Transdermal Clonidine in the Treatment of Severe Hyperemesis Gravidarum

Phase 3 Completed 13 enrolled A.O.U. Città della Salute e della Scienza

RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start: 2012-02
Primary completion: 2012-12
Completion: 2012-12

Outcome

Met primary endpoint

paper Transdermal clonidine led to a significantly greater improvement compared with placebo of the primary PMID 24684734 ↗

paper PUQE score P = 0.026 CI 0.43-3.24; VAS score P = 0.010 CI 2.17-12.83 PMID 24684734 ↗

Publications

Maina A, Arrotta M, Cicogna L, Donvito V, Mischinelli M, Todros T, Rivolo S. Transdermal clonidine in the treatment of severe hyperemesis. A pilot randomised control trial: CLONEMESI. BJOG. 2014 Nov;121(12):1556-62. doi: 10.1111/1471-0528.12757. Epub 2014 Apr 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Clonidine	Other / unclassified	5 mg	Other