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NCT Number: NCT01862991

Pre-Operative Effects of Mifepristone on Dilation 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.

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Key information

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 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

Treatment and study plan

Hygroscopic cervical dilators

Other

Dilapan-S osmotic cervical dilators inserted through the internal os.

Other names: Dilapan-S

Misoprostol

Drug

400 mcg buccal misoprostol 90 pre-op

Intra-amniotic digoxin

Drug

1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation

Mifepristone

Drug

200 mcg Mifepristone orally

Other names: Danco, Mifeprex

Primary outcomes

  1. Procedure Time

    Time frame: Intraoperative Time, Collected immediately within procedure

    Measured as time from speculum insertion to removal

Secondary outcomes

  1. Adverse Events

    Time frame: Intraoperatively and 2 weeks post operatively

    Uterine perforation

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Santa Clara Valley Medical Center

Registry information

Official study title

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

Acronym: POEM

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
May 27, 2013
Registry last updated
Feb 14, 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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