Sublingual Misoprostol for Induction of Labor (SUBMISO)
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|ClinicalTrials.gov Identifier: NCT01406392|
Recruitment Status : Unknown
Verified March 2011 by Professor Fernando Figueira Integral Medicine Institute.
Recruitment status was: Recruiting
First Posted : August 1, 2011
Last Update Posted : August 1, 2011
|Condition or disease||Intervention/treatment||Phase|
|Labor Induced||Drug: Misoprostol 25mcg Drug: Sublingual Misoprostol||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Sublingual Misoprostol 12,5 Mcg Versus Vaginal Misoprostol 25 Mcg for Induction of Labour of Alive and Term Fetus : Randomized Controlled Trial|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||July 2011|
|Estimated Study Completion Date :||December 2011|
Active Comparator: Sublingual Misoprostol 12,5mcg
Sublingual misoprostol or placebo tablete will be administered for each six hours until the maximum dose of 100mcg or eight tablets.
Drug: Sublingual Misoprostol
Sublingual misoprostol or placebo tablets will be administered for each six hours until the maximum dose of 100mcg or eight tablets
Active Comparator: Vaginal Misoprostol 25 mcg
Vaginal misoprostol or placebo tablets will be administered for each six hours until the maximum dose of 200mcg or eight tablets. Each pacient will receve at the same time a sublingual placebo tablet and vaginal misoprostol or sublingual misoprostol and vaginal placebo tablet. It will depend of the randomization.
Drug: Misoprostol 25mcg
Vaginal misoprostol or placebo tablets will be administered for each six hours until the maximum dose of 200mcg or eight tablets.
Other Name: Prostokos Cytotec
- Frequency of taquissistoly [ Time Frame: 48 hours ]during 48 hours the presence of taquissistoly will be observed
- Hyperstimulation Syndrome [ Time Frame: 48 hours ]during 48 hours the presence of hyperstimulation syndrome will be observed
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): NCT01406392
|Contact: Daniele SM Gattás, MD student||55 81 email@example.com|
|Contact: : Alex SR Souza, PhD firstname.lastname@example.org|
|Instituto de Medicina Integral Professor Fernando Figueira (IMIP)||Recruiting|
|Recife, Pernambuco, Brazil, 50070-550|
|Contact: Daniele SM Gattás, MD Student 55 81 88986853 email@example.com|