The CLONEMESI Study: a Randomized Placebo-controlled Study With Transdermal Clonidine in the Treatment of Severe Hyperemesis Gravidarum.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- PUQE Score for Assessment of Severity in Hyperemesis Gravidarum
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Language barrier.
研究组 & 干预措施
clonidine first - placebo second
in this group patients are treated with transdermal clonidine first for 5 days then switch to placebo for 5 days
干预措施: Clonidine (Drug)
placebo first - clonidine second
in this group patients are treated with placebo first for 5 days then with transdermal clonidine for next 5 days
干预措施: Clonidine (Drug)
结局指标
主要结局
PUQE Score for Assessment of Severity in Hyperemesis Gravidarum
时间窗: 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.
VAS Score for Assessment of Severity in Hyperemesis Gravidarum
时间窗: 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.
次要结局
- Diastolic Blood Pressure(10 days)
- Morning Urine Ketonuria(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.(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)
- Number of Days Off i.v. Therapy, the TD System (Clonidine/Placebo) Being Applied Only(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)
- Number of Patients Choosing Active Treatment for Off-label, Compassionate Use.(at 10 days since start of treatment)
- Pregnancy Outcome Measures: Birth Weight.(at delivery)
- Newborn Outcome Measure: APGAR Score.(at 1 minute and at 5 minutes after delivery)
- Systolic Blood Pressure(10 days)
研究者
Aldo Maina
M.D. Unit of Obstetric Medicine. Principal Investigator
Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna