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Register:	ISRCTN
Last refreshed on:	1 June 2020
Main ID:	ISRCTN80694386
Date of registration:	16/03/2016
Prospective Registration:	Yes
Primary sponsor:	University of Malaya (Malaysia)
Public title:	Delayed compared with early feeding in the initial hospital management of hyperemesis gravidarum
Scientific title:	Delayed compared with early oral intake in the initial manangement of hyperemesis gravidarum: a randomised trial
Date of first enrolment:	01/04/2016
Target sample size:	160
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN80694386
Study type:	Interventional
Study design:	Two-arm clinical trial (Treatment)
Phase:	Not Applicable

Countries of recruitment
Malaysia

Contacts

Name:	Peng Chiong Tan
Address:	Department of Obstetrics and Gynaecology Faculty of Medicine University of Malaya Lembah Pantai 50603 Kuala Lumpur Malaysia
Telephone:	+60 (0)123 052 970
Email:	pctan@um.edu.my
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
1. Clinical diagnosis of hyperemesis gravidarum
2. First hospitalisation for hyperemesis gravidarum in current pregnancy
3. Presence of ketonuria by urine dipstick (of 2+ or greater) at hospitalisation
4. At least 18 years of age
5. Pregnancy gestation of 14 weeks or less

Exclusion criteria:
1. Multiple pregnancy
2. Molar pregnancy
3. Confirmed non-viable pregnancy
4. Any medical condition that contraindicates oral feeding or fasting

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Hyperemesis gravidarum
Pregnancy and Childbirth

Intervention(s)

Participants are randomized to:
1. Delayed oral intake (fasting) for the first 12 hours after hospitalisation for hyperemesis gravidarum followed by resumption of taking fluids and solids orally at the participants own pace
2. Encouraged to take fluids and solids orally as soon as, as much as and as often as tolerated after hospitalisation for hyperemesis gravidarum

Both arms are to receive intravenous rehydration, oral thiamine supplementation and intravenous anti-emetic as standard inpatient treatment for hyperemesis gravidarum

Primary Outcome(s)

1. Frequency of vomiting in the first 24 hours
2. Nausea score (using a Visual Numerical Rating Scale from 0 to 10) at enrollment, 8, 16 and 24 hours
3. Patient’s satisfaction score (using a Visual Numerical Rating Scale from 0 to 10) at 24 hours

Secondary Outcome(s)

1. Duration of hospitalisation
2. Ketonuria at 24 hours
3. An 8-item symptoms questionnaire at 24 hours
4. Participant preference on feeding regimen in a future hospitalisation for hyperemesis gravidarum at 24 hours
5. Participant recommendation of their feeding regimen to a friend in the same circumstances at 24 hours

Secondary ID(s)

1206.12

Source(s) of Monetary Support

Universiti Malaya

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

University Malaya Medical Centre Medical Ethics Committee, 04/02/2016, approval no. 1206.12

Results

Results available:	Yes
Date Posted:
Date Completed:	30/09/2017
URL:

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