NCT01559012

Transdermal Clonidine in the Treatment of Severe Hyperemesis Gravidarum

The CLONEMESI Study: a Randomized Placebo-controlled Study With Transdermal Clonidine in the Treatment of Severe Hyperemesis Gravidarum.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: A.O.U. Città della Salute e della Scienza · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

Setting. The trial is performed at a single hospital setting after admission of patients. Ethics. The study has been approved by our local Ethics Committee and women are requested to sign an informed consent. No pharmaceutical company is involved in any phases of the trial including protocol design, study conduction, coordination and monitoring, data handling and analysis. Randomization. The patients are allocated to a random list to receive first placebo and then TD clonidine or the other way round. Blinding. Neither the patients nor their attending caregivers know the order of administration . The outcome assessors are blinded as well. Treatment.The patients are randomly treated with and without TD clonidine for 2 consecutive periods of 5 days , other antiemetic drugs (promethazine, metoclopramide, ondansetron) and anti- reflux drugs (ranitidine, omeprazole) being administered on a scheduled or as-needed basis. All patients receive intravenous hydration and supplementation with thiamine. Assessment. Physical condition of patients are assessed daily: blood pressure (lying and standing), body weight, morning ketonuria. Two different clinical self administered scores as PUQE (Pregnancy Unique Quantification of Emesis) and VAS (Visual Analogue Scale) are employed to check daily the intensity of symptoms and the sense of wellbeing. The consumption of antiemetic and anti-reflux drugs administered in the two periods is monitored .

Conditions

• Hyperemesis Gravidarum

Interventions

Type	Name	Description
DRUG	Clonidine	transdermal clonidine patch 5 mg q. 5 days

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-03-20
• Last updated: 2014-04-30
• Results posted: 2014-04-30

Locations

1 site across 1 country: Italy