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Completed

NCT Number: NCT01933360

Misoