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

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

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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