Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT02179294
Eligibility Criteria:
Inclusion Criteria:
Women who are admitted to labour ward who fulfil all the following criteria will be eligible to be randomised:
* Requesting systemic opioid analgesia
* 16 years of age or older
* Beyond 37 weeks gestation
* In established labour, defined as regular painful contractions, irrespective of cervical dilatation, with vaginal birth intended
* Able to understand all information (written and oral) presented (using an interpreter if necessary)
* Not participating in any other clinical trial of a medicinal product
* Live, singleton pregnancy with cephalic presentation
Exclusion Criteria:
* Contraindication to epidural analgesia
* Contraindication to intramuscular injection
* History of a previous adverse reaction to pethidine or remifentanil
* Patients taking long term opioid therapy including Methadone
* Systemic pain relief opioid in the last 4 hours administered by intravenous or intramuscular injection. (Oral medications comprising opioids alone or in combination preparations, administered in this 4 hour period, are permitted).
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
16 Years
Study:
NCT02179294
Study Brief:
Protocol Section:
NCT02179294