Hyperemesis Gravidarum Clinical Trial
— CLONEMESIOfficial title:
The CLONEMESI Study: a Randomized Placebo-controlled Study With 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.
Status | Completed |
Enrollment | 13 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Ospedale Sant'Anna. Dipartimento di Ostetricia e Neonatologia. Servizio di Medicina Interna | Torino |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Città della Salute e della Scienza di Torino |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
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. | No |
Primary | 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. | 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. | No |
Secondary | Morning Urine Ketonuria | Morning urine ketonuria is a simple direct marker of starving associated to nausea and vomiting | 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 | No |
Secondary | 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. |
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 | No |
Secondary | Number of Days Off i.v. Therapy, the TD System (Clonidine/Placebo) Being Applied Only | if the symptoms improve the patient and her doctors may decide to stop parenteral drugs continuing the TD system therapy. | 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 | No |
Secondary | Number of Patients Choosing Active Treatment for Off-label, Compassionate Use. | the patients were asked to choose between two transdermal systems (active drug versus placebo) as the most effective | at 10 days since start of treatment | No |
Secondary | Pregnancy Outcome Measures: Birth Weight. | Birth weight adjusted for gestational age at delivery is a measure of pregnancy outcome after treatment of HG. | at delivery | Yes |
Secondary | Newborn Outcome Measure: APGAR Score. | 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. |
at 1 minute and at 5 minutes after delivery | Yes |
Secondary | Systolic Blood Pressure | Systolic BP was measured every day during the clonidine treatment (5 days) and placebo (5 days) | 10 days | Yes |
Secondary | Diastolic Blood Pressure | Diastolic BP was recorded every day during clonidine (5 days) and placebo (5 days) cycle | 10 days | Yes |
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