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Acupressure in Hyperemesis Gravidarum

Sponsor
Universiti Kebangsaan Malaysia Medical Centre (Other)
Overall Status
Completed
CT.gov ID
NCT05175079
Collaborator
(none)
90
Enrollment
1
Location
2
Arms
11
Actual Duration (Months)
8.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Acupressure band
  • Other: Standard treatment hospital protocol
 N/A

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

Study Type:
Interventional
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 :
Oct 1, 2016
Actual Primary Completion Date :
Aug 31, 2017
Actual Study Completion Date :
Aug 31, 2017

Arms and Interventions

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

Primary Outcome Measures

  1. Degree of nausea and vomiting [day 1 to day 3]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Universiti Kebangsaan Malaysia Medical Centre Kuala Lumpur Malaysia 56000

Sponsors and Collaborators

  • Universiti Kebangsaan Malaysia Medical Centre

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universiti Kebangsaan Malaysia Medical Centre
ClinicalTrials.gov Identifier:
NCT05175079
Other Study ID Numbers:
  • FF-2017-195
First Posted:
Jan 3, 2022
Last Update Posted:
Jan 3, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hyperemesis Gravidarum

Study Results

No Results Posted as of Jan 3, 2022