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NCT Number: NCT06799052

Cervical Preparation for Same-Day Dilation & Evacuation

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.

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Key information

Conditions

Abortion, Second Trimester Behavior Health Behavior Neurologic Manifestations Pain Pain, Procedural Pathological Conditions, Signs and Symptoms Patient Satisfaction Procedural Complication Procedural Pain Signs and Symptoms Treatment Adherence and Compliance

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • English- or Spanish-speaking
  • Singleton intrauterine pregnancy

Exclusion criteria

  • Allergy to betadine, aquacryl hydrogel, latex-free silicone single-balloon catheter, synthetic or natural osmotic dilators
  • Fetal demise or known fetal anomaly
  • BMI >45
  • Incarceration or other inability to give informed consent
  • Decide to undergo cervical preparation overnight prior to next-day D&E

Treatment and study plan

Transcervical single-balloon catheter

Device

A single-balloon (Foley) catheter will be placed through the cervix and filled to 30cc of water or saline. The balloon will remain in the participant until their procedure, usually 3-4 hours, or earlier if it falls out on its own.

Other names: Foley catheter

Synthetic osmotic dilators

Device

Dilators will be maintained in the cervix between 3-4 hours, during which each dilator rod will swell several times its initial dried diameter.

Other names: Dilapan-S, seaweed laminaria

Primary outcomes

  1. Dilation & Evacuation (D&E) Operative time

    Time frame: at end of procedure about 20 minutes

    the total duration in D&E operative time measured in minutes. Operative start time will be marked as the time that the speculum is inserted for the first time. Operative end time will be marked as the time that the speculum is removed at the end of the case.

Secondary outcomes

  1. Participant preoperative pain

    Time frame: every hour until procedure, on average 3 hours

    Participant pain will be assessed via a 100 point visual analog scale immediately post-cervical preparation and at every hour interval until their D&E. Higher scores are associated with more pain.

  2. Participant satisfaction

    Time frame: after dilation, on average 3 hours

    Participant satisfaction will be assessed with a 5-point Likert scale from very dissatisfied to very satisfied.

  3. Cervical dilation

    Time frame: beginning of procedure, on average 3 hours

    Cervical dilation will be measured in millimeters at the beginning of the procedure by the surgeon.

  4. Number of participants with adequate cervical dilation

    Time frame: beginning of procedure, on average 3 hours

    Abstracted from the operative record, dilation will be considered adequate if no manual dilation is needed.

  5. Number of participants with surgery completed in the same day

    Time frame: 12 months

    Abstracted from the electronic medical record, whether the surgery was completed in the same day as the dilation will be recorded as yes or no.

Study contacts

Contact information is provided by the study sponsor or research team.

Alana Martinusen, MPH

CONTACT

[email protected]

617 383 3500

Anjanique Mariquit Lu, MD

CONTACT

[email protected]

617 414 5716

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Registry information

Official study title

Same-Day Cervical Preparation Prior to Second Trimester Dilation & Evacuation: A Noninferiority Randomized Control Trial Comparing Single-Balloon Catheter and Osmotic Dilators

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2025
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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