Clinical trial NCT01436279: Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks
Official title: Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Preparation
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2011-09-19
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study the investigators plan to compare mifepristone and misoprostol use to osmotic dilator use for cervical preparation for 15-18 week surgical abortion. Mifepristone would be given 24 hours prior to abortion, and misoprostol 400 mcg would be administered buccally 2 hours prior to abortion. Osmotic dilators are the method currently used in our institution, and are placed 24 hours prior to abortion. The primary outcome will be the length of the procedure. Secondary outcomes will include amount of dilation achieved, ease of procedure, participant's assessment of discomfort before mifepristone or dilators, discomfort during the abortion procedure, acceptability to participants, and acceptability to staff.


Eligibility criteria: Inclusion Criteria:

* Women 18-50 years of age undergoing surgical termination of pregnancy
* English or Spanish speaking
* Gestational age between 15 and 18 weeks gestation on day of abortion (inclusive), by ultrasound dating
* Eligible for a dilation and evacuation abortion with local anesthesia and sedation
* Ultrasound for dating purposes done within the last two weeks

Exclusion Criteria:

* Intrauterine infection
* Fetal demise
* Ruptured membranes
* Multiple gestation
* Uterine anomaly or significant distortion of the uterus with fibroids
* BMI greater than 45
* Inability to place osmotic dilators
* Active substance abuse or intoxication
* Adrenal failure, chronic corticosteroid use, anticoagulant usage
* Severe cervicitis, until treated and resolved
* Prior Cesarean section

Primary outcomes:
measure: Length of Procedure
timeFrame: Subjects will be followed from the administration of mifepristone/misoprostol or laminaria, until the end of their procedure, a total of two days.
Secondary outcomes:
measure: Operative Time
timeFrame: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.
measure: Subject Discomfort Before the Abortion
timeFrame: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.
measure: Pain Medication (Fentanyl) During the Abortion
timeFrame: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.
measure: Pain Medication (Midazolam) During the Abortion
timeFrame: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.
measure: Cervical Dilation Achieved
timeFrame: At time of abortion
measure: Acceptability to Patient
timeFrame: After procedure completion
measure: Difficulty of Procedure
timeFrame: After completion of procedure
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Sarita Sonalkar, MD
role: PRINCIPAL_INVESTIGATOR
References: