Hyperemesis GravidarumNCT05175079
Acupressure in Hyperemesis Gravidarum
A study testing Acupressure band and Standard treatment hospital protocol in people with Hyperemesis Gravidarum, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
Trial summary
To examine the degree of nausea, vomiting between the acupressure and control group in women with hyperemesis gravidarum Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Hyperemesis Gravidarum
- What is being tested?
- Acupressure band and Standard treatment hospital protocol
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Oct 2016to 31 Aug 2017
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Onset of vomiting before 16 weeks
- Vomiting at least 2 times per day
- Ketonuria on admission
- Mid stream urine specimen that did not indicate infection
Who cannot join
- Non viable pregnancy
- Molar pregnancy
- Overt clinical features of thyrotoxicosis
- Known case of medical illness that associated with nausea and vomiting
- Patient refusal or patients who are not able to give consent
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Universiti Kebangsaan Malaysia Medical Centre
Kuala Lumpur, 56000
About this study
Official title: A Randomised Controlled Trial On Effect Of Acupressure On Nausea And Vomiting In Women With Hyperemesis Gravidarum
To examine the degree of nausea, vomiting between the acupressure and control group in women with hyperemesis gravidarum
Read the detailed description
A prospective RCT conducted at Department of Obst and Gynae, UKMMC. All pregnant women with a normal intrauterine pregnancy of ≤ 16 week gestation with hyperemesis gravidarum will be assessed by the medical officer/ specialist/ consultant in charge. Explanation regarding the research study will be given for patients who fulfill the inclusion and exclusion criteria. Patients who have understood the research study and consented will be recruited as subjects for the study.
- Conditions
- Hyperemesis Gravidarum
- Being tested
- Acupressure band, Standard treatment hospital protocol
- Medical subject headings
- Hyperemesis Gravidarum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupressure bandDevice
acupressure band apply to P6 (nei guan) point which located three fingers below the skin wrinkles of the anterior wrist.
Acupressure band wear 3 times daily before breakfast, lunch and dinner for at least 10 minutes
Standard treatment hospital protocolOther
Intravenous metaclopromide 10mg PRN Intravenous fluids as per protocol
| Study group | Role | What they receive |
|---|---|---|
| Accupressure group | Experimental | acupressure band apply to P6 (nei guan) point which located three fingers below the skin wrinkles of the anterior wrist.
Acupressure band wear 3 times daily before breakfast, lunch and dinner for at least 10 minutes Receives: Device: Acupressure band |
| Control group | Placebo comparator | Not described Receives: Other: Standard treatment hospital protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of nausea and vomiting
measure the effect of acupressure using modified Pregnancy Unique Quantification of Emesis and Nausea (PUQE)
Measured: day 1 to day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start1 Oct 2016
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175079
- Sponsor's protocol ID
- FF-2017-195
- Status last verified
- Dec 2021
- First submitted
- 13 Dec 2021
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data are available for sharing
Publications
Mohd Nafiah NA, Chieng WK, Zainuddin AA, Chew KT, Kalok A, Abu MA, Ng BK, Mohamed Ismail NA, Nur Azurah AG. Effect of Acupressure at P6 on Nausea and Vomiting in Women with Hyperemesis Gravidarum: A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Sep 1;19(17):10886. doi: 10.3390/ijerph191710886.
PubMed 36078602
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial On Effect Of Acupressure On Nausea And Vomiting In Women With Hyperemesis Gravidarum
- ClinicalTrials.gov ID
- NCT05175079
- Acronym / sponsor ID
- FF-2017-195
- Conditions
- Hyperemesis Gravidarum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical CentreUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 3 Jan 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.
To examine the degree of nausea, vomiting between the acupressure and control group in women with hyperemesis gravidarum
Detailed description
A prospective RCT conducted at Department of Obst and Gynae, UKMMC. All pregnant women with a normal intrauterine pregnancy of ≤ 16 week gestation with hyperemesis gravidarum will be assessed by the medical officer/ specialist/ consultant in charge. Explanation regarding the research study will be given for patients who fulfill the inclusion and exclusion criteria. Patients who have understood the research study and consented will be recruited as subjects for the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accupressure group | Experimental | Device: Acupressure bandacupressure band apply to P6 (nei guan) point which located three fingers below the skin wrinkles of the anterior wrist. Acupressure band wear 3 times daily before breakfast, lunch and dinner for at least 10 minutes |
| Control group | Placebo comparator | Other: Standard treatment hospital protocol |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Onset of vomiting before 16 weeks
- Vomiting at least 2 times per day
- Ketonuria on admission
- Mid stream urine specimen that did not indicate infection
Key exclusion criteria (5 listed)
- Non viable pregnancy
- Molar pregnancy
- Overt clinical features of thyrotoxicosis
- Known case of medical illness that associated with nausea and vomiting
- Patient refusal or patients who are not able to give consent
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 bandacupressure band apply to P6 (nei guan) point which located three fingers below the skin wrinkles of the anterior wrist. Acupressure band wear 3 times daily before breakfast, lunch and dinner for at least 10 minutes | Device | Accupressure group |
| Standard treatment hospital protocolIntravenous metaclopromide 10mg PRN Intravenous fluids as per protocol | Other | Control group |
Primary outcome
Degree of nausea and vomiting
Time frame: day 1 to day 3
measure the effect of acupressure using modified Pregnancy Unique Quantification of Emesis and Nausea (PUQE)
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 3 Jan 2022.
- Derived from this study: PubMed 36078602Mohd Nafiah NA, Chieng WK, Zainuddin AA, Chew KT, Kalok A, Abu MA, Ng BK, Mohamed Ismail NA, Nur Azurah AG. Effect of Acupressure at P6 on Nausea and Vomiting in Women with Hyperemesis Gravidarum: A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Sep 1;19(17):10886. doi: 10.3390/ijerph191710886.
- Individual participant dataSharing planned: No. No data are available for sharing
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Hyperemesis Gravidarum Risk Reduction With Metformin
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 band and Standard treatment hospital protocol in people with Hyperemesis Gravidarum, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
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 4 inclusion and 5 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 3 Jan 2022. 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 Malaysia. 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. Some participants in this study may receive a placebo. 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?
Degree of nausea and vomiting (time frame: day 1 to day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05175079, which also lists 1 linked publication.
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 3 Jan 2022.