Montefiore Medical Center
The Bronx, New York, 10467, United States
Location status: Recruiting
Location contact
Antoinette Danvers, MD, MSCR, MBA
PRINCIPAL_INVESTIGATOR
Laura Fletcher, MD, MPH
CONTACT
NCT Number: NCT06502158
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.
Interested in participating?
Request Info18 year–45 year
Female
Interventional
Phase 1
The Bronx, New York, 10467, United States
Location status: Recruiting
Antoinette Danvers, MD, MSCR, MBA
PRINCIPAL_INVESTIGATOR
Laura Fletcher, MD, MPH
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
200 milligrams (mg)
600 micrograms (ug)
Other names: Cytotec
Time frame: At time of surgery
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.
Time frame: Start of the Procedure
Cervical dilation in centimeters (cm) at start of procedure will be summarized and reported using basic descriptive statistics.
Time frame: Start to end of procedure, up to 4 hours
Total surgical time will quantified and reported by treatment arm using basic descriptive statistics.
Time frame: Start to end of procedure, up to 4 hours
Estimated blood loss will be quantified and reported per treatment arm using basic descriptive statistics.
Time frame: From preoperative visit to discharge, up to 2 days
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.
Time frame: From preoperative visit to discharge, up to 2 days
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.
Time frame: From preoperative visit to discharge, up to 2 days
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.
Contact information is provided by the study sponsor or research team.
Antoinette Danvers, MD, MSCR, MBA
CONTACT
Laura Fletcher, MD, MPH
CONTACT
Montefiore Medical Center
Other
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
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.
Published trials that share one or more normalized conditions with this study.
NCT07641595
Cervical Preparation, Evening Primorose Oil
Sohag, Egypt
View Trial DetailsNCT03080493
Abortion, Induced, Cervical Preparation
Sacramento, California, United States
View Trial DetailsNCT01436279
Cervical Preparation
Boston, Massachusetts, United States
View Trial DetailsNCT00775983
Cervical Preparation
San Francisco, California, United States
View Trial Details