Status:
COMPLETED
Pre-emptive Treatment of Severe Nausea and Vomiting of Pregnancy
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
Duchesnay Inc.
Conditions:
Hyperemesis Gravidarum
Pregnancy
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 Nau...
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 gravid...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00293644
Start Date
February 1 2006
End Date
June 1 2015
Last Update
July 22 2016
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8