Cervical Preparation for Same-Day Dilation & Evacuation

Not Applicable

Not yet recruiting

• Conditions: Abortion, Second Trimester; Procedural Pain; Procedural Complication

• Registration Number: NCT06799052
• Lead Sponsor: Boston Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-23
• Study First Submitted QC: 2025-01-23
• Study First Posted: 2025-01-29
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09
• Study Start: 2025-06
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Dilation & Evacuation (D&E) Operative time	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 Outcome Measures

Name	Time	Method
Participant satisfaction	after dilation, on average 3 hours	Participant satisfaction will be assessed with a 5-point Likert scale from very dissatisfied to very satisfied.
Participant preoperative pain	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.
Cervical dilation	beginning of procedure, on average 3 hours	Cervical dilation will be measured in millimeters at the beginning of the procedure by the surgeon.
Number of participants with adequate cervical dilation	beginning of procedure, on average 3 hours	Abstracted from the operative record, dilation will be considered adequate if no manual dilation is needed.
Number of participants with surgery completed in the same day	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.

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States