A Phase 3 interventional study of remifentanil and paracetamol in Breech Presentation and Pregnancy, sponsored by Basque Health Service. Completed at 1 site in Spain. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-04-14.
Sponsored by Basque Health Service · Phase 3, Interventional, and Treatment
BACKGROUND: Between 3-4% of pregnancies carried to term, the fetuses are in breech presentation. The external version is a maneuver gynecological used to turn a breech in cephalic presentation. For treatment of pain suggests the use of μ agonist remifentanil for fast action and elimination.
OBJECTIVE: To compare the effectiveness of remifentanil for pain management in external version.
PATIENTS: Pregnant for 36 weeks or more with breech presentation who met the inclusion criteria and sign the consent. Participants will be randomized into two groups before the procedure.
Group intervention: paracetamol and remifentanil Control group: paracetamol and placebo DETERMINATIONS: VAS pain level, percentage of success of the maneuver and adverse events.
Statistical Analysis: Comparison of pain recorded by VAS in both groups and comparison of adverse events
41 studies on the registry are indexed under Breech Presentation; 10 are open to participants now.
This study's planned enrollment of 60 is below the median of 119 across 31 interventional studies indexed under Breech Presentation.
Browse Breech Presentation studies →Basque Health Service is the lead sponsor of 57 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: remifentanil
intravenous paracetamol 1g
Drug: paracetamol
intervention: intravenous paracetamol 1g and remifentanil 1mg/100ml in 100ml of 0.9% saline.
Control group: intravenous paracetamol 1g
Also known as: acetoaminophen
Degree of decrease in pain experienced by patients during the maneuver according to the VAS
Time frame: 10 minutes
Proportion of patients in each group in which the procedure is effective and avoids performing a Caesarean section.
Time frame: 1 day
Number of adverse events and severity
Time frame: 1 day
This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Remifentanil
Basque Health Service