| Scientific Title of Trial | Intra cervical Foley catheter versus oral misoprostol for pre induction cervical ripening of post dated pregnancies. A randomized controlled trial | |
| Public Title of Trial (in lay language) | Insertion of Foley catheter to uterine cervix versus oral misoprostol for preparation of uterine cervix for induction of labour in post dated pregnancies | |
| Acronym, if any | None | |
| Brief title, if any | None | |
| Any
other number(s) assigned to the trial and issuing authoruty, if any (eg. sponsor, other trial registry) |
Nil known | |
| Disease or Health Condition(s) studied | Effects of Foley catheter versus oral misoprostol for pre-induction cervical ripening | |
| What is the research question being addressed? | In women with post dated pregnancies is oral misoprostol better than insertion of intra-cervical Foley catheter for pre-induction ripening of the cervix? | |
| Study design | Randomized controlled trial | |
| Intervention(s) planned | Women will be randomly allocated to two groups by using stratified (primi/multi) block randomization at 40 weeks and 6 days. One group will have the Foley catheter inserted and the other group will have two doses of oral misoprostol 25 micro grams 4 hours apart. | |
| Inclusion criteria | Consecutive women with uncomplicated singleton pregnancies having a cephalic presentation at period of gestation of 40 weeks and 6 days | |
| Exclusion criteria | Complicated pregnancies – both maternal or fetal complications. Pregnancies with uncertain dates not confirmed by early scan, even though clinically considered as 41 weeks. Multiple pregnancies. Pregnancies with contraindication for normal vaginal delivery. Pregnancies with previous caesarean section. Women who have had insertion of intra cervical Foley catheter or vaginal PGE2 before 40 + 6 days. Contraindication for the use of misoprostol. | |
| Target number / sample size | 150 | |
| Primary outcome(s) | 1. Proportions establishing labour by day two after the intervention 2. Proportions of women suitable for induction of labour with modified Bishop score (mBS) 6 or more by day two after the intervention 3. Induction to delivery interval |
|
| Primary outcome(s) - time of assessment(s) | Morning of day 2 | |
| Secondary outcome(s) | 1. Induction to delivery interval 2. Mode of delivery 3. Side effects of misoprostol therapy |
|
| Secondary outcome(s) - time of assessment(s) | After delivery | |
| Countries of recruitment | Sri Lanka | |
| Anticipated start date | 01/02/2011 | |
| Anticipated end date | 10/01/2012 | |
| Recruitment status | Current | |
| State of ethics review approval | Ethical approval was obtained from the Ethical Review Committee of the University of Ruhuna, Galle | |
| Funding source(s) | None | |
| Applicant's Email | malikg@eureka.lk | |
| Approval Status | Approved | |
| Contact Person for Scientific Queries / Principal investigator | Prof. Malik Goonewardene
Senior Professor and Head of the Dept. of Obstetrics and Gynaecology University of Ruhuna, Faculty of Medicine, Galle, (091) 2246878, 2234801/3, 2234730 (091) 2222314, Int: (+94) malikg@eureka.lk |
|
| Primary Study Sponsor/ Organization | University of Ruhuna
Faculty of Medicine, P.O. Box 70, Galle (091) 2246878, 2234801/3, 2234730 94 91 2222314 malikg@eureka.lk www.medi.ruh.ac.lk |
|
| Contact Person for Public Queries | Prof. Malik Goonewardene Senior Professor and Head of the Dept. of Obstetrics and Gynaecology University of Ruhuna, Faculty of Medicine, Galle (091) 2246878, 2234801/3, 2234730 (091) 2222314, Int: (+94) malikg@eureka.lk |
|
| Secondary Study Sponsor(s), (if any) | None |
|
