Cervical Preparation for Abortion

Overseen By Alana Martinusen, MPH

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Boston Medical Center

Disqualifiers: Allergy, Fetal anomaly, BMI >45, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

32 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a noninferiority randomized control trial of two cervical preparation methods prior to same-day Dilation \& Evacuation (D\&E). Cervical preparation is a process that softens and dilates the cervix prior to a procedure. The primary objective is to evidence noninferiority of cervical preparation using a single-balloon catheter method when compared to a group receiving osmotic dilators, specifically in D\&E operative time. Secondary objectives will compare the two methods for adequate dilation, ability to complete the operation in the same day, participant pain, satisfaction and safety.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment using synthetic osmotic dilators and a transcervical single-balloon catheter for cervical preparation for abortion?

Research shows that synthetic osmotic dilators are effective for softening and opening the cervix before surgical abortion, similar to other methods like laminaria tents. They can be used on the same day as the procedure, which may increase access to early second-trimester abortions. ^{1 2 3 4 5}

Is cervical preparation with synthetic osmotic dilators safe for humans?

Research shows that synthetic osmotic dilators are generally safe for cervical preparation before surgical abortion. They may cause some discomfort but do not pose a substantial risk of magnesium toxicity and can reduce the risk of infection and cervical injury compared to not using any device. ^{1 2 3 4 6}

How is the treatment with synthetic osmotic dilators and a transcervical single-balloon catheter different from other treatments for cervical preparation before abortion?

This treatment is unique because it uses synthetic osmotic dilators, which can be used on the same day as the procedure, potentially increasing access to early second-trimester surgical abortions. Unlike some other methods that require overnight preparation, this approach may offer a more convenient and less time-consuming option for cervical preparation. ^{1 2 3 4 7}

Research Team

Anjanique Mariquit Lu, MD

Principal Investigator

Boston Medical Center, Obstetrics and Gynecology

Eligibility Criteria

This trial is for individuals requiring cervical preparation before a same-day Dilation & Evacuation (D&E) procedure. Specific eligibility criteria are not provided, but typically participants would be those who need the procedure and meet certain health standards set by the study.

Inclusion Criteria

Between 16 weeks 0 days - 18 weeks 6 days gestational age who are pursuing termination, based on reliable gestational age (defined as ultrasonography performed by a clinical provider, or a certain last menstrual period)

Able to provide informed consent

Singleton intrauterine pregnancy

Exclusion Criteria

Incarceration or other inability to give informed consent

My BMI is over 45.

Allergy to betadine, aquacryl hydrogel, latex-free silicone single-balloon catheter, synthetic or natural osmotic dilators

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cervical Preparation

Participants undergo cervical preparation using either a single-balloon catheter or osmotic dilators prior to Dilation & Evacuation (D&E)

Same day

1 visit (in-person)

Dilation & Evacuation (D&E) Procedure

Participants undergo the D&E procedure following cervical preparation

Approximately 20 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety, pain, and satisfaction after the procedure

3 hours post-procedure

Treatment Details

Interventions

• Synthetic osmotic dilators
• Transcervical single-balloon catheter

Trial Overview The trial is testing two methods of cervical preparation: synthetic osmotic dilators versus a transcervical single-balloon catheter. It aims to show that the balloon method is not worse than dilators in terms of operation time, dilation adequacy, ability to complete same-day surgery, pain levels, satisfaction, and safety.

Participant Groups

Group I: Transcervical single-balloon catheter group Experimental Treatment 1 Intervention

Participants randomized to this arm will have cervical dilation done using a transcervical single-balloon catheter.

Group II: Osmotic dilators group Active Control 1 Intervention

Participants randomized to this arm will have cervical dilation done using osmotic dilators.

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Mifepristone and misoprostol compared to osmotic dilators for cervical preparation prior to surgical abortion at 15-18 weeks' gestation: a randomised controlled non-inferiority trial. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Two cervical preparation regimens prior to surgical abortion at 10-14 weeks of gestation: A randomized clinical trial. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Cervical dilation from laminaria tents and synthetic osmotic dilators used for 6 hours before abortion. [2009]

4. United States pubmed.ncbi.nlm.nih.gov

Same-day synthetic osmotic dilators compared with overnight laminaria before abortion at 14-18 weeks of gestation: a randomized controlled trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

The use of laminarias for osmotic dilation of the cervix in gynecological brachytherapy applications. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Use of osmotic dilators to facilitate induced midtrimester abortion: clinical evaluations. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Cervical preparation for first trimester surgical abortion. [2018]