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NCT Number: NCT01615731

Value of Mifepristone in Cervical Preparation Prior to Dilation and Evacuation 19-24 Weeks

A common practice for preparation for surgical abortion after 19 weeks gestation is the placement of multiple sets of osmostic dilators 1-2 days prior to the procedure. The investigators aim to study the addition of mifepristone as an adjunct to cervical dilation prior to abortion between 19-24 weeks gestation, and its potential to minimize the number of painful procedures and time in clinic (or away from work/home) that multiple sets of dilators can require. The investigators hypothesize that one set of dilators with mifepristone will result in similar procedure times and decreased "total" time as two sets of dilators.

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Key information

Conditions

Abortion, Induced Dilatation, Pathologic Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Santa Clara Valley Medical Center, San Jose, California, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Allergy to misoprostol or mifepristone

Treatment and study plan

Mifepristone

Drug

200mg Mifepristone orally

Other names: Danco, Mifeprex

Hygroscopic cervical dilators

Other

Dilapan-S osmostic cervical dilators inserted through the internal os

Other names: Dilapan-S

Misoprostol

Drug

400mcg buccal misoprostol 90 minutes pre-op

Intra-amniotic digoxin

Drug

1mg digoxin administered intra-amniotically ~24 hours pre-op

Primary outcomes

  1. Procedure Time

    Time frame: Intraoperative Time

    Measured as time from speculum insertion to removal

  2. Total Procedure Time

    Time frame: Measured at clinic visits and on OR day, over a 3 day period

Secondary outcomes

  1. Maximum Cervical Dilation

    Time frame: Measured intra-operatively

    Measured by estimate with bimanual exam and passage of largest dilator immediately prior to procedure.

  2. Adverse Events (EBL)

    Time frame: Intraoperatively

    One adverse event: Estimated Blood Loss

  3. Ease of Procedure by Blinded Surgeon

    Time frame: Measured Immediately after procedure

    Used a Visual Analogue Scale to determine the ease of procedure by blinded surgeon. The VAS ranges from 0-100. 0 being the easiest procedure the surgeon felt they had every performed and 100 being the most difficult procedure imaginable by the surgeon.

  4. Pain Perceived by Patient

    Time frame: Measured pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively)

    Used a Visual Analogue Scale to determine the pain perceived by the patient pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively). The VAS ranges from 0-100. 0 being no pain felt by the patient and 100 being the worst pain imaginable felt by the patient.

  5. Overall Patient Experience

    Time frame: Measured post operatively (at least 30 minutes, on average 1.5 hours) prior to discharge

    Used a Visual Analogue Scale to determine the patient's overall satisfaction with her experience. The VAS ranges from 0-100. 0 being a worse than expected experience, 50 being what the patient expected and 100 being a better than expected experience.

  6. Adverse Events

    Time frame: Intraoperatively and 2 weeks post operatively

    uterine perforation, uterine injury, etc.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Santa Clara Valley Medical Center

Registry information

Official study title

Value of Mifepristone in Eliminating the Need for a Second Set of Osmotic Dilators Prior to Dilation and Evacuation Between 19-24 Weeks: A Randomized Trial

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 11, 2012
Registry last updated
Feb 13, 2024

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.

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