Acupressure in Hyperemesis Gravidarum

December 30, 2021 updated by: Universiti Kebangsaan Malaysia Medical Centre

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia, 56000
        • Universiti Kebangsaan Malaysia Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
Other: Standard treatment hospital protocol
Intravenous metaclopromide 10mg PRN Intravenous fluids as per protocol
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
day 1 to day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Kebangsaan Malaysia Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

August 31, 2017

Study Completion (Actual)

August 31, 2017

Study Registration Dates

First Submitted

December 13, 2021

First Submitted That Met QC Criteria

December 30, 2021

First Posted (Actual)

January 3, 2022

Study Record Updates

Last Update Posted (Actual)

January 3, 2022

Last Update Submitted That Met QC Criteria

December 30, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FF-2017-195

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No data are available for sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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