The Postpartum Haemorrhage (PPH) Butterfly Work Package 3
关键词
抽象
描述
The study will involve 5-10 healthy women who deliver their baby vaginally following Induction of Labour (IOL). The women will be given a short leaflet regarding the study. During their time on the Induction of Labour (IOL) Suite, women will be seen by a member of the research team, the research will be discussed with them and they will receive a Participant Information Sheet if they desire. The woman will also be shown a short video regarding the Postpartum Haemorrhage (PPH)Butterfly which is specifically for members of the public. After a discussion of the research, women will be asked to indicate in writing whether they may consider participation, whether they do not want to participate, or whether they are undecided but are happy to be asked again. Only those women who are considering participation, or who are happy to be asked again will be approached post-delivery. All of the women can be approached up to 72 hours post-delivery and asked if they wish to participate. If a woman has a vaginal delivery, a member of the research team will then attend the Delivery Suite, maternity theatre (the woman may have had an instrumental delivery in theatre) or the postnatal ward once informed by the midwife caring for her. They will clarify with the woman if she wishes to participate. Assuming the woman wishes to participate, informed, signed consent will be sought at this point and the device will be used, with a speculum examination taking place before and after use of the device.
If the device is of an incorrect size, then the device size will be changed before repeating the process with 5-10 more women. In this way the final recruitment number may be more than 10 in total.
日期
| 最后验证: | 02/28/2018 |
| 首次提交: | 02/11/2016 |
| 提交的预估入学人数: | 02/24/2016 |
| 首次发布: | 02/25/2016 |
| 上次提交的更新: | 03/02/2018 |
| 最近更新发布: | 03/05/2018 |
| 实际学习开始日期: | 02/29/2016 |
| 预计主要完成日期: | 02/28/2017 |
| 预计完成日期: | 03/31/2017 |
状况或疾病
干预/治疗
Device: Use of the PPH Butterfly
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Other: Use of the PPH Butterfly The PPH Butterfly will be inserted into the vagina of a healthy postnatal woman | Device: Use of the PPH Butterfly The PPH Butterfly is a simple, low cost device that has been developed to facilitate less invasive compression of the uterus in a PPH |
资格标准
| 有资格学习的年龄 | 16 Years 至 16 Years |
| 有资格学习的性别 | Female |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Women who have a vaginal delivery following induction of labour and who are within 72 hours of delivery. Exclusion Criteria: - Women assessed antenatally to have learning difficulties that may have the potential to impair their decision making - Women aged < 16 years of age - Women who cannot read or understand the level of English used in the study documentation - Women who've had a stillbirth (in this pregnancy) - Women who have undergone Female Genital Mutilation/vaginal surgery which is unreversed (assessed antenatally) - Women with clotting disorders; either longstanding or following intrapartum events - Women who have just had, or are having an ongoing PPH - Women in whom the third stage of labour is not complete (placenta remains in situ). - Women who have had a caesarean section |
结果
主要结果指标
1. Number of participants for whom the PPH Butterfly is the correct size [Up to 8 weeks]
