Overview

Transdermal Clonidine in the Treatment of Severe Hyperemesis Gravidarum

Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
0
Participant gender:
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 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Treatments:
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.