Intracervical Block During Laminaria Insertion

Launched by ASSAF-HAROFEH MEDICAL CENTER · Jun 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a pain relief method called an intracervical block, which involves injecting a medication called lidocaine, compared to a sham procedure where a saltwater solution is injected instead. The goal is to see if the lidocaine injection offers better pain control during a procedure called dilation and evacuation (D&E) for women experiencing late abortion or missed abortion.

To be eligible for the trial, participants must be women aged between 18 and 22.5 weeks pregnant with a singleton pregnancy (one baby) who are seeking a voluntary termination of pregnancy approved by a medical committee or have had a missed abortion. However, women with certain conditions, such as multiple pregnancies, specific medical histories, or language barriers, cannot participate. If you choose to join the study, you will receive either the lidocaine injection or the saltwater injection, and researchers will monitor your pain levels during the procedure to determine which method is more effective. It’s important to know that the trial is not yet recruiting participants, so it’s a good idea to keep an eye out for updates if you're interested.

Gender

FEMALE

Eligibility criteria

• 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