Transdermal Clonidine in the Treatment of Severe Hyperemesis Gravidarum (CLONEMESI)
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|ClinicalTrials.gov Identifier: NCT01559012|
Recruitment Status : Completed
First Posted : March 20, 2012
Results First Posted : April 30, 2014
Last Update Posted : April 30, 2014
|Study Design||Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment|
|Recruitment Details||Patients admitted to hospital for severe hyperemesis (HG) March - December 2012|
The crossover study design allows to compare in the same patient the response to different treatment schedules.
The assumption is that the condition treated is not changing over the time of observation.
The reported evidence in literature is that severe HG does not spontaneously improve till 14th week.
Efficacy and safety issues are represented by maternal exposure in a critical period for organogenesis and hypotensive effect of the drug.
Findings based on a very limited number of women limit the reliability of results