NCT05175079

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 3, 2022

Completed
Last Updated

January 3, 2022

Status Verified

December 1, 2021

Enrollment Period

11 months

First QC Date

December 13, 2021

Last Update Submit

December 30, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Accupressure group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR
Other: Standard treatment hospital protocol

Interventions

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

Accupressure group

Intravenous metaclopromide 10mg PRN Intravenous fluids as per protocol

Control group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiti Kebangsaan Malaysia Medical Centre

Kuala Lumpur, 56000, Malaysia

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hyperemesis Gravidarum

Condition Hierarchy (Ancestors)

Morning SicknessPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVomitingSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2021

First Posted

January 3, 2022

Study Start

October 1, 2016

Primary Completion

August 31, 2017

Study Completion

August 31, 2017

Last Updated

January 3, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

No data are available for sharing

Locations