Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acupressure in Hyperemesis Gravidarum

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05175079
Recruitment Status : Completed
First Posted : January 3, 2022
Last Update Posted : January 3, 2022
Sponsor:
Information provided by (Responsible Party):
Universiti Kebangsaan Malaysia Medical Centre

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
To examine the degree of nausea, vomiting between the acupressure and control group in women with hyperemesis gravidarum

Condition or disease Intervention/treatment Phase
Hyperemesis Gravidarum Device: Acupressure band Other: Standard treatment hospital protocol Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomised Controlled Trial On Effect Of Acupressure On Nausea And Vomiting In Women With Hyperemesis Gravidarum
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Accupressure group

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

 Device: Acupressure band

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
Placebo Comparator: Control group Other: Standard treatment hospital protocol
Intravenous metaclopromide 10mg PRN Intravenous fluids as per protocol


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant women
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Onset of vomiting before 16 weeks
  2. Vomiting at least 2 times per day
  3. Ketonuria on admission
  4. Mid stream urine specimen that did not indicate infection

Exclusion Criteria:

  1. Non viable pregnancy
  2. Molar pregnancy
  3. Overt clinical features of thyrotoxicosis
  4. Known case of medical illness that associated with nausea and vomiting
  5. Patient refusal or patients who are not able to give consent
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05175079


Locations
Layout table for location information
Malaysia
Universiti Kebangsaan Malaysia Medical Centre
Kuala Lumpur, Malaysia, 56000
Sponsors and Collaborators
Universiti Kebangsaan Malaysia Medical Centre
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Universiti Kebangsaan Malaysia Medical Centre
ClinicalTrials.gov Identifier: NCT05175079    
Other Study ID Numbers: FF-2017-195
First Posted: January 3, 2022    Key Record Dates
Last Update Posted: January 3, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No data are available for sharing

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperemesis Gravidarum
Morning Sickness
Pregnancy Complications
Vomiting
Signs and Symptoms, Digestive