related or medical contraindication to IOL. Women will be randomised to one of three induction groups—Dilapan-S® (12-h insertion or 24-h insertion) or Propess. Induction will be initiated between 39+0 and 39+4 weeks’ gestation and participants will return home for either 12 or 24 h. They will be readmitted 12/24 h later in order to continue with induction of labour.Patient recruitment will take place over 30 months within a single centre. The study will recruit a maximum 109 women for each study arm. Total duration of participants’ involvement in the trial will be 8 weeks to allow for postpartum follow-up.DiscussionThis study will definitively answer whether Dilapan-S is non-inferior to Propess® as a method of induction of labour in the outpatient setting and whether cervical ripening with Dilapan-S over a 12-h timeframe is non-inferior to cervical ripening with Dilapan-S over a 24-h timeframe.Trial registrationEudraCT Number 2019-004697-25 Registered 14 September 2020

【 授权许可】

CC BY   
© The Author(s) 2023