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Acupressure in Hyperemesis Gravidarum

Primary Purpose

Hyperemesis Gravidarum

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Acupressure band
Standard treatment hospital protocol
Sponsored by
Universiti Kebangsaan Malaysia Medical Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperemesis Gravidarum

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Universiti Kebangsaan Malaysia Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Accupressure group

Control group

Arm Description

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

Outcomes

Primary Outcome Measures

Degree of nausea and vomiting
measure the effect of acupressure using modified Pregnancy Unique Quantification of Emesis and Nausea (PUQE)

Secondary Outcome Measures

Full Information

First Posted
December 13, 2021
Last Updated
December 30, 2021
Sponsor
Universiti Kebangsaan Malaysia Medical Centre
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1. Study Identification

Unique Protocol Identification Number
NCT05175079
Brief Title
Acupressure in Hyperemesis Gravidarum
Official Title
A Randomised Controlled Trial On Effect Of Acupressure On Nausea And Vomiting In Women With Hyperemesis Gravidarum
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
August 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universiti Kebangsaan Malaysia Medical Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperemesis Gravidarum

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Accupressure group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Acupressure band
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Standard treatment hospital protocol
Intervention Description
Intravenous metaclopromide 10mg PRN Intravenous fluids as per protocol
Primary Outcome Measure Information:
Title
Degree of nausea and vomiting
Description
measure the effect of acupressure using modified Pregnancy Unique Quantification of Emesis and Nausea (PUQE)
Time Frame
day 1 to day 3

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Universiti Kebangsaan Malaysia Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No data are available for sharing
Citations:
PubMed Identifier
36078602
Citation
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.
Results Reference
derived

Learn more about this trial

Acupressure in Hyperemesis Gravidarum

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