Brief Summary
The Investigator team hypothesizes that in a randomized trial comparing mifepristone-alone or misoprostol-alone for cervical preparation for procedural abortions at 12 to 16 weeks in hospital-based care, the proportion of patients who achieve successful cervical dilation will be different between the study groups.
Brief Title
Mifepristone vs Misoprostol
Detailed Description
Cervical preparation is a critical component for the provision of safe abortion care in the later first trimester and beyond. The risk of surgical complications increases at 12 to 13 weeks gestation and routine use of cervical preparation is recommended. Cervical preparation options include misoprostol, mifepristone, and cervical dilators. Regimen choice is often guided by provider comfort, preference, or institutional guidelines. Misoprostol offers the advantage of facilitating same-day procedures, but side effects like pain and gastrointestinal symptoms can negatively affect patients' experiences. Furthermore, using misoprostol can pose logistical challenges in hospital-based main operating room environments, where abortions occur concurrently with all other surgical cases. Mifepristone is better tolerated than misoprostol but requires a multiple-day protocol for administration, which can pose logistical challenges.
Several studies demonstrate mifepristone's efficacy and safety as a cervical ripening agent for up to 16 weeks' gestation, however, despite its effectiveness, mifepristone for cervical preparation before procedural abortion has previously been limited by availability and cost. Recent studies demonstrating mifepristone's adjunctive benefit with osmotic dilators later in pregnancy, however, have broadened its use.
While most abortion care in the United States occurs in outpatient settings, about 3% occur in hospitals. This is expected to increase as the Dobbs versus Jackson Women's Health Organization decision exacerbates disparities in abortion access. In hospital-based abortion care, particularly at academic centers providing abortion training, there is a pressing need for innovative measures for cervical ripening. The Complex Family Planning Fellowship-trained faculty members at Montefiore will serve as research study surgeons. Cases will be performed in the main operating room under sedation or general anesthesia as determined by the anesthesiologist. A paracervical block of 20cc 1% lidocaine, with or without vasopressin, will be administered in accordance with standard practices.
Several studies demonstrate mifepristone's efficacy and safety as a cervical ripening agent for up to 16 weeks' gestation, however, despite its effectiveness, mifepristone for cervical preparation before procedural abortion has previously been limited by availability and cost. Recent studies demonstrating mifepristone's adjunctive benefit with osmotic dilators later in pregnancy, however, have broadened its use.
While most abortion care in the United States occurs in outpatient settings, about 3% occur in hospitals. This is expected to increase as the Dobbs versus Jackson Women's Health Organization decision exacerbates disparities in abortion access. In hospital-based abortion care, particularly at academic centers providing abortion training, there is a pressing need for innovative measures for cervical ripening. The Complex Family Planning Fellowship-trained faculty members at Montefiore will serve as research study surgeons. Cases will be performed in the main operating room under sedation or general anesthesia as determined by the anesthesiologist. A paracervical block of 20cc 1% lidocaine, with or without vasopressin, will be administered in accordance with standard practices.
