Pre-emptive Treatment of Severe Nausea and Vomiting of Pregnancy

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children
• Collaborator: Duchesnay Inc.
• Treatments: Dicyclomine; Dicyclomine, doxylamine, pyridoxine drug combination; Doxylamine; Pyridoxine

Criteria

Inclusion Criteria:

• Pregnancy of less than 9 weeks gestation with no symptoms of NVP

• Not pregnant

• Include all women with severe NVP/HG in a previous pregnancy regardless of outcome

• Severe NVP/HG in a previous pregnancy verbally confirmed by the initial recruitment intake questionnaire or previous pregnancy history of NVP/HG section (duration, severity, treatments, and hospitalisation)

• Verbally agree to participate in the study and send back rhe informed consent form

• Sufficient French or English language skills to understand the questionnaire and assessment material

• Women who agree to take Diclectin®

• Women can enrol with a consecutive pregnancy, if the study is still ongoing

Exclusion Criteria:

• Women who refuse to participate in the study or to send back the signed consent form

• Women with insufficient French or English language skills to understand the questionnaire and assessment material

• Women their first pregnancy and those who havn't suffered severe NVP/HG in previous pregnancy

• Gestational age beyond 9w+0d weeks of pregnancy

• Pregnant women who already suffer symptoms of NVP

• Pregnant women with known hypersensitivities to Diclectin®

• Women who do not agree to take Diclectin®

• Women who suffer symptoms of pyelonephritis, thyrotoxicosis, gestational trophoblastic neoplasia

• Pregnant women less than 18 years of age