Transdermal Clonidine in the Treatment of Severe Hyperemesis Gravidarum (CLONEMESI)

A

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Status and phase

Completed
Phase 3

Conditions

Hyperemesis Gravidarum

Treatments

Drug: Clonidine

Study type

Interventional

Funder types

Other

Identifiers

NCT01559012
Registro CE 409 det. 163/2012

Details and patient eligibility

About

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.

Full 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 .

Enrollment

13 patients

Sex

Female

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

13 participants in 2 patient groups

clonidine first - placebo second
Other group
Description:
in this group patients are treated with transdermal clonidine first for 5 days then switch to placebo for 5 days
Treatment:
Drug: Clonidine
placebo first - clonidine second
Other group
Description:
in this group patients are treated with placebo first for 5 days then with transdermal clonidine for next 5 days
Treatment:
Drug: Clonidine

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems