Condition category
Pregnancy and Childbirth
Date applied
30/05/2006
Date assigned
11/07/2006
Last edited
28/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof S.C. Robson

ORCID ID

Contact details

School of Surgery and Reproductive Sciences
3rd Floor
William Leech Building
Medical School University of Newcastle
Framlington Place
Newcastle upon Tyne
NE1 7RU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Hyperemesis in Pregnancy study

Acronym

HiPs

Study hypothesis

Nausea and vomiting in pregnancy (NVP) is a frequently occurring, often debilitating condition. The impact on the mother's quality of life can be substantial. Management of NVP remains controversial and inconsistent. Out-patient rapid re-hydration may reduce the need for recurrent admission.

Our hypothesis is that outpatient management with rapid re-hydration in mothers referred to hospital with NVP does not increase readmission rate as compared to mothers receiving conventional inpatient management.

Ethics approval

Newcastle and North Tyneside Local Research Ethics Committees, 25/02/2004, Ref: 2003/207

Study design

Randomised controlled trial, participants allocated via a University web-based randomisation service

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Hyperemesis gravidarum / severe nausea and vomiting in pregnancy

Intervention

On admission, all women will be offered an anti-emetic injection (cyclizine lactate, 50 mg), and given an advice leaflet detailing helpful measures to reduce symptoms. They will be given a study information sheet and if they consent to participate they will be randomised using a web-based electronic system into one of two arms. All women will be asked to complete an initial questionnaire and a seven day self-completion questionnaire.

Intervention: women will remain in the assessment unit. After establishment of intravenous access and measurement of electrolytes, they will receive three litres of intravenous ringer lactate solution infused over six hours. During this time they will be given a leaflet explaining about NVP and self-help information to try and reduce recurrence of symptoms. After hydration women will be discharged on a seven day course of oral anti-emetics, (cyclizine lactate 50 mg) with clear instructions about contacting the assessment unit if symptoms recur or deteriorate. Women are then telephoned by a specialist midwife on day three and day seven to assess symptoms and provide support. Should a woman experience deterioration in symptoms, despite self-help and support, one further attempt at symptom control with rapid hydration and anti-emetics will be offered within seven days of the first admission.

Control: women will be admitted to the antenatal ward and managed according to current guidelines which includes intravenous therapy as prescribed. At discharge women will be given a seven day supply of oral anti-emetics and will receive a telephone call from the research midwife to encourage return of the self completion questionnaire.

Intervention type

Drug

Phase

Not Specified

Drug names

Cyclizine lactate, ringer lactate solution

Primary outcome measures

Whether rapid rehydration administered over six hours in a day care setting, combined with out-patient psychological support reduces in-patient stay and improves women's quality of life.

Secondary outcome measures

The cost consequences of rapid rehydration on an out-patient basis compared to the current policy of routine admission.

Overall trial start date

01/03/2004

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Any woman attending the maternity assessment unit under 20 weeks gestation suffering from moderate or severe nausea and vomiting

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

50

Participant exclusion criteria

1. Poor/no English
2. Over 20 weeks gestation
3. Under 16 year old or over 45 years
4. No treatment warranted
5. Women with significant medical conditions, e.g., insulin-dependent diabetes mellitus (IDDM), renal disease, cardiac disease
6. Women not suitable for out-patient management
7. Three admissions or more in the same week

Recruitment start date

01/03/2004

Recruitment end date

31/12/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Surgery and Reproductive Sciences
Newcastle upon Tyne
NE1 7RU
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Trust (UK)

Sponsor details

Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

WTE research midwife, jointly funded by the hospital Trust and the University of Newcastle.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Consumables supplied by the hospital.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/26963896

Publication citations

Additional files

Editorial Notes

28/10/2016: Publication reference added