Transdermal Clonidine in the Treatment of Severe Hyperemesis Gravidarum

Condition(s) targeted: Hyperemesis Gravidarum

Intervention: Clonidine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Azienda Ospedaliera Città della Salute e della Scienza di Torino

Official(s) and/or principal investigator(s):
Aldo Maina, M.D., Principal Investigator, Affiliation: Dipartimento di Ostetricia e Neonatologia. Servizio di Medicina Interna. Ospedale Sant'Anna Torino
Tullia Todros, M.D., Study Chair, Affiliation: Head . Dipartimento di Ostetricia e Neonatologia. Università di Torino.

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

PUQE Score for Assessment of Severity in Hyperemesis Gravidarum

VAS Score for Assessment of Severity in Hyperemesis Gravidarum

Secondary outcome:

Morning Urine Ketonuria

Daily Doses of Standard Antiemetic Drugs Required in the Two Different Periods.

Number of Days Off i.v. Therapy, the TD System (Clonidine/Placebo) Being Applied Only

Number of Patients Choosing Active Treatment for Off-label, Compassionate Use.

Pregnancy Outcome Measures: Birth Weight.

Newborn Outcome Measure: APGAR Score.

Systolic Blood Pressure

Diastolic Blood Pressure

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 .

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

Criteria:

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.

Ospedale Sant'Anna. Dipartimento di Ostetricia e Neonatologia. Servizio di Medicina Interna, Torino 10126, Italy

Starting date: February 2012
Last updated: March 31, 2014