Overview
Transdermal Clonidine in the Treatment of Severe Hyperemesis Gravidarum
Status:
Completed
Completed
Trial end date:
2012-12-01
2012-12-01
Target enrollment:
0
0
Participant gender:
Female
Female
Summary
CLONEMESI is an academic, independent, randomized placebo-controlled trial to assess the effect of transdermal (TD) clonidine in improving the symptoms of severe Hyperemesis Gravidarum(HG) affecting women in their 6th-12th week of pregnancy. The study has a crossover design.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Azienda Ospedaliera Città della Salute e della Scienza di TorinoTreatments:
Clonidine
Criteria
Inclusion Criteria:- Gestational age 6-12 weeks and a major grade of HG clinical severity defined as
follows:
- a PUQE score index ≥ 13 associated to one or more of the following conditions:
- weight loss > 5% of pregravidic weight,
- electrolyte disturbances,
- dehydration,
- duration of symptoms > 10 days ,
- inadequate food and drink intake
Exclusion Criteria:
- Language barrier.