Induction With Foley OR Misoprostol (INFORM) Study
Ключавыя словы
Рэферат
Апісанне
This is a pragmatic, open-label, randomised control trial of two methods for labour induction among women with pre-eclampsia. Women requiring delivery for preeclampsia in two hospitals in Nagpur, India will be randomised to one of two treatment groups: transcervical Foley catheter or oral misoprostol tablets.
Даты
Апошняя праверка: | 11/30/2015 |
Упершыню прадстаўлена: | 02/13/2013 |
Меркаваная колькасць заявак прадстаўлена: | 02/26/2013 |
Першае паведамленне: | 02/27/2013 |
Апошняе абнаўленне адпраўлена: | 12/10/2015 |
Апошняе абнаўленне апублікавана: | 12/13/2015 |
Фактычная дата пачатку даследавання: | 11/30/2013 |
Разліковая дата першаснага завяршэння: | 05/31/2015 |
Разліковая дата завяршэння даследавання: | 05/31/2015 |
Стан альбо хвароба
Ўмяшанне / лячэнне
Device: Foley Catheter
Drug: Misoprostol
Фаза
Групы ўзбраенняў
Рука | Ўмяшанне / лячэнне |
---|---|
Active Comparator: Misoprostol Group 2 will be induced using oral misoprostol tablets (25 mcg) every 2 hours for a maximum of 12 doses or until active labour commences. In primigravid women, if contractions have not commenced after 2 doses, the dosage may be increased to 50mcg every 2 hours. Once in labour (regular painful contractions with a cervical dilatation of at least 4cm) no more misoprostol will be used and artificial membrane rupture and/or oxytocin infusion will be used as clinically indicated. If labour has still not commenced after 24 hours, they will be deemed to have a 'failed induction' and the decision on further management will be made by the clinical team (their choice could include the use of repeat misoprostol, Foley catheter, dinoprostone, caesarean section or delay as deemed appropriate). | Drug: Misoprostol 25mcg every 2 hours for maximum of 12 doses |
Active Comparator: Foley Catheter Group 1 will undergo induction using a transcervical Foley catheter (silicone, size 18F with 30ml balloon) which will remain until active labour starts, the Foley catheter falls out, or 12 hours have elapsed. If the Foley catheter falls out within 12h, membranes will be ruptured and/or oxytocin infusion started. If the Foley catheter does not fall out within 12h, it will be removed at 12h and oxytocin commenced with an artificial rupture of membrane when possible. If labour has still not commenced after 24 hours, they will be deemed to have a 'failed induction' and the decision on further management will be made by the clinical team (their choice could include the use of misoprostol, repeat Foley catheter, dinoprostone, caesarean section or delay as deemed appropriate). | Device: Foley Catheter Transcervical Foley catheter (silicone, size 18F with 30ml balloon) |
Крытэрыі прыдатнасці
Узрост, які мае права на вучобу | 18 Years Каб 18 Years |
Пол, прыдатны для навучання | Female |
Прымае здаровых валанцёраў | Так |
Крытэрыі | Inclusion Criteria: - Ongoing pregnancies with a live fetus in whom the decision has been made to induce vaginal delivery because of preeclampsia or uncontrolled hypertension. Women will be included irrespective of whether an intrapartum caesarean section on fetal grounds or would be considered or not. - Women age ≥18 years - Signed informed consent form Exclusion Criteria: - • Women with previous caesarean sections - Those unable to give informed consent - Multiple pregnancy - History of allergy to misoprostol - Ruptured membranes - Chorioamnionitis (by clinical diagnosis) |
Вынік
Першасныя вынікі
1. Attainment of vaginal delivery within 24 hours. [24 hours]