NCT00293644

Pre-emptive Treatment of Severe Nausea and Vomiting of Pregnancy

A Randomized, Open-Label, Study of Pre-emptive Diclectin® Treatment for Severe Nausea and Vomiting of Pregnancy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Hyperemesis Gravidarum
• Pregnancy

Interventions

Type	Name	Description
DRUG	Diclectin®	Participants will begin with an initial dose of 20mg (2 tablets), taken at bedtime. The dose of Diclectin® will be adjusted to match symptoms.

Timeline

• Start date: 2006-02-01
• Primary completion: 2012-06-01
• Completion: 2015-06-01
• First posted: 2006-02-17
• Last updated: 2016-07-22

Locations

1 site across 1 country: Canada