Hyperemesis GravidarumPhase 3NCT00861523
Does Thiamine Help Vomiting and Nausea in Pregnancy?
A Phase 3 study testing thiamine & promethazine in people with Hyperemesis Gravidarum, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
There are different treatments for nausea and vomiting in pregnancy. According to the ACOG recommendations, promethazine is the first line of parenteral treatment after oral treatment had failed. Thiamine is given to prevent wernicke encephalopathy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hyperemesis Gravidarum
- What is being tested?
- thiamine & promethazine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2009to Jan 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women until 12th week of gestation
- The women visit the ER because of nausea and vomiting
- The women didn't received thiamine yet
Who cannot join
- Pregnant women over 12th week of gestation
- Women that received thiamine before
- women that allergic to the studied drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between the Treatment of Thiamine and Promethazine for Improving Vomiting and Nausea in Pregnancy
There are different treatments for nausea and vomiting in pregnancy. According to the ACOG recommendations, promethazine is the first line of parenteral treatment after oral treatment had failed. Thiamine is given to prevent wernicke encephalopathy. This research try to find out whether thiamine helps the vomiting and nausea as well, by comparing the response to thiamine and promethazine in women who suffer from nausea and vomiting in pregnancy.
Read the detailed description
- Research groups: pregnant women eho visit the emergency room for nausea and vomiting in pregnancy, pregnancy age 12 weeks or less
- After basic examinations and hydration, the women will randomized to thiamine or promethazine treatment.
- If no improvement is shown, the patient will be treated with the other drug
- The patients will be interviewed on their current visit and every two weeks until 14th week of gestation
- The interview includes medical history and details about their illness, other treatments, hospitalization etc.
- Conditions
- Hyperemesis Gravidarum
- Being tested
- thiamine & promethazine
- Keywords
- nausea, vomiting, pregnancy, thiamine, promethazine, nausea and vomiting in pregnancy
- Medical subject headings
- Hyperemesis Gravidarum, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thiamine & promethazineDrug
thiamine 100 mg IV promethazine 25 mg IV
| Study group | Role | What they receive |
|---|---|---|
| 1. thiamine | Active comparator | Pregnant women until 12 week of gestation who refer to the ER because of nausea and vomiting and didn't improve after hydration, will receive thiamine IV Receives: Drug: thiamine & promethazine |
| 2. promethazine | Active comparator | Pregnant women until 12 week of gestation who refer to the ER because of nausea and vomiting and didn't improve after hydration, will receive promethazine IV Receives: Drug: thiamine & promethazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the improvement in nausea and/or vomiting after treatment
Measured: 2 months after first visit in ER (until 14 week of pregnancy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Difficulties in recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperemesis GravidarumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yfat Kadan, Principal investigator, haemek medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861523
- Sponsor's protocol ID
- 0101-08-EMC
- Status last verified
- Jun 2015
- First submitted
- 18 Feb 2009
- Last updated
- 23 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Treatment of Thiamine and Promethazine for Improving Vomiting and Nausea in Pregnancy
- ClinicalTrials.gov ID
- NCT00861523
- Acronym / sponsor ID
- 0101-08-EMC
- Conditions
- Hyperemesis Gravidarum
- Keywords
- nausea, vomiting, pregnancy, thiamine, promethazine, nausea and vomiting in pregnancy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in recruiting patients
- Enrolment
- 50 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 13 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are different treatments for nausea and vomiting in pregnancy. According to the ACOG recommendations, promethazine is the first line of parenteral treatment after oral treatment had failed. Thiamine is given to prevent wernicke encephalopathy. This research try to find out whether thiamine helps the vomiting and nausea as well, by comparing the response to thiamine and promethazine in women who suffer from nausea and vomiting in pregnancy.
Detailed description
- Research groups: pregnant women eho visit the emergency room for nausea and vomiting in pregnancy, pregnancy age 12 weeks or less
- After basic examinations and hydration, the women will randomized to thiamine or promethazine treatment.
- If no improvement is shown, the patient will be treated with the other drug
- The patients will be interviewed on their current visit and every two weeks until 14th week of gestation
- The interview includes medical history and details about their illness, other treatments, hospitalization etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. thiamine | Active comparator | Drug: thiamine & promethazinePregnant women until 12 week of gestation who refer to the ER because of nausea and vomiting and didn't improve after hydration, will receive thiamine IV |
| 2. promethazine | Active comparator | Drug: thiamine & promethazinePregnant women until 12 week of gestation who refer to the ER because of nausea and vomiting and didn't improve after hydration, will receive promethazine IV |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women until 12th week of gestation
- The women visit the ER because of nausea and vomiting
- The women didn't received thiamine yet
Key exclusion criteria (3 listed)
- Pregnant women over 12th week of gestation
- Women that received thiamine before
- women that allergic to the studied drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thiamine & promethazinethiamine 100 mg IV promethazine 25 mg IV | Drug | 1. thiamine, 2. promethazine |
Primary outcome
the improvement in nausea and/or vomiting after treatment
Time frame: 2 months after first visit in ER (until 14 week of pregnancy)
Results and safety
The study was stopped early (reason given: Difficulties in recruiting patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yfat Kadan principal investigator
haemek medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing thiamine & promethazine in people with Hyperemesis Gravidarum, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulties in recruiting patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the improvement in nausea and/or vomiting after treatment (time frame: 2 months after first visit in ER (until 14 week of pregnancy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2015.