Transdermal Clonidine in the Treatment of Severe Hyperemesis Gravidarum

NCT01559012 | Completed Phase 3 Results

• 1 other identifier: Registro CE 409 det. 163/2012
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperemesis Gravidarum

Keywords

Hyperemesis Gravidarum; treatment; transdermal clonidine

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Secondary Outcomes (8)

• 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

Study Arms (2)

clonidine first - placebo second

OTHER

in this group patients are treated with transdermal clonidine first for 5 days then switch to placebo for 5 days

Drug: Clonidine

placebo first - clonidine second

OTHER

in this group patients are treated with placebo first for 5 days then with transdermal clonidine for next 5 days

Drug: Clonidine

Interventions

Clonidine DRUG

transdermal clonidine patch 5 mg q. 5 days

Also known as: Catapresan TTS 2 transdermal patch

clonidine first - placebo second; placebo first - clonidine second

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Language barrier.

Sponsors & Collaborators

• A.O.U. Città della Salute e della Scienza: lead

Study Sites (1)

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

Torino, 10126, Italy

Location

Related Publications (1)

• 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.

  PMID: 24684734 DERIVED

MeSH Terms

Conditions

Hyperemesis Gravidarum

Interventions

Clonidine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Efficacy and safety issues are represented by maternal exposure in a critical period for organogenesis and hypotensive effect of the drug. Findings based on a very limited number of women limit the reliability of results

Results Point of Contact

• Title: Dr. Aldo Maina M.D. Obstetric Medicine
• Organization: Città della Salute e della Scienza Ospedale Sant'Anna. Servizio di Medicina Interna

amaina@cittadellasalute.to.it

0039011313

Study Officials

• Aldo Maina, M.D.

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

  PRINCIPAL INVESTIGATOR

• Tullia Todros, M.D.

  Head . Dipartimento di Ostetricia e Neonatologia. Università di Torino.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Unit of Obstetric Medicine. Principal Investigator

Study Record Dates

• First Submitted: March 12, 2012
• First Posted: March 20, 2012
• Study Start: February 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 30, 2014
• Results First Posted: April 30, 2014

Record last verified: 2014-03

Locations

IT (1)