Nausea GravidarumNCT05370170
Ottawa Nutritional Guidelines for Nausea and Vomiting
A study testing Acupressure and nutritional advices in people with Nausea Gravidarum, run by Cairo University at 1 site in Egypt.
Trial summary
Effect of Implementing Ottawa Nutritional Guidelines on the Course of Nausea and Vomiting During Pregnancy (A Randomized Control Trial) Read more about this study
- Who is it for?
- Ages 22 to 35 years, women only
- Conditions the study is for
- Nausea Gravidarum
- What is being tested?
- Acupressure and nutritional advices
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 30 Sep 2021
- Phase
- Interventional
- 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 22 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- primigravida
- gestational age of 7-13 weeks
- singleton pregnancy
- having a score of 7-12 on the (PUQE 24)
- can read and write
- having phone number
- not receiving medications for reducing NVP, except for vitamin B6
- wanted pregnancy.
Who cannot join
- subject's unwillingness to continue the study
- occurrence of obstetric complications during the study
- hyper-emesis gravidarum
- having physical or mental disorders
- having oral/speech impairments
- having assisted reproductive techniques for the present pregnancy
Show all 10Show fewer
- having two consecutive miscarriages before the current pregnancy
- old primigravida
- narcotic use or alcohol drinking
- and subjects who will show signs and symptoms of hyperemesis gravidarum during the study will be dropped out and referred to medical care.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Implementing Ottawa Nutritional Guidelines on the Course of Nausea and Vomiting During Pregnancy (A Randomized Control Trial)
Effect of Implementing Ottawa Nutritional Guidelines on the Course of Nausea and Vomiting During Pregnancy (A Randomized Control Trial)
Read the detailed description
Studying the Effect of Implementing Ottawa Nutritional Guidelines on the Course of Nausea and Vomiting During Pregnancy (A Randomized Control Trial) using no pharmacological agents and life style modification in addition to acupressure to treat nausea and vomiting of pregnancy
- Conditions
- Nausea Gravidarum
- Being tested
- Acupressure and nutritional advices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupressure and nutritional advicesBehavioural
Teaching using booklets and application of acupressure
| Study group | Role | What they receive |
|---|---|---|
| Routine antenatal care | No intervention | the control group will receive routine antenatal care and will not receive the guidelines group included 30 cases |
| Ottawa guidelines | Experimental | study group will receive routine antenatal care in addition to the Ottawa nutritional guidelines group included 30 cases Receives: Behavioral: Acupressure and nutritional advices |
What is being measured
The primary outcome is the main question the study is designed to answer.
control nausea and vomiting
control the frequency and severity of nausea and vomiting and measure it by using Pregnancy Unique Quantification of Emesis
Measured: 3 weeks
Secondary outcomes (1)
maintain normal body weight and prevent hospitalization
Monitor mother weight by calipered weight scale to monitor weight loss related to nausea and vomiting
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start1 Jan 2021
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea GravidarumStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noura Mohamed Eltoukhy, Cairo University
- Investigators
- Noura Mo Eltoukhi, PhD, Principal investigator, Cairo UniversityNoura M Eltoukhi, lecturer, Principal investigator, Faculty of Nursing Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370170
- Sponsor's protocol ID
- IORG0003381
- Status last verified
- Jun 2025
- First submitted
- 30 Mar 2022
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with researchers upon reasonable request following publication of the main results."
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Implementing Ottawa Nutritional Guidelines on the Course of Nausea and Vomiting During Pregnancy (A Randomized Control Trial)
- ClinicalTrials.gov ID
- NCT05370170
- Acronym / sponsor ID
- IORG0003381
- Conditions
- Nausea Gravidarum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 11 May 2022 (actual)
- 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.
Effect of Implementing Ottawa Nutritional Guidelines on the Course of Nausea and Vomiting During Pregnancy (A Randomized Control Trial)
Detailed description
Studying the Effect of Implementing Ottawa Nutritional Guidelines on the Course of Nausea and Vomiting During Pregnancy (A Randomized Control Trial) using no pharmacological agents and life style modification in addition to acupressure to treat nausea and vomiting of pregnancy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine antenatal care | No intervention | –the control group will receive routine antenatal care and will not receive the guidelines group included 30 cases |
| Ottawa guidelines | Experimental | Behavioral: Acupressure and nutritional advicesstudy group will receive routine antenatal care in addition to the Ottawa nutritional guidelines group included 30 cases |
Who may qualify
- Ages
- 22 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- primigravida
- gestational age of 7-13 weeks
- singleton pregnancy
- having a score of 7-12 on the (PUQE 24)
- can read and write
Key exclusion criteria (10 listed)
- subject's unwillingness to continue the study
- occurrence of obstetric complications during the study
- hyper-emesis gravidarum
- having physical or mental disorders
- having oral/speech impairments
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 |
|---|---|---|
| Acupressure and nutritional advicesTeaching using booklets and application of acupressure | Behavioural | Ottawa guidelines |
Primary outcome
control nausea and vomiting
Time frame: 3 weeks
control the frequency and severity of nausea and vomiting and measure it by using Pregnancy Unique Quantification of Emesis
1 secondary outcome
maintain normal body weight and prevent hospitalization
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: Yes. Data will be shared with researchers upon reasonable request following publication of the main results."
Related trials for Nausea Gravidarum
Not yet recruitingObservational study
Diagnostic and Psychometric Validation of the FRENCH HELP Scale in Hyperemesis Gravidarum
Hyperemesis Gravidarum, Nausea and Vomiting of Pregnancy
RecruitingPhase 1/2
Hyperemesis Gravidarum Risk Reduction With Metformin
Hyperemesis Gravidarum
Not yet recruiting
Tablet Ginger Versus Tablet Doxylamine Succinate in Control of Nausea and Vomiting in Pregnancy
Nausea Gravidarum, Hyperemesis Gravidarum
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.
Noura Mo Eltoukhi, PhD principal investigator
Cairo University
Noura M Eltoukhi, lecturer principal investigator
Faculty of Nursing Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure and nutritional advices in people with Nausea Gravidarum, run by Cairo University at 1 site in Egypt.
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 8 inclusion and 10 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: finished, as of the sponsor's last update on 11 Jun 2025. 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 Egypt. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
control nausea and vomiting (time frame: 3 weeks). 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 11 Jun 2025.