Safety of mass-based Diclectin dosing for nausea and vomiting of pregnancy: an open-label treatment study

Z. Levichek
Division of Clinical Pharmacology/Toxicology, University of Toronto and the Motherisk Program, the Hospital for Sick Children, Toronto, Ontario, Canada

Supported by a grant from Duchesnay Inc., Laval, Quebec

Nausea and vomiting are so common in the first trimester of pregnancy that they are almost diagnostic of pregnancy. Symptoms are usually mild in nature and restricted to 7-12 weeks' gestation in all but the fewer than 1% of women who develop hyperemesis gravidarum, which is characterized by particularly severe physical symptoms and medical complications. Diclectin is the drug of choice for NVP (Nausea and Vomiting of Pregnancy). Current dosing is normally up to a maximum of 4 tablets daily regardless of patient weight.

Hypothesis

Mass-based dosing of Diclectin will be well tolerated, antihistaminic side effects may be more common than with standard Diclectin dosing. Mass-based dosing of Diclectin will be more effective for the treatment of NVP than standard dosing of Diclectin.

Objectives

To conduct an open label single arm treatment study of mass-based dosing of Diclectin for NVP, in order to determine the side effect profile and estimate the effectiveness of mass-based Diclectin dosing.

Methods

Patients who call Motherisk or the NVP Helpline at the Hospital for Sick Children (HSC), and are currently experiencing NVP despite 4 tablets per day of Diclectin, will be informed of the study and invited to come to the NVP Clinic at the HSC for further information about both the study and alternative approaches to treatment of NVP. Patients will be stratified into one of four weight categories and dosed accordingly.

Sample size

A total of 40 women will be recruited. At least five women will be recruited from each of the weight categories.

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