The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy

Inclusion Criteria:

• The patient has signed a written informed consent to participate in the study and hasagreed to follow dosing instructions and complete all required study visits.
• The patient is a pregnant female age equal to or greater than 18 years old.
• The patient's entry ultrasound indicates a viable pregnancy and confirms gestationalage of the fetus is 7-14 weeks at the anticipated time of the first dose of studymedication or placebo. If an ultrasound was done within 4 weeks of the admissionvisit, and results can be obtained, an additional ultrasound is not necessary.
• The patient is suffering from NVP and has a Pregnancy Unique Quantification of Emesis (PUQE) score ≥6.
• The patient has not responded to conservative management consisting ofdietary/lifestyle advice according to the 2004 ACOG Practice Bulletin.
• The patient agrees, if on a multivitamin, to continue on their current dose ofmultivitamin for the duration of the trial.
• The patient does not plan termination of the pregnancy.

Exclusion Criteria:

• The investigator confirms the patient's nausea and vomiting is of etiology other thanNausea and Vomiting of Pregnancy (NVP).
• The patient has gestational trophoblastic disease or multifetal gestation.
• The patient has a condition for which antihistamines, in the opinion of theinvestigator, are contraindicated (epilepsy, alcoholism, glaucoma, chronic lungdisease, urinary retention, heart block, etc.).
• The patient has used antihistamines, anticholinergics, dopamine antagonists, serotoninantagonists, ginger, or anti-emetic therapy (including acupressure, acupuncture,homeopathic remedies, medical hypnosis, relief bands etc) to treat NVP in the previous 48 hours or plans to do so during the study .
• The patient is using drugs that have anticholinergic activity (e.g., tricyclicantidepressants).
• The patient is taking multivitamins containing more than 10 mg of vitamin B6, or plansto do so during the study.
• The patient is taking supplementary vitamin B6 in addition to any multivitaminpreparation, or plans to do so during the study.
• The patient is currently drinking any amount of alcohol.
• The patient has any condition that might interfere with the conduct of the study.
• The patient is likely to be unable to comply with study procedures because ofinadequate cognitive skills.
• The patient has received an investigational drug within 30 days before enrollment inthis study or is scheduled to receive an investigational drug during the course ofthis study.