Amendments
Please find below all site relevant amendments for the Big Baby Trial.
Please note sites are only required to file the amendments applicable to their site.
Substantial Amendments
| No | Summary | Date | Documents |
| 1 | Addition of questionnaires & various updates to Protocol, PIS, Consent forms & other documents. | 17/04/18 | |
| 2 | Various updates to Protocol, PIS, Interview Study, Consent forms & Poster. | 18/09/18 | |
| 3 | Urgent Safety Measure | 01/11/18 | |
| 4 | Updates to Protocol, PIS & Shoulder Dystocia Risk letter. | 17/12/18 | |
| 5 | Update to PIS. | 28/02/19 | |
| 6 | Update to Protocol & Trifold leaflet. Addition of Questionnaire cover letter, poster 1 & clinician poster. | 28/05/19 | |
| 7 | Update to Protocol & PIS. Addition of telephone questionnaires. | 18/02/20 | |
| 8 | Change to recruitment procedures due to COVID-19 | 30/06/20 | |
| 9 | Addition of BB2Up & combined 2/6 month questionnaire | 27/04/21 | |
| 10 | Document updates to allow the trial to stop cohort recruitment | 08/02/22 | |
| 11 | BigBaby 2 Up process & documentation updates | 30/06/22 | |
| 12 | Addition of BB2Up Paper Questionnaire | 31/01/23 | |
| 13 | Update to publishing and dissemination section of protocol and update to timelines. Confirmation of change in participant numbers. | 05/06/23 |
Non-Substantial Amendments
| No | Summary | Date | Documents |
| 1 |
Addition of new sites. |
14/05/18 | |
| 2 |
Addition of new sites. |
14/06/18 | |
| 3 |
Addition of watermark to the RCT & Cohort consent form and changes to the format to the contact details section of Information leaflet. |
21/06/18 | |
| 4 |
Addition of new sites. |
23/07/18 | |
| 5 |
Addition of new sites. |
19/07/18 | |
| 6 |
Addition of new sites. |
14/08/18 | |
| 7 |
Addition of new sites. |
11/10/18 | |
| 8 | Change of PI at North Tees and Hartlepool Hospitals NHS Foundation Trust. | 18/10/18 | |
| 9 |
Update to baseline questionnaire, Two Month Follow Up Questionnaire A, Two Month Follow Up Questionnaire B, Six Month Follow Up Questionnaire A & Six Month Follow Up Questionnaire B. |
30/10/18 | |
| 10 | RCT & Cohort Consent form: Points 13 and 14 have been amended to state that the HES and ONS data will be accessed via the information and statistics division for Scotland rather than NHS digital. | 10/01/19 | |
| 11 | Addition of new sites. | 17/01/19 | |
| 12 |
Updates to Baseline Questionnaire, Two Mont Follow-Up Questionnaires A & B, Six Month Follow-Up Questionnaires A & B. |
26/03/19 | |
| 13 | Addition of new sites. | 28/03/19 | |
| 14 | Update to Big Baby Trial Poster to be more eye catching to potential participants. | 18/04/19 | |
| 15 | Addition of new sites. | 1/05/19 | |
| 16 | Addition of new sites. | 21/06/19 | |
| 17 | Addition of new sites. | 30/07/19 | |
| 18 | Change of PI at Sherwood. | 24/10/19 | |
| 19 | Addition of new sites. | 24/10/19 | |
| 20 | Trust name change North Cumbria. | 08/11/19 | |
| 21 | Addition of new sites. | 05/11/19 | |
| 22 | Change of PI at Lancashire. | 18/11/19 | |
| 23 | Change of PI at Imperial. | 17/12/19 | |
| 24 | Change of PI at Birmingham. | 09/12/19 | |
| 25 | Addition of new sites. | 20/01/20 | |
| 26 | Change of PI at Ormskirk. | 31/03/20 | |
| 27 | COVID-19 changes to working pattern and process of sending out follow up questionnaires – not implemented. | 02/04/20 | |
| 28 | COVID-19 changes to working pattern and process of sending out follow up questionnaires. | 22/05/20 | |
| 29 | Change of PI at Middlesex. | 16/06/20 | |
| 30 | Change of PI at Sherwood. | 30/06/20 | |
| 31 | Change of PI at UHCW. | 02/09/20 | |
| 32 | Change of PI at East Lancashire. | 03/09/20 | |
| 33 | Change of PI Burton. | 19/10/20 | |
| 34 | Addition of updated documents to research clinician’s sub study documents. | 15/12/20 | |
| 35 | Approval of translated documents (PIS and IC). | 11/12/20 | |
| 36 | Change PI E Lancs. | 16/12/20 | |
| 37 | Change PI Countess of Chester. | 16/02/21 | |
| 38 | Change PI Pennine acute. | 11/05/21 | |
| 39 | Change PI temp w. sussex. | 14/05/21 | |
| 40 | Extension of recruitment timelines. | 24/05/21 | |
| 41 | Change of PI Warwick. | 10/06/21 | |
| 42 | Approval of translated documents (PIS). | 27/07/21 | |
| 43 | Change in PI Ysbyty Gwynedd. | 17/08/21 | |
| 44 | Temporary PI Burton. | 20/08/21 | |
| 45 | Change in PI Countess of Chester | 20/11/21 | |
| 46 | Addition of new site. | 18/03/22 | |
| 47 | BB2Up sub study change to invitation email. | 26/04/22 | |
| 48 | BB2Up sub study change to Participant information sheet GDPR wording. | 26/04/22 | |
| 49 | Change in PI West Hertfordshire. | 03/05/22 | |
| 50 | Translations PIS v9.0. | 06/05/22 | |
| 51 | Addition of PI to Darlington Memorial Hospital. | 16/08/22 | |
| 52 | Update of Study documents for Big Baby 2 up. | 04/11/22 | |
| 53 | Update of Study documents for Big Baby 2 up. | 17/03/23 | |
| 55 | Addition of thank you vouchers to Big Baby 2 Up | 05/07/23 | |
| 56 | Addition of Big Baby 2 Up Voucher attachment | 31/08/23 |
