Acupressure in Hyperemesis Gravidarum

NCT ID: NCT05175079

Last Updated: 2022-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2017-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hyperemesis Gravidarum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Acupressure band

Intervention Type DEVICE

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

Control group

Group Type PLACEBO_COMPARATOR

Standard treatment hospital protocol

Intervention Type OTHER

Intravenous metaclopromide 10mg PRN Intravenous fluids as per protocol

Interventions

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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

Intervention Type DEVICE

Standard treatment hospital protocol

Intravenous metaclopromide 10mg PRN Intravenous fluids as per protocol

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universiti Kebangsaan Malaysia Medical Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universiti Kebangsaan Malaysia Medical Centre

Kuala Lumpur, , Malaysia

Site Status

Countries

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Malaysia

References

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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.

Reference Type DERIVED
PMID: 36078602 (View on PubMed)

Other Identifiers

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FF-2017-195

Identifier Type: -

Identifier Source: org_study_id

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