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NCT05175079 Clinical Trial

Acupressure in Hyperemesis Gravidarum

Hyperemesis Gravidarum Clinical Trial

Official title:
A Randomised Controlled Trial On Effect Of Acupressure On Nausea And Vomiting In Women With Hyperemesis Gravidarum

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05175079
Other study ID # FF-2017-195
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2016
Est. completion date August 31, 2017

Study information
Verified date December 2021
Source Universiti Kebangsaan Malaysia Medical Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To examine the degree of nausea, vomiting between the acupressure and control group in women with hyperemesis gravidarum

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.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date August 31, 2017
Est. primary completion date August 31, 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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
Other:
• Standard treatment hospital protocol
Intravenous metaclopromide 10mg PRN Intravenous fluids as per protocol

Locations
Country Name City State
Malaysia Universiti Kebangsaan Malaysia Medical Centre Kuala Lumpur

Sponsors (1)
Lead Sponsor Collaborator
Universiti Kebangsaan Malaysia Medical Centre

Country where clinical trial is conducted

Malaysia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Degree of nausea and vomiting measure the effect of acupressure using modified Pregnancy Unique Quantification of Emesis and Nausea (PUQE) day 1 to day 3
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