Hyperemesis in Pregnancy study

ISRCTN	ISRCTN56847191
DOI	https://doi.org/10.1186/ISRCTN56847191
Secondary identifying numbers	N/A

Submission date: 30/05/2006
Registration date: 11/07/2006
Last edited: 28/10/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof S.C. Robson
Scientific

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

Study information

Study design	Randomised controlled trial, participants allocated via a University web-based randomisation service
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Hyperemesis in Pregnancy study
Study acronym	HiPs
Study objectives	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(s)	Newcastle and North Tyneside Local Research Ethics Committees, 25/02/2004, Ref: 2003/207
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Cyclizine lactate, ringer lactate solution
Primary outcome measure	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 study start date	01/03/2004
Completion date	31/12/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	50
Key inclusion criteria	Any woman attending the maternity assessment unit under 20 weeks gestation suffering from moderate or severe nausea and vomiting
Key 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
Date of first enrolment	01/03/2004
Date of final enrolment	31/12/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

School of Surgery and Reproductive Sciences

Newcastle upon Tyne
NE1 7RU
United Kingdom

Sponsor information

Newcastle upon Tyne Hospitals NHS Trust (UK)
Hospital/treatment centre

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

"ROR"	https://ror.org/05p40t847

Funders

Funder type

Hospital/treatment centre

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

No information available

Consumables supplied by the hospital.

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2016		Yes	No

Editorial Notes

28/10/2016: Publication reference added