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AzTrials

Late AbortionNCT06478316

Intracervical Block During Laminaria Insertion

A study testing Intracervical block in people with Late Abortion and Dilation and Evacuation, run by Assaf-Harofeh Medical Center.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Late Abortion, Dilation and Evacuation
What is being tested?
Intracervical block
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
No sites listed yet
Study dates
Jul 2024to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Matan Mor, MD contact

00972506462862

MatanMorMiz@gmail.com

About this study

Official title: Pain Control With Intracervical Block, During Laminaria Insertion for Late Abortions, a Double Blind Randomized Control Trial

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

Read the detailed description
  • Research Design - Double-blind randomized study
  • Study Population - Women who are candidates for late termination of pregnancy by dilation and evacuation and approach for the insertion of laminaria will be recruited for the study.
  • The women will be divided into two groups
  • Research Group - Women who will undergo preparation for the insertion of laminaria by anesthesia with lidocaine spray, followed by an intracervical injection of 1% lidocaine.
  • Control Group - Women who will be anesthetized with lidocaine spray + intracervical injection of an inactive substance (0.9% saline).
  • Randomization will be performed using dedicated computer software according to blocks of 2-6 women.
  • All women will be offered to take 400 mg of ibuprofen about half an hour before the procedure.
  • In the research group - a 10 ml syringe will be filled with 7 ml of lidocaine and 1 ml of bicarbonate (total 70 mg of lidocaine).
  • In the control group - a 10 ml syringe will be filled with 8 ml of 0.9% NaCl saline.
  • Primary anesthesia will be performed using 10% lidocaine spray in up to 5 sprays.
  • Injection into the cervix will be performed at 3, 6, 9, 12 o'clock positions, after prior aspiration, with a 23-gauge needle, about 2 ml per point.
  • Laminaria type to be inserted - "small" diameter 3 mm, length 6.5 cm (MedGyn: Lombard, IL, USA, and Norscan: Westlake Village, CA, USA).
  • At weeks 18-20, 7-9 laminaria will be inserted.
  • Over 20 weeks - over 10 laminaria will be inserted.
  • Number of participants in the study - 70.
Being tested
Intracervical block
Medical subject headings
Dilatation, Pathologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intracervical blockProcedure or surgery

    local injection of lidocain to the cervix

Study groups in NCT06478316
Study groupRoleWhat they receive
StudyExperimentala 10 ml syringe will be filled with 7 ml of lidocaine and 1 ml of bicarbonate (total 70 mg of lidocaine).
Receives: Procedure: Intracervical block
ControlSham comparatora 10 ml syringe will be filled with 8 ml of 0.9% NaCl saline
Receives: Procedure: Intracervical block

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: During the procedure

  2. 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

    Measured: During the procedure

Secondary outcomes (2)

  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

    Measured: During and immediately after the procedure

  2. 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

    Measured: Immediately after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2024
  2. Study startJul 2024 (estimated)
  3. Primary completionJul 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06478316
Sponsor's protocol ID
ASF-0020-24
Status last verified
Jun 2024
First submitted
16 Jun 2024
Last updated
27 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 18061709

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

    PubMed 6708260

  • 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.

    PubMed 22682721

  • 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.

    PubMed 17963864

  • 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.

    PubMed 25139724

  • 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.

    PubMed 27684047

  • 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.

    PubMed 25891258

  • 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.

    PubMed 31281014

  • 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.

    PubMed 31927028

Questions about this trial

What is this clinical trial studying?

A study testing Intracervical block in people with Late Abortion and Dilation and Evacuation, run by Assaf-Harofeh Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Matan Mor, MD (00972506462862, MatanMorMiz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain level using 0-100 Visual Analog Scale (100=worst pain) (time frame: During the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06478316, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.

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