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Transdermal Clonidine in the Treatment of Severe Hyperemesis Gravidarum

NCT ID: NCT01559012

Last Updated: 2014-04-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-12-31

Brief Summary

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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

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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

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Hyperemesis Gravidarum

Keywords

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Hyperemesis Gravidarum treatment transdermal clonidine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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clonidine first - placebo second

in this group patients are treated with transdermal clonidine first for 5 days then switch to placebo for 5 days

Group Type OTHER

Clonidine

Intervention Type DRUG

transdermal clonidine patch 5 mg q. 5 days

placebo first - clonidine second

in this group patients are treated with placebo first for 5 days then with transdermal clonidine for next 5 days

Group Type OTHER

Clonidine

Intervention Type DRUG

transdermal clonidine patch 5 mg q. 5 days

Interventions

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Clonidine

transdermal clonidine patch 5 mg q. 5 days

Intervention Type DRUG

Other Intervention Names

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Catapresan TTS 2 transdermal patch

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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A.O.U. Città della Salute e della Scienza

OTHER

Sponsor Role lead

Responsible Party

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Aldo Maina

M.D. Unit of Obstetric Medicine. Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aldo Maina, M.D.

Role: PRINCIPAL_INVESTIGATOR

Dipartimento di Ostetricia e Neonatologia. Servizio di Medicina Interna. Ospedale Sant'Anna Torino

Tullia Todros, M.D.

Role: STUDY_CHAIR

Head . Dipartimento di Ostetricia e Neonatologia. Università di Torino.

Locations

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Ospedale Sant'Anna. Dipartimento di Ostetricia e Neonatologia. Servizio di Medicina Interna

Torino, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 24684734 (View on PubMed)

Other Identifiers

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Registro CE 409 det. 163/2012

Identifier Type: -

Identifier Source: org_study_id