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Pre-Emptive Treatment of Severe Nausea and Vomiting of Pregnancy.
This study is currently recruiting participants.
Verified by The Hospital for Sick Children, August 2006
Sponsors and Collaborators: The Hospital for Sick Children
Duchesnay Inc.
Information provided by: The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00293644
  Purpose

The purpose of this study is to determine whether pre-emptive use of a delayed release combination of pyridoxine hydrochloride and doxylamine succinate (Diclectin®), before eruption of symptoms of Nausea and vomiting of pregnancy and hyperemesis gravidarum, will reduce the incidence of severe forms of this syndrome/HG.


Condition Intervention Phase
Hyperemesis Gravidarum
Pregnancy
Drug: Diclectin
Phase III

MedlinePlus related topics: Nausea and Vomiting
Drug Information available for: Vitamin B 6 5-Hydroxy-6-methyl-3,4-pyridinedimethanol hydrochloride Pyridoxine Succinic acid Doxylamine succinate Doxylamine
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: A Randomized, Open-Label, Study of Pre-Emptive Diclectin® Treatment for Severe Nausea and Vomiting of Pregnancy.

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Severity of nausea and vomiting of pregnancy and hyperemesis gravidarum (HG) as measured every two weeks by the Pregnancy-Unique Quantification of Emesis and nausea (PUQE) scoring system
  • Incidence of NVP and HG in current vs. previous pregnancy

Estimated Enrollment: 150
Study Start Date: February 2006
Detailed Description:

Nausea and vomiting of pregnancy (NVP) affects up to 80% of pregnant women, persists throughout pregnancy in 20% of women. 1%-3% of pregnant women experience the extreme form called hyperemesis gravidarum (HG), described as intractable vomiting associated with weight loss of more than 5% of pre-pregnancy weight, dehydration and electrolyte imbalances which may lead to hospitalization. Treatment involves administration of antiemetics once NVP occurs. Although there is wide evidence of fetal safety of several antiemetic medications, women and health professionals are often reluctant to use antiemetics due to a heightened misperception of teratogenic risk. Diclectin® is a prescription drug in Canada specifically indicated for treatment of NVP. Our preliminary research has shown Diclectin® to be effective for pre-emptive treatment for NVP symptoms in women who experienced severe NVP/HG in their previous pregnancy. This study will evaluate the effectiveness of Diclectin as a pre-emptive treatment for NVP and HG in a randomized controlled trial. In the Pre-emptive Treatment Group, as soon as a patient becomes aware of the present pregnancy, and before the NVP starts, she will take an initial Diclectin® dose, followed by standard dosing to match symptoms once NVP develops. In the Standard Treatment Group women will take Diclectin® only at appearance of symptoms. A natural history control group will also be included. This study will determine whether pre-emptive use of Diclectin will reduce the incidence of severe forms of this syndrome/HG.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Singleton pregnancy of less than 7 weeks gestation.
  • Women who previously carried a full term pregnancy.
  • Severe NVP/HG in previous pregnancy by verbal confirmation as determined by questionnaire

Exclusion Criteria:

  • Women who refuse to participate in the study/sign a written concent
  • Women with insufficient English language skills to understand the questionnaires and assessment material
  • Women in her first pregnancy
  • Women who didn’t suffer severe NVP/HG in previous pregnancy
  • Gestational age beyond 7w+0d weeks of pregnancy
  • Multiple gestation
  • Women who have had previous adverse effects to “Diclectin®”
  • Women who take another anti-emetic medication
  • Pregnant women younger than 18 years.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00293644

Contacts
Contact: Gideon Koren, MD 416-813-5778 gkoren@sickkids.ca
Contact: Alon Shrim, MD 416-813-8130 alon.shrim@utoronto.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Gideon Koren, MD     416-813-5778     gkoren@sickkids.ca    
Contact: Alon Shrim, MD     416-813-8130     alon.shrim@utoronto.ca    
Principal Investigator: Gideon Koren, MD            
Sub-Investigator: Alon Shrim, MD            
Sponsors and Collaborators
The Hospital for Sick Children
Duchesnay Inc.
Investigators
Principal Investigator: Gideon Koren, MD The Hospital for Sick Children
  More Information

Study ID Numbers: 1000007791
Study First Received: February 15, 2006
Last Updated: August 2, 2006
ClinicalTrials.gov Identifier: NCT00293644  
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
Pregnancy Complications
Hyperemesis Gravidarum
Diclectin
doxylamine succinate
pyridoxine hydrochloride

Study placed in the following topic categories:
Hyperemesis Gravidarum
Doxylamine succinate
Signs and Symptoms
Vomiting
Pregnancy Complications
Signs and Symptoms, Digestive
Doxylamine
Pyridoxine
Nausea
Vitamin B 6

Additional relevant MeSH terms:
Morning Sickness

ClinicalTrials.gov processed this record on January 14, 2009