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Completed

NCT Number: NCT00986921

Mifepristone Versus Laminaria Insertion for Cervical Preparation Prior to Surgical Abortion at 14-16 Weeks

Women who are requesting pregnancy termination at 14-16 weeks, who would normally have osmotic dilator insertion the day before their procedure, would be asked if they wanted to participate. Participants would be randomized to two groups: first, dilator insertion as usual, or second, mifepristone taken the day before the procedure.

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Key information

Conditions

Abortion

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • women aged 18-45 having pregnancy termination at 14-16 weeks

Exclusion criteria

  • multiple gestation, pre-existing infection, contraindication to osmotic dilators, unable to obtain proper consent

Treatment and study plan

mifepristone 200 mg

Drug

mifepristone would be given the day before the procedure

osmotic dilator insertion

Device

osmotic dilators (3-6) would be inserted as usual the day before the procedure

Primary outcomes

  1. Time for Completion of Procedure

    Time frame: Performance and completion of the abortion procedure takes 10-20 minutes. The length of the procedure is measured. The procedure occurs approximately 24 hours after enrollment.

    Minutes, from the time of the start of the procedure (speculum insertion) to the conclusion of the procedure (speculum removal)

Secondary outcomes

  1. Assessment of Ease of Procedure by Operator

    Time frame: It is administered shortly after the primary outcome, which is one day after enrollment. The study is complete at that point.

    The operator for each procedure rated the ease of procedure on a categorical scale. The categories were collapsed into two: "easy or very easy" and "average or difficult".

  2. Moderate or Severe Pain Overnight

    Time frame: Overnight

    Women wer asked to rank their amount of pain on a catergorical scale. The outcome measure is the number of women experiencing moderate or severe pain overnight (after mifepristone or osmotic dilators, and before the abortions procedure)

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • Society of Family Planning

Registry information

Official study title

Mifepristone vs. Laminaria Insertion for Cervical Preparation Prior to Surgical Abortion at 14-16 Weeks

Acronym: SAMi

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 30, 2009
Registry last updated
Jan 31, 2014

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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