Intracervical Block During Laminaria Insertion
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorAssaf-Harofeh Medical Center
About this trial
Whether intracervical block with lidocaine 1% is superior to sham procedure - intracervical injection of saline 0.9% - in terms of pain control.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Voluntary termination of pregnancy approved by a committee or missed abortion
18.0 to 22.5 gestational week (The gestational age in the case of a missed abortion is determined by the BPD - Biparietal Diameter, which is the determining measure for the ability to perform D&E.)
Singleton pregnancy
Disqualifiers
Multiple pregnancy
Women undergoing the procedure urgently due to cervical insufficiency, inevitable abortion, premature rupture of membranes, or suspected chorioamnionitis
Allergy to lidocaine
Women who do not speak Hebrew or English
Trial design
Design model
Parallel
Treatments tested in this trial
Intracervical block
Procedure/Surgerylocal injection of lidocain to the cervix
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: StudyExperimental treatment 1 intervention
Group B: ControlSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain level using 0-100 Visual Analog Scale (100=worst pain)
Patients will be asked to rate their maximal pain level during the procedure of laminaria insertion using 0-100 Visual Analog Scale
Time frame
During the procedure2
Rate of patient reporting severe pain (VAS 75-100) during laminaria insertion
Patients will be asked to rate their maximal pain level during the procedure of laminaria insertion using 0-100 Visual Analog Scale
Time frame
During the procedureSecondary outcomes
1
The rate of complications
Complications during laminaria insertion: rupture of the membranes, cervical bleeding, false route; complication during dilation and evacuation - failure to complete the dilation and evacuation procedure
Time frame
During and immediately after the procedure2
Acceptability of the procedure measured as the rate of patients who will state that they found the procedure acceptable
Patients will be asked to state whether they find the procedure they undergone acceptable
Time frame
Immediately after the procedureLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: