Intracervical Block During Laminaria Insertion (NCT06478316) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Intracervical Block During Laminaria Insertion
70 participantsStarted 2024-07
Plain-language summary
Whether intracervical block with lidocaine 1% is superior to sham procedure - intracervical injection of saline 0.9% - in terms of pain control.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Women who have a guardian for any reason
* Women with a history of cesarean section
* Women with abnormal placental implantation, such as placenta previa or suspected placenta accreta
* Women with a psychiatric illness
* Women with a history of alcoholism or drug abuse
* Women who required a "two-stage" laminaria insertion will not be included in the analysis. In cases where the cervix does not allow the insertion of the required number of laminaria, the process is carried out in two stages: in the first stage, the maximum possible number is inserted, the woman is hospitalized, and after a few hours when some initial dilation of the cervix has occurred, the laminaria are removed and new ones are inserted according to the required number
What they're measuring
1
Pain level using 0-100 Visual Analog Scale (100=worst pain)
Timeframe: During the procedure
2
Rate of patient reporting severe pain (VAS 75-100) during laminaria insertion