Induction of labour for predicted macrosomia: study protocol for the ‘Big Baby’ randomised controlled trial
Introduction Large-for-gestational age (LGA) fetuses have an increased risk of shoulder dystocia. This can lead to adverse neonatal outcomes and death. Early induction of labour in women with a fetus suspected to be macrosomic may mitigate the risk of shoulder dystocia. The Big Baby Trial aims to fi...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2022-11-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/11/e058176.full |
| _version_ | 1797988719618162688 |
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| author | Martin Underwood Sara Wood Stavros Petrou Jaclyn Brown Simon Gates Ceri Jones Mandy Williams Hema Mistry Anne-Marie Slowther Katie Booth Ranjit Lall Debra Bick Siobhan Quenby SANJEEV DESHPANDE Joanne D Fisher Jason Gardosi Adam Gornall Adrian Willis Lauren Jade Ewington Ryan Griffin Kirsten Harris Emily Butler Kelly Fowler Jackie Dewdney Karen Hillyer |
| author_facet | Martin Underwood Sara Wood Stavros Petrou Jaclyn Brown Simon Gates Ceri Jones Mandy Williams Hema Mistry Anne-Marie Slowther Katie Booth Ranjit Lall Debra Bick Siobhan Quenby SANJEEV DESHPANDE Joanne D Fisher Jason Gardosi Adam Gornall Adrian Willis Lauren Jade Ewington Ryan Griffin Kirsten Harris Emily Butler Kelly Fowler Jackie Dewdney Karen Hillyer |
| author_sort | Martin Underwood |
| collection | DOAJ |
| description | Introduction Large-for-gestational age (LGA) fetuses have an increased risk of shoulder dystocia. This can lead to adverse neonatal outcomes and death. Early induction of labour in women with a fetus suspected to be macrosomic may mitigate the risk of shoulder dystocia. The Big Baby Trial aims to find if induction of labour at 38+0–38+4 weeks’ gestation, in pregnancies with suspected LGA fetuses, reduces the incidence of shoulder dystocia.Methods and analysis The Big Baby Trial is a multicentre, prospective, individually randomised controlled trial of induction of labour at 38+0 to 38+4 weeks’ gestation vs standard care as per each hospital trust (median gestation of delivery 39+4) among women whose fetuses have an estimated fetal weight >90th customised centile according to ultrasound scan at 35+0 to 38+0 weeks’ gestation. There is a parallel cohort study for women who decline randomisation because they opt for induction, expectant management or caesarean section. Up to 4000 women will be recruited and randomised to induction of labour or to standard care. The primary outcome is the incidence of shoulder dystocia; assessed by an independent expert group, blind to treatment allocation, from delivery records. Secondary outcomes include birth trauma, fractures, haemorrhage, caesarean section rate and length of inpatient stay. The main trial is ongoing, following an internal pilot study. A qualitative reporting, health economic evaluation and parallel process evaluation are included.Ethics and dissemination The study received a favourable opinion from the South West—Cornwall and Plymouth Health Research Authority on 23/03/2018 (IRAS project ID 229163). Study results will be reported in the National Institute for Health Research journal library and published in an open access peer-reviewed journal. We will plan dissemination events for key stakeholders.Trial registration number ISRCTN18229892. |
| first_indexed | 2024-04-11T08:08:34Z |
| format | Article |
| id | doaj.art-e190450a477b4448a26f1a3b07bfcaa0 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-11T08:08:34Z |
| publishDate | 2022-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-e190450a477b4448a26f1a3b07bfcaa02022-12-22T04:35:28ZengBMJ Publishing GroupBMJ Open2044-60552022-11-01121110.1136/bmjopen-2021-058176Induction of labour for predicted macrosomia: study protocol for the ‘Big Baby’ randomised controlled trialMartin Underwood0Sara Wood1Stavros Petrou2Jaclyn Brown3Simon Gates4Ceri Jones5Mandy Williams6Hema Mistry7Anne-Marie Slowther8Katie Booth9Ranjit Lall10Debra Bick11Siobhan Quenby12SANJEEV DESHPANDE13Joanne D Fisher14Jason Gardosi15Adam Gornall16Adrian Willis17Lauren Jade Ewington18Ryan Griffin19Kirsten Harris20Emily Butler21Kelly Fowler22Jackie Dewdney23Karen Hillyer24Warwick Clinical Trials Unit, Warwick Medcial School, University of Warwick, Coventry, UKWarwick Clinical Trials Unit, Warwick Medcial School, University of Warwick, Coventry, UKNuffield Department of Primary Care Health Sciences, Oxford, UKWarwick Clinical Trials Unit, Warwick Medcial School, University of Warwick, Coventry, UKCancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UKUniversity Hospitals Coventry and Warwickshire NHS Trust, Coventry, UKPerinatal Institute, Birmingham, UKWarwick Clinical Trials Unit, Warwick Medcial School, University of Warwick, Coventry, UKSocial Sciences and Systems in Health, University of Warwick, Coventry, UKWarwick Clinical Trials Unit, Warwick Medcial School, University of Warwick, Coventry, UKWarwick Clinical Trials Unit, Warwick Medcial School, University of Warwick, Coventry, UKWarwick Clinical Trials Unit, Warwick Medcial School, University of Warwick, Coventry, UKBiomedical Sciences, University of Warwick Faculty of Medicine, Coventry, UKShrewsbury and Telford Hospital NHS Trust, Shrewsbury, UKWarwick Clinical Trials Unit, Warwick Medcial School, University of Warwick, Coventry, UKPerinatal Institute, Birmingham, UKShrewsbury and Telford Hospital NHS Trust, Shrewsbury, UKWarwick Clinical Trials Unit, Warwick Medcial School, University of Warwick, Coventry, UKBiomedical Sciences, University of Warwick Faculty of Medicine, Coventry, UKWarwick Clinical Trials Unit, Warwick Medcial School, University of Warwick, Coventry, UKWarwick Clinical Trials Unit, Warwick Medcial School, University of Warwick, Coventry, UKPerinatal Institute, Birmingham, UKPerinatal Institute, Birmingham, UKErb’s Palsy Group, Coventry, UKErb’s Palsy Group, Coventry, UKIntroduction Large-for-gestational age (LGA) fetuses have an increased risk of shoulder dystocia. This can lead to adverse neonatal outcomes and death. Early induction of labour in women with a fetus suspected to be macrosomic may mitigate the risk of shoulder dystocia. The Big Baby Trial aims to find if induction of labour at 38+0–38+4 weeks’ gestation, in pregnancies with suspected LGA fetuses, reduces the incidence of shoulder dystocia.Methods and analysis The Big Baby Trial is a multicentre, prospective, individually randomised controlled trial of induction of labour at 38+0 to 38+4 weeks’ gestation vs standard care as per each hospital trust (median gestation of delivery 39+4) among women whose fetuses have an estimated fetal weight >90th customised centile according to ultrasound scan at 35+0 to 38+0 weeks’ gestation. There is a parallel cohort study for women who decline randomisation because they opt for induction, expectant management or caesarean section. Up to 4000 women will be recruited and randomised to induction of labour or to standard care. The primary outcome is the incidence of shoulder dystocia; assessed by an independent expert group, blind to treatment allocation, from delivery records. Secondary outcomes include birth trauma, fractures, haemorrhage, caesarean section rate and length of inpatient stay. The main trial is ongoing, following an internal pilot study. A qualitative reporting, health economic evaluation and parallel process evaluation are included.Ethics and dissemination The study received a favourable opinion from the South West—Cornwall and Plymouth Health Research Authority on 23/03/2018 (IRAS project ID 229163). Study results will be reported in the National Institute for Health Research journal library and published in an open access peer-reviewed journal. We will plan dissemination events for key stakeholders.Trial registration number ISRCTN18229892.https://bmjopen.bmj.com/content/12/11/e058176.full |
| spellingShingle | Martin Underwood Sara Wood Stavros Petrou Jaclyn Brown Simon Gates Ceri Jones Mandy Williams Hema Mistry Anne-Marie Slowther Katie Booth Ranjit Lall Debra Bick Siobhan Quenby SANJEEV DESHPANDE Joanne D Fisher Jason Gardosi Adam Gornall Adrian Willis Lauren Jade Ewington Ryan Griffin Kirsten Harris Emily Butler Kelly Fowler Jackie Dewdney Karen Hillyer Induction of labour for predicted macrosomia: study protocol for the ‘Big Baby’ randomised controlled trial BMJ Open |
| title | Induction of labour for predicted macrosomia: study protocol for the ‘Big Baby’ randomised controlled trial |
| title_full | Induction of labour for predicted macrosomia: study protocol for the ‘Big Baby’ randomised controlled trial |
| title_fullStr | Induction of labour for predicted macrosomia: study protocol for the ‘Big Baby’ randomised controlled trial |
| title_full_unstemmed | Induction of labour for predicted macrosomia: study protocol for the ‘Big Baby’ randomised controlled trial |
| title_short | Induction of labour for predicted macrosomia: study protocol for the ‘Big Baby’ randomised controlled trial |
| title_sort | induction of labour for predicted macrosomia study protocol for the big baby randomised controlled trial |
| url | https://bmjopen.bmj.com/content/12/11/e058176.full |
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