Condition category
Pregnancy and Childbirth
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
17/04/2014
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

Miss Dawn Jackson

ORCID ID

Contact details

Poole Hospital NHS Foundation Trust
St Mary's Maternity Hospital
Poole
BH15 2JB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

6895

Study information

Scientific title

A two centre randomised controlled trial comparing intramuscular diamorphine and intramuscular pethidine for labour analgesia

Acronym

IDvIP

Study hypothesis

Study objectives:
To evaluate the maternal and neonatal efficacy and safety of intramuscular diamorphine 7.5 mg versus intramuscular pethidine 150 mg for labour pain.

Evaluation of study:
An intention to treat analysis will be used. Results will be presented with 95% confidence intervals whenever possible and will be reported using CONSORT guidelines.

Duration of study period: 3 years

Ethics approval

Southampton and SW Hampshire REC (B) approved on the 2nd March 2007 (ref: 07/Q1704/6)

Study design

Multicentre randomised process of care cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Reproductive Health and Childb, Generic Health Relevance and Cross Cutting Themes, Primary Care Research Network for England; Subtopic: Not Assigned, Reproductive Health and Childb (all Subtopics), Generic Health Relevance (all Subtopics); Disease:

Intervention

Study Medicinal Products: 7.5 mg diamorphine and 150 mg pethidine up to a maximum of two doses with a minimal interval of 2 hours between doses. Total duration of treatment and follow-up will be the duration of the women’s labour plus 24 hours after birth.

As of 10/01/2011 this record was updated to include an extended anticipated end date; the initial anticipated end date was 01/05/2010.

Intervention type

Drug

Phase

Phase IV

Drug names

Pethidine, diamorphine

Primary outcome measures

1. Change in pain intensity over 3 hours (AUC)
2. Side effects:
2.1. Need for neonatal resuscitation
2.2. Apgar score less than 7 at 1 minute

Secondary outcome measures

1. Pain relief
2. Maternal sedation
3. Nausea and vomiting
4. CTG
5. Patient satisfaction
6. % choosing analgesia for next pregnancy
7. Meconium staining
8. UApH
9. UVpH
10. Apgar scores
11. Naloxone
12. Neonatal SpO2
13. Feeding behaviour

Overall trial start date

01/11/2008

Overall trial end date

01/02/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Active labour with a singleton pregnancy
2. Regular uterine contractions of at least two in 10 minutes
3. Cervical dilatation of at least 3 cm
4. Foetal gestational age of 37 - 42 weeks
5. Minimum weight of 60 kg
6. Multiparous and nulliparous women
7. Spontaneously gone into labour or have had an amniotomy and intravenous oxytocin to induce labour
8. Aged 18 years and over

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned sample size: 450

Participant exclusion criteria

1. Allergy or previous severe reaction to opioid analgesia
2. Opioid dependency
3. History of foetal compromise
4. Maternal cardiorespiratory compromise
5. American Society of Anaesthesiologists (ASA) grade 3 and 4
6. Maternal weight greater than 120 kg

Recruitment start date

01/11/2008

Recruitment end date

01/02/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Poole Hospital NHS Foundation Trust
Poole
BH15 2JB
United Kingdom

Sponsor information

Organisation

Poole Hospital NHS Foundation Trust (UK)

Sponsor details

St Mary's Maternity Hospital
Longfleet Road
Poole
BH15 2JB
United Kingdom

Sponsor type

Government

Website

http://www.poole.nhs.uk

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme

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

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21740578
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24289216

Publication citations

  1. Protocol

    Wee MY, Tuckey JP, Thomas P, Burnard S, The IDvIP trial: a two-centre randomised double-blind controlled trial comparing intramuscular diamorphine and intramuscular pethidine for labour analgesia., BMC Pregnancy Childbirth, 2011, 11, 51, doi: 10.1186/1471-2393-11-51.

  2. Results

    Wee MY, Tuckey JP, Thomas PW, Burnard S, A comparison of intramuscular diamorphine and intramuscular pethidine for labour analgesia: a two-centre randomised blinded controlled trial., BJOG, 2014, 121, 4, 447-456, doi: 10.1111/1471-0528.12532.

Additional files

Editorial Notes