Clinical trial NCT01559012: Transdermal Clonidine in the Treatment of Severe Hyperemesis Gravidarum
Official title: The CLONEMESI Study: a Randomized Placebo-controlled Study With Transdermal Clonidine in the Treatment of Severe Hyperemesis Gravidarum.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperemesis Gravidarum
Keywords: Hyperemesis Gravidarum
treatment
transdermal clonidine
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
First posted: 2012-03-20
Enrollment: 13
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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: 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 .

Eligibility 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.

Primary outcomes:
measure: PUQE Score for Assessment of Severity in Hyperemesis Gravidarum
timeFrame: 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.
measure: VAS Score for Assessment of Severity in Hyperemesis Gravidarum
timeFrame: 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:
measure: Morning Urine Ketonuria
timeFrame: 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
measure: Daily Doses of Standard Antiemetic Drugs Required in the Two Different Periods.
timeFrame: 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
measure: Number of Days Off i.v. Therapy, the TD System (Clonidine/Placebo) Being Applied Only
timeFrame: 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
measure: Number of Patients Choosing Active Treatment for Off-label, Compassionate Use.
timeFrame: at 10 days since start of treatment
measure: Pregnancy Outcome Measures: Birth Weight.
timeFrame: at delivery
measure: Newborn Outcome Measure: APGAR Score.
timeFrame: at 1 minute and at 5 minutes after delivery
measure: Systolic Blood Pressure
timeFrame: 10 days
measure: Diastolic Blood Pressure
timeFrame: 10 days
Other outcomes:
Locations:
city: Torino
country: Italy
facility: Ospedale Sant'Anna. Dipartimento di Ostetricia e Neonatologia. Servizio di Medicina Interna
Study officials:
affiliation: Dipartimento di Ostetricia e Neonatologia. Servizio di Medicina Interna. Ospedale Sant'Anna Torino
name: Aldo Maina, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Head . Dipartimento di Ostetricia e Neonatologia. Università di Torino.
name: Tullia Todros, M.D.
role: STUDY_CHAIR
References:
citation: 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.