Phase 3
N=13
Transdermal Clonidine in the Treatment of Severe Hyperemesis Gravidarum
Hyperemesis Gravidarum
Bottom Line
View on ClinicalTrials.gov: NCT01559012 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: PUQE Score for Assessment of Severity in Hyperemesis Gravidarum — 6.3; 8.5 units on a scale — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Clonidine (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- A.O.U. Città della Salute e della Scienza
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PUQE Score for Assessment of Severity in Hyperemesis Gravidarum |
6.3; 8.5 | 0.001 sig |
| PRIMARY VAS Score for Assessment of Severity in Hyperemesis Gravidarum |
22; 29 | 0.009 sig |
| SECONDARY Morning Urine Ketonuria |
0.06; 0.36 | 0.000 sig |
| SECONDARY Daily Doses of Standard Antiemetic Drugs Required in the Two Different Periods. |
1.5; 2.3 | 0.013 sig |
| SECONDARY Number of Days Off i.v. Therapy, the TD System (Clonidine/Placebo) Being Applied Only |
0.40; 0.20 | 0.051 |
| SECONDARY Number of Patients Choosing Active Treatment for Off-label, Compassionate Use. |
9; 3 | 0.0089 sig |
| SECONDARY Pregnancy Outcome Measures: Birth Weight. |
3312 | — |
| SECONDARY Newborn Outcome Measure: APGAR Score. |
9; 9 | — |
| SECONDARY Systolic Blood Pressure |
91; 97 | 0.01 sig |
| SECONDARY Diastolic Blood Pressure |
58; 61 | 0.055 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01559012). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.