Intracervical Block During Laminaria Insertion

NCT06478316 | Not Yet Recruiting

• 1 other identifier: ASF-0020-24
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

Whether intracervical block with lidocaine 1% is superior to sham procedure - intracervical injection of saline 0.9% - in terms of pain control.

Conditions

Late Abortion; Dilation and Evacuation

Outcome Measures

Primary Outcomes (2)

• 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

  During the procedure

• 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

  During the procedure

Secondary Outcomes (2)

• The rate of complications

  During and immediately after the procedure

• Acceptability of the procedure measured as the rate of patients who will state that they found the procedure acceptable

  Immediately after the procedure

Study Arms (2)

Study

EXPERIMENTAL

a 10 ml syringe will be filled with 7 ml of lidocaine and 1 ml of bicarbonate (total 70 mg of lidocaine).

Procedure: Intracervical block

Control

SHAM COMPARATOR

a 10 ml syringe will be filled with 8 ml of 0.9% NaCl saline

Procedure: Intracervical block

Interventions

Intracervical block PROCEDURE

local injection of lidocain to the cervix

Control; Study

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Voluntary termination of pregnancy approved by a committee or missed abortion
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Related Publications (9)

• Fox MC, Hayes JL; Society of Family Planning. Cervical preparation for second-trimester surgical abortion prior to 20 weeks of gestation. Contraception. 2007 Dec;76(6):486-95. doi: 10.1016/j.contraception.2007.09.004. Epub 2007 Nov 9.

  PMID: 18061709 RESULT

• Grimes DA, Schulz KF, Cates WJ Jr. Prevention of uterine perforation during curettage abortion. JAMA. 1984 Apr 27;251(16):2108-11.

  PMID: 6708260 RESULT

• Borgatta L, Roncari D, Sonalkar S, Mark A, Hou MY, Finneseth M, Vragovic O. Mifepristone vs. osmotic dilator insertion for cervical preparation prior to surgical abortion at 14-16 weeks: a randomized trial. Contraception. 2012 Nov;86(5):567-71. doi: 10.1016/j.contraception.2012.05.002. Epub 2012 Jun 6.

  PMID: 22682721 RESULT

• Prairie BA, Lauria MR, Kapp N, Mackenzie T, Baker ER, George KE. Mifepristone versus laminaria: a randomized controlled trial of cervical ripening in midtrimester termination. Contraception. 2007 Nov;76(5):383-8. doi: 10.1016/j.contraception.2007.07.008. Epub 2007 Oct 4.

  PMID: 17963864 RESULT

• Mercier RJ, Liberty A. Intrauterine lidocaine for pain control during laminaria insertion: a randomized controlled trial. Contraception. 2014 Dec;90(6):594-600. doi: 10.1016/j.contraception.2014.07.008. Epub 2014 Jul 23.

  PMID: 25139724 RESULT

• Shaw KA, Lerma K. Update on second-trimester surgical abortion. Curr Opin Obstet Gynecol. 2016 Dec;28(6):510-516. doi: 10.1097/GCO.0000000000000318.

  PMID: 27684047 RESULT

• Ramesh S, Roston A, Zimmerman L, Patel A, Lichtenberg ES, Chor J. Misoprostol 1 to 3 h preprocedure vs. overnight osmotic dilators prior to early second-trimester surgical abortion. Contraception. 2015 Sep;92(3):234-40. doi: 10.1016/j.contraception.2015.04.005. Epub 2015 Apr 16.

  PMID: 25891258 RESULT

• Lerma K, Blumenthal PD. Current and potential methods for second trimester abortion. Best Pract Res Clin Obstet Gynaecol. 2020 Feb;63:24-36. doi: 10.1016/j.bpobgyn.2019.05.006. Epub 2019 May 25.

  PMID: 31281014 RESULT

• Creinin MD, Schimmoeller NR, Matulich MC, Hou MY, Melo J, Chen MJ. Gabapentin for pain management after osmotic dilator insertion and prior to dilation and evacuation: A randomized controlled trial. Contraception. 2020 Mar;101(3):167-173. doi: 10.1016/j.contraception.2019.12.001. Epub 2020 Jan 10.

  PMID: 31927028 RESULT

MeSH Terms

Conditions

Dilatation, Pathologic

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Matan Mor, MD

  Assaf-Harofeh Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matan Mor, MD

CONTACT

00972506462862; MatanMorMiz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2024
• First Posted: June 27, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share