Condition category
Pregnancy and Childbirth
Date applied
14/02/2006
Date assigned
14/02/2006
Last edited
04/11/2008
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

Dr M R Douma

ORCID ID

Contact details

Bronovo Hospital
Department of Obstetrics and Gynaecology
Bronovolaan 5
The Hague
2597 AX
Netherlands
+31 (0)61 427 6591
maritdouma@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR543

Study information

Scientific title

Acronym

Baringspijn

Study hypothesis

The hypothesis of this study is that the new opioid remifentanil will provide less side-effects and better pain relief during labour, than the conventional opioids fentanyl and pethidine.

Ethics approval

Received from local medical ethics committee

Study design

Double-blind randomised active controlled parallel group clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Labour pain

Intervention

The following drugs are used in a patient controlled method:
1. Remifentanil - 40 µg for 2 minutes, total dosage: 1200 µg/h
2. Pethidine - loading dose of 50 mg, then 5 mg for 10 minutes, total dosage: 200 mg
3. Fentanyl - loading dose of 50 µg, then 20 µg for 5 minutes, total dosage: 240 µg/h

Medication will be started in active labour and will be continued until complete dilation of the cervix is achieved. Baseline non-invasive measurements will be made, including maternal blood pressure, heart rate, respiratory rate and pulse oximetry. Measurements will be recorded every 30 minutes. Also, an observer sedation score will be recorded every 30 minutes.

Intervention type

Drug

Phase

Not Specified

Drug names

Pethidine, remifentanil, fentanyl

Primary outcome measures

1. Quality of pain relief determined by Visual Analogue Scale, patient controlled analgesia (PCA) demands/rewards and the number of patients crossing over to epidural analgesia. Pain scores will be assessed every hour.
2. Patient satisfaction, assessed every hour
3. Foetal outcome as determined by Apgar, NACS and requirement for naloxone, taken after delivery
4. Presence of opioid substances in umbilical and maternal blood samples, taken after delivery

Secondary outcome measures

No secondary outcome measures

Overall trial start date

10/08/2005

Overall trial end date

01/09/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged at least 18 years old
2. Between 37 and 42 weeks of gestation
3. American Society of Anaesthesiologists (ASA) physical status I or II

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

240

Participant exclusion criteria

1. ASA physical status greater than or equal to III
2. Obesity (body mass index [BMI] equal or more than 40 kg/m^2)
3. Substance abuse history
4. High risk patients: including pre-eclampsia (diastolic pressure equal or more than 100, proteinuria), hepatic insufficiency or renal failure, severe asthma, poorly controlled diabetes mellitus
5. Premature labour
6. Drug allergy; history of hypersensitivity to opioid substances

Recruitment start date

10/08/2005

Recruitment end date

01/09/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Bronovo Hospital
The Hague
2597 AX
Netherlands

Sponsor information

Organisation

Bronovo Hospital (The Netherlands)

Sponsor details

Department of Obstetrics and Gynaecology
Bronovolaan 5
The Hague
2597 AX
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.bronovo.nl/Bronovo/en-GB/bronovo/

Funders

Funder type

Hospital/treatment centre

Funder name

Bronovo Hospital (The Netherlands) - research funds

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

Publication citations

Additional files

Editorial Notes