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
Abstract Background Induction 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 c...
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| Format: | Article |
| Language: | English |
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BMC
2023-02-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-023-07174-7 |
| _version_ | 1797863605123678208 |
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| author | Sarah M. Nicholson Orla Smith Susan Hatt Zara Molphy Patrick Dicker Karen Flood Fergal Malone |
| author_facet | Sarah M. Nicholson Orla Smith Susan Hatt Zara Molphy Patrick Dicker Karen Flood Fergal Malone |
| author_sort | Sarah M. Nicholson |
| collection | DOAJ |
| description | Abstract Background Induction 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. Methods This 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. Discussion This 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 registration EudraCT Number 2019-004697-25 Registered 14 September 2020 |
| first_indexed | 2024-04-09T22:39:17Z |
| format | Article |
| id | doaj.art-5a5cff01da8d457fb7435ac569715f61 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-09T22:39:17Z |
| publishDate | 2023-02-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-5a5cff01da8d457fb7435ac569715f612023-03-22T12:18:25ZengBMCTrials1745-62152023-02-0124111210.1186/s13063-023-07174-7A 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 trialSarah M. Nicholson0Orla Smith1Susan Hatt2Zara Molphy3Patrick Dicker4Karen Flood5Fergal Malone6Royal College of Surgeons in IrelandRotunda HospitalRoyal College of Surgeons in IrelandRoyal College of Surgeons in IrelandRoyal College of Surgeons in IrelandRoyal College of Surgeons in IrelandRoyal College of Surgeons in IrelandAbstract Background Induction 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. Methods This 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. Discussion This 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 registration EudraCT Number 2019-004697-25 Registered 14 September 2020https://doi.org/10.1186/s13063-023-07174-7Induction of labourOutpatient inductionDilapan-SPropessInductionElective induction of labour |
| spellingShingle | Sarah M. Nicholson Orla Smith Susan Hatt Zara Molphy Patrick Dicker Karen Flood Fergal Malone 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 Induction of labour Outpatient induction Dilapan-S Propess Induction Elective induction of labour |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | randomised open label trial to assess outpatient induction of labour homeind and compare efficacy of propess vs dilapan s r for induction of labour at 39 weeks gestation in normal risk nulliparous women study protocol for a randomised controlled trial |
| topic | Induction of labour Outpatient induction Dilapan-S Propess Induction Elective induction of labour |
| url | https://doi.org/10.1186/s13063-023-07174-7 |
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