Abortion, Second Trimester, Procedural Complication, Procedural Pain
Conditions
Keywords
Cervical Dilation and Evacuation (D&E), Transcervical single-balloon catheter, Osmotic dilators, Adequate dilation, Patient satisfaction
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.
Interventions
DEVICETranscervical single-balloon catheter
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.
DEVICESynthetic osmotic dilators
Dilators will be maintained in the cervix between 3-4 hours, during which each dilator rod will swell several times its initial dried diameter.
Sponsors
Boston Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a noninferiority parallel randomized control trial of two cervical preparation methods prior to same-day D&E.
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
United States
Contacts
CONTACTAnjanique Mariquit Lu, MD
CONTACTAlana Martinusen, MPH
PRINCIPAL_INVESTIGATORAnjanique Mariquit Lu, MD
Boston Medical Center, Obstetrics and Gynecology
Outcome results
None listed