Central Contacts
Central Contact Role
Contact
Central Contact Phone
516-587-3297
Central Contact Email
lfletcher@montefiore.org
Central Contact Role
Contact
Central Contact Phone
718-405-8260
Central Contact Email
adanvers@montefiore.org
Completion Date
Completion Date Type
Estimated
Conditions
Cervical Preparation
Eligibility Criteria
Inclusion Criteria:
* English or Spanish-speaking
* Capacity to consent
* Seeking induced abortion of a singleton pregnancy
* Between 12 weeks, 0 days and 16 weeks, 6 days (based on age at day of surgery)
Exclusion Criteria:
* History of more than one prior Cesarean delivery
* Sonographic evidence of placenta previa
* Sonographic concern for morbidly adherent placenta
* Prior obstetric hemorrhage requiring transfusion
* Obstructive cervical or lower uterine segment fibroid
* Current therapeutic anticoagulation use
* Cerclage in situ
* History of more than one prior cervical excisional procedure
* BMI greater than 45 kg/m\^2
* English or Spanish-speaking
* Capacity to consent
* Seeking induced abortion of a singleton pregnancy
* Between 12 weeks, 0 days and 16 weeks, 6 days (based on age at day of surgery)
Exclusion Criteria:
* History of more than one prior Cesarean delivery
* Sonographic evidence of placenta previa
* Sonographic concern for morbidly adherent placenta
* Prior obstetric hemorrhage requiring transfusion
* Obstructive cervical or lower uterine segment fibroid
* Current therapeutic anticoagulation use
* Cerclage in situ
* History of more than one prior cervical excisional procedure
* BMI greater than 45 kg/m\^2
Inclusion Criteria
Inclusion Criteria:
* English or Spanish-speaking
* Capacity to consent
* Seeking induced abortion of a singleton pregnancy
* Between 12 weeks, 0 days and 16 weeks, 6 days (based on age at day of surgery)
* English or Spanish-speaking
* Capacity to consent
* Seeking induced abortion of a singleton pregnancy
* Between 12 weeks, 0 days and 16 weeks, 6 days (based on age at day of surgery)
Gender
Female
Gender Based
false
Keywords
Procedural Abortion
Surgical Abortion
Abortion, First Trimester
Cervical Dilators
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
45 Years
Minimum Age
18 Years
NCT Id
NCT06502158
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2024-15999
Overall Status
Recruiting
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Mifepristone Versus Misoprostol for Cervical Preparation Prior to Procedural Abortion at 12 to 16 Weeks' Gestation in an Academic Medical Center: a Randomized Controlled Pilot Trial
Primary Outcomes
Outcome Description
The proportion of participants achieving intended dilation at the start of the procedure will be summarized by treatment group and reported in percentages. Achievement of intended dilation will be determined by the attending surgeon. Overdilation resulting in passage of products of conception prior to time of surgery will be characterized as a treatment failure.
Outcome Measure
Percentage of participants achieving Intended dilation
Outcome Time Frame
At time of surgery
Secondary Outcomes
Outcome Description
Cervical dilation in centimeters (cm) at start of procedure will be summarized and reported using basic descriptive statistics.
Outcome Time Frame
Start of the Procedure
Outcome Measure
Cervical dilation at start of procedure
Outcome Description
Total surgical time will quantified and reported by treatment arm using basic descriptive statistics.
Outcome Time Frame
Start to end of procedure, up to 4 hours
Outcome Measure
Surgical time
Outcome Description
Estimated blood loss will be quantified and reported per treatment arm using basic descriptive statistics.
Outcome Time Frame
Start to end of procedure, up to 4 hours
Outcome Measure
Estimated blood loss
Outcome Description
The presence of peri-operative complications, defined as instances of hemorrhage, use of uterotonic medications, passage of products of conception prior to time of surgery, instances of extramural delivery, or need for unscheduled procedures, will be summarized and reported as "Yes" or "No" using basic descriptive statistics.
Outcome Time Frame
From preoperative visit to discharge, up to 2 days
Outcome Measure
Presence of Intraoperative Complications
Outcome Description
Patient Satisfaction will be assessed by responses to a survey administered in the Postoperative Care Unit (PACU) following the procedure. The patient will be asked to rate their satisfaction with the procedure on a 6-point Likert scale ranging from 0 (Not at all satisfied) to 5 (Most satisfied). Responses will be summarized by treatment group using basic descriptive statistics. Increased scores are associated with increased satisfaction.
Outcome Time Frame
From preoperative visit to discharge, up to 2 days
Outcome Measure
Patient Satisfaction
Outcome Description
Provider Satisfaction will be assessed by responses to a survey administered following the procedure. The care provider will be asked to rate their satisfaction with the procedure on a 6-point Likert scale ranging from 0 (Not at all satisfied) to 5 (Most satisfied). Responses will be summarized by treatment group using basic descriptive statistics. Increased scores are associated with increased satisfaction.
Outcome Time Frame
From preoperative visit to discharge, up to 2 days
Outcome Measure
Provider Satisfaction
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
45
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Antoinette Danvers
Investigator Email
adanvers@montefiore.org