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Completed

NCT Number: NCT01559012

Transdermal Clonidine in the Treatment of Severe Hyperemesis Gravidarum

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.

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Key information

Conditions

Hyperemesis Gravidarum Female Urogenital Diseases and Pregnancy Complications Morning Sickness Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Signs and Symptoms, Digestive Urogenital Diseases Vomiting

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

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

Torino, 10126, Italy

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clonidine

Drug

transdermal clonidine patch 5 mg q. 5 days

Other names: Catapresan TTS 2 transdermal patch

Primary outcomes

  1. PUQE Score for Assessment of Severity in Hyperemesis Gravidarum

    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.

    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.

  2. VAS Score for Assessment of Severity in Hyperemesis Gravidarum

    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 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.

Secondary outcomes

  1. Morning Urine Ketonuria

    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

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

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

    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

    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.

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

    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

    if the symptoms improve the patient and her doctors may decide to stop parenteral drugs continuing the TD system therapy.

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

    Time frame: at 10 days since start of treatment

    the patients were asked to choose between two transdermal systems (active drug versus placebo) as the most effective

  5. Pregnancy Outcome Measures: Birth Weight.

    Time frame: at delivery

    Birth weight adjusted for gestational age at delivery is a measure of pregnancy outcome after treatment of HG.

  6. Newborn Outcome Measure: APGAR Score.

    Time frame: at 1 minute and at 5 minutes after delivery

    The APGAR score is the most common indicator of neonatal status immediately after delivery.

    The test is done by a doctor, midwife, or nurse. The health care provider will examine the baby's:

    Breathing effort Heart rate Muscle tone Reflexes Skin color Each category is scored with 0, 1, or 2, depending on the observed condition. The APGAR rating is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth.

  7. Systolic Blood Pressure

    Time frame: 10 days

    Systolic BP was measured every day during the clonidine treatment (5 days) and placebo (5 days)

  8. Diastolic Blood Pressure

    Time frame: 10 days

    Diastolic BP was recorded every day during clonidine (5 days) and placebo (5 days) cycle

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: CLONEMESI

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 20, 2012
Registry last updated
Apr 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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