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Sponsors and Collaborators: |
The Hospital for Sick Children Duchesnay Inc. |
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Information provided by: | The Hospital for Sick Children |
ClinicalTrials.gov Identifier: | NCT00293644 |
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 |
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. |
Estimated Enrollment: | 150 |
Study Start Date: | February 2006 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Gideon Koren, MD | 416-813-5778 | gkoren@sickkids.ca |
Contact: Alon Shrim, MD | 416-813-8130 | alon.shrim@utoronto.ca |
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 |
Principal Investigator: | Gideon Koren, MD | The Hospital for Sick Children |
Study ID Numbers: | 1000007791 |
Study First Received: | February 15, 2006 |
Last Updated: | August 2, 2006 |
ClinicalTrials.gov Identifier: | NCT00293644 |
Health Authority: | Canada: Health Canada |
Pregnancy Complications Hyperemesis Gravidarum Diclectin doxylamine succinate pyridoxine hydrochloride |
Hyperemesis Gravidarum Doxylamine succinate Signs and Symptoms Vomiting Pregnancy Complications |
Signs and Symptoms, Digestive Doxylamine Pyridoxine Nausea Vitamin B 6 |
Morning Sickness |