Prostin and Propess in Induction of Labor
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|ClinicalTrials.gov Identifier: NCT01635439|
Recruitment Status : Completed
First Posted : July 9, 2012
Results First Posted : October 4, 2012
Last Update Posted : February 6, 2014
|Condition or disease||Intervention/treatment||Phase|
|Labor Pain||Drug: Propess Drug: Prostin E2||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Induction of Labour: A Comparison Between Propess Vaginal Delivery System and Prostin E2 Vaginal Suppositories, A Randomized Controlled Trial.|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||December 2011|
Active Comparator: Propess
Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h.
The vaginal insert is removed 24 h after the application. It is only to be removed earlier in case of the onset of active labour, the rupture of the membranes, or at the occurrence of hyperstimulation.
Other Name: Intravaginal PGE2 insert
Active Comparator: Prostin E2
PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
Drug: Prostin E2
3 mg tab is placed in the posterior vaginal fornix. dose can be repeated every 6 hours till onset of active labour, the rupture of the membranes, or the occurrence of hyper-stimulation.
Other Name: Dinoprostone (PGE2)vaginal tablets.
- Induction to Delivery Interval [ Time Frame: 24 hours ]
- Induction to Onset of Labor Interval [ Time Frame: 24 hours ]
- Uterine Hyper-stimulation Rate [ Time Frame: 24 hours ]
- Need for Syntocinon Augmentation [ Time Frame: 24 hours ]
- Normal Vaginal Delivery Rate [ Time Frame: 24 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01635439
|NWAFH, North west Armed Forces Hospital|
|Tabuk, Saudi Arabia, Box 100 Tabuk|
|Principal Investigator:||Ahmed Abdelaziz, M.D.||North West Armed Forces Hospital|