Skip to main content
OpenTrials
Completed

NCT Number: NCT01436279

Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cervical Preparation

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Boston University

Boston, Massachusetts, 02130, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mifepristone

Drug

200 mg po 20-24 hours prior to the procedure

Other names: Mifeprex, RU-486, Mifegyne

Osmotic Dilators

Device

osmotic dilators placed in the cervix 20-24 hours prior to the procedure

Other names: Laminaria, Dilapan-S, Dilapan

Primary outcomes

  1. Length of Procedure

    Time frame: Subjects will be followed from the administration of mifepristone/misoprostol or laminaria, until the end of their procedure, a total of two days.

    Interval from speculum insertion to speculum removal

Secondary outcomes

  1. Operative Time

    Time frame: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.

    Interval from initiation of vacuum aspiration to speculum removal

  2. Subject Discomfort Before the Abortion

    Time frame: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.

    Pain was subjectively described by the subjects as : None, Mild, Moderate, Severe

  3. Pain Medication (Fentanyl) During the Abortion

    Time frame: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.

    Amount of pain medication used during the procedure: reported as micrograms of fentanyl

  4. Pain Medication (Midazolam) During the Abortion

    Time frame: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.

    Amount of pain medication used during the procedure: reported as milligrams of midazolam

  5. Cervical Dilation Achieved

    Time frame: At time of abortion

    Cervical dilation at start of procedure

  6. Acceptability to Patient

    Time frame: After procedure completion

    Patient was asked whether they would choose to be in the same group again if they had a similar procedure again. The number of participants whose response was "yes" is being reported.

  7. Difficulty of Procedure

    Time frame: After completion of procedure

    Outcome measure is the number and percentage of participants where the provider rated the procedure as "difficult or very difficult". Provider assessment of difficulty of procedure categories were: "very easy", "easy", "moderate", "difficult", or "very difficult."

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • Society of Family Planning

Registry information

Acronym: SaMi2

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 19, 2011
Registry last updated
Jun 14, 2017

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.