Transdermal Clonidine in the Treatment of Severe Hyperemesis Gravidarum

A.O.U. Città della Salute e della Scienza13 enrolled

Overview

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.

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 .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hyperemesis Gravidarum

Interventions

ClonidineDRUG

transdermal clonidine patch 5 mg q. 5 days

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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.

Locations (1)

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

Torino, Italy

Outcomes

Primary Outcomes

PUQE Score for Assessment of Severity in Hyperemesis Gravidarum

PUQE in an acronym for Pregnancy Unique Quantification of Emesis, a validated clinical score for assessment of severity of emesis in pregnancy. It is composed of three items; every item has a score from 1 (best) to 5 (worst). The sum range varies from 3 (best) to 15 (worst). Participants are followed for the whole duration of hospital stay (10 days) asking them to score their symptoms daily.

Time frame: Mean values of first period of five days are compared with mean values of second period of five days. Change is reported as baseline value - value at day 5 or at day 10.

VAS Score for Assessment of Severity in Hyperemesis Gravidarum

VAS is a Visual Analogic Scale formulated in 5 items. Every item has a score from 0 (best) to 10 (worst). The sum range swings from 0 (best ) to 50 (worst). Participants are followed for the whole duration of hospital stay (10 days) asking them to score their symptoms daily.

Time frame: Mean values of first period of five days are compared with mean values of second period of five days. Change is reported as baseline value - value at day 5 or at day 10.

Secondary Outcomes

Morning Urine Ketonuria

Morning urine ketonuria is a simple direct marker of starving associated to nausea and vomiting

Time frame: participants are followed for the whole duration of hospital stay (10 days) comparing the first period of 5 days with the second period of 5 days

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

The patients were randomly treated with and without TD clonidine (5mg patch) for 2 consecutive periods of 5 days , other antiemetic drugs (promethazine, prochlorperazine, metoclopramide, ondansetron) and anti reflux drugs (ranitidine, omeprazole) being administered on a scheduled or as-needed basis. All patients received intravenous hydration and supplementation with thiamine, during both periods. The use of steroids was allowed as a rescue medication in case of further worsening of symptoms.

Data from ClinicalTrials.gov

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