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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods for preparing the cervix (the lower part of the uterus) before a same-day Dilation & Evacuation (D&E) procedure. The goal is to determine if a transcervical single-balloon catheter is as effective as synthetic osmotic dilators, with a focus on procedure duration. Researchers also compare these methods in terms of pain, satisfaction, and safety. Women between 16 and 18 weeks of pregnancy, seeking a termination, and able to give informed consent are suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to important research that could enhance future medical procedures.

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 prior data suggests that these cervical preparation methods are safe?

Research has shown that both the transcervical single-balloon catheter and synthetic osmotic dilators are safe for cervical preparation.

Studies have found the transcervical single-balloon catheter to be effective and safe, comparable to other balloon methods. Most individuals tolerate this method well.

Research indicates that synthetic osmotic dilators are safe and effective for cervical preparation, particularly in medical and surgical abortions up to 24 weeks of pregnancy. They are linked to fewer complications, such as cervical tears.

Both methods have been used safely in various settings, suggesting they are well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two distinct methods for cervical preparation in abortion procedures. Traditional methods typically rely on osmotic dilators, which gradually absorb moisture and expand to dilate the cervix. In contrast, the transcervical single-balloon catheter offers a mechanical approach, using a balloon to gently open the cervix. This method could potentially offer quicker dilation with more control, reducing procedure time and possibly improving patient comfort. By comparing these two techniques, researchers hope to identify a more efficient and patient-friendly option for cervical dilation.

What evidence suggests that this trial's cervical preparation methods could be effective for D&E procedures?

This trial will compare the effectiveness of two methods for cervical preparation: the transcervical single-balloon catheter and synthetic osmotic dilators. Studies have shown that both methods effectively prepare the cervix. Research indicates that the single-balloon catheter, often used to start labor, gently widens the cervix, making it ready for procedures like D&E (Dilation and Evacuation). Previous findings suggest this method is both safe and effective. Similarly, synthetic osmotic dilators like Dilapan-S have proven safe and effective, with some studies showing fewer complications during procedures. These dilators absorb moisture and slowly expand to open the cervix. Both methods effectively prepare the cervix for D&E procedures. ^{1 2 3 5 6}

Who Is on the Research Team?

Anjanique Mariquit Lu, MD

Principal Investigator

Boston Medical Center, Obstetrics and Gynecology

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30032065/

Synthetic osmotic dilators for cervical preparation prior to ... Conclusion: Dilapan-S is a safe and effective method for cervical preparation for medical and surgical abortions up to 24 weeks' gestation. It allows medical ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211518303403

Synthetic osmotic dilators for cervical preparation prior to ... For medical abortions and surgical abortions, an average of 3 osmotic dilators (Dilapan-S) for 4–7 hours provided effective cervical preparation. •. Medical ...

3. societyfp.org societyfp.org/wp-content/uploads/2024/05/Society-of-Family-Planning-clinical-recommendations-Cervical-preparation-for-dilation-and-evacuation-at-2024-weeks-gestation.pdf

Cervical preparation for dilation and evacuation at ... After the use of osmotic dilators was introduced, repaired cervical laceration decreased signifi- cantly, to 1.2% (p < 0.05). Early data on abortion morbidity ...

4. cochrane.org cochrane.org/evidence/CD007310_what-are-benefits-and-risks-different-cervical-preparation-methods-surgical-abortion-second

What are the benefits and risks of different cervical ... Misoprostol plus osmotic dilators probably reduces procedure time; increases dilation achieved; reduces need for additional dilation; and has ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jmwh.70017?af=R

A Comparison of Synthetic Osmotic Dilators and ... Synthetic osmotic dilators are a safe, effective, and viable option for labor induction, reducing maternal risks of uterine hyperstimulation.

6. ejog.org ejog.org/article/S0301-2115(16)30445-6/fulltext

Synthetic osmotic dilator prior to medical or surgical abortion Conclusion: We were able to show that the application of synthetic osmotic dilators is a safe and efficient method of cervical priming prior to surgical as well ...