Pre-Operative Effects of Mifepristone on Dilation and Evacuation Services (POEM)

Protocol Title: Reducing Complications and Patient Barriers in Second Trimester Abortion: Pre-Operative Effects of Mifepristone (POEM) on Dilatation and Evacuation Services

This research study investigates the use of a drug, mifepristone, given before second trimester abortion. Mifepristone is a medication that is approved for medical abortion during the first trimester. It also has been used prior to abortion in the early seconds trimester (14-16 weeks gestation) and for medication abortion in the second trimester (also called induction abortion). This medication has effects on the uterus that may help dilate, or open, the cervix. Abortion requires opening of the cervix to safely remove the pregnancy. Cervical dilation, or opening, is essential to both ease of completion of procedure and reducing complications that can occur. These complications include laceration, or tearing, of the cervix and perforation of the uterus (a hole made unintentionally in the muscle wall of the uterus) and are not expected to be increased in the study. Dilation of the cervix is usually achieved by placing thin rods (cervical dilators) through the cervix. These rods then absorb the moisture of the vagina and slowly expand, opening the cervix. The standard method of dilation is performed at the clinic and involves the placement of cervical dilators the day before the procedure. This procedure can be uncomfortable. A prior study showed that mifepristone reduces the number of osmotic dilators that need to be placed prior to the procedure after 19 weeks gestation. We aim to investigate mifepristone as a potential adjunct to cervical dilation or used alone, without dilators, as method of cervical preparation with the hopes of reducing barriers imposed by painful procedures and time in clinic and away from work/home that the current approach involving dilators requires.

Study Overview

• Status: Completed
• Conditions: Legally Induced Abortion Without Mention of Complication
• Intervention / Treatment: Other: Hygroscopic cervical dilators; Drug: Misoprostol; Drug: Intra-amniotic digoxin; Drug: Mifepristone

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Jose, California, United States, 95128
      • Santa Clara Valley Medical Center
    • Stanford, California, United States, 94305
      • Stanford University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• >18 years old
• Viable, Singleton pregnancy
• Voluntarily seeking abortion between 19 and 24 wks gestation
• Able to give informed consent and comply with study protocol
• Fluent in English or Spanish

Exclusion Criteria:

• Allergy to misoprostol or mifepristone

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Dilapan-Placebo; The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.	Other: Hygroscopic cervical dilators; Dilapan-S osmotic cervical dilators inserted through the internal os.; Other Names: Dilapan-S; Drug: Misoprostol; 400 mcg buccal misoprostol 90 pre-op; Drug: Intra-amniotic digoxin; 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation
Active Comparator: Dilapan-Mifepristone; The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.	Other: Hygroscopic cervical dilators; Dilapan-S osmotic cervical dilators inserted through the internal os.; Other Names: Dilapan-S; Drug: Misoprostol; 400 mcg buccal misoprostol 90 pre-op; Drug: Intra-amniotic digoxin; 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation; Drug: Mifepristone; 200 mcg Mifepristone orally; Other Names: Mifeprex; Danco
Experimental: Mifepristone; The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.	Drug: Misoprostol; 400 mcg buccal misoprostol 90 pre-op; Drug: Intra-amniotic digoxin; 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation; Drug: Mifepristone; 200 mcg Mifepristone orally; Other Names: Mifeprex; Danco

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Time	Measured as time from speculum insertion to removal	Intraoperative Time, Collected immediately within procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Uterine perforation	Intraoperatively and 2 weeks post operatively

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Santa Clara Valley Medical Center
• Investigators: Principal Investigator: Kate Shaw, MD, Stanford University

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: May 22, 2013
• First Submitted That Met QC Criteria: May 24, 2013
• First Posted (Estimated): May 27, 2013

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Mifepristone; Induced Abortion; Dilation and Evacuation; Cervical Preparation; Osmotic Dilators
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Enzyme Inhibitors; Gastrointestinal Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Protective Agents; Cardiotonic Agents; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Anti-Ulcer Agents; Contraceptives, Oral, Synthetic; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Luteolytic Agents; Abortifacient Agents, Steroidal; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Menstruation-Inducing Agents; Digoxin; Misoprostol; Mifepristone
• Other Study ID Numbers: SU-05132013-108659; PF-108666 (Other Grant/Funding Number: Packard Foundation)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No