Pre-emptive Treatment of Severe Nausea and Vomiting of Pregnancy (NCT00293644) | Clinical Trial Compass
CompletedPhase 3
Pre-emptive Treatment of Severe Nausea and Vomiting of Pregnancy
Canada76 participantsStarted 2006-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of severe NVP (defined by PUQE score >12), or HG (defined by PUQE score >12 plus hospitalization), as compared among the 3 groups.
Timeframe: Follow-up in all groups will be continued monthly until delivery. An additional follow-up telephone interview will be done at approximately 6 months post delivery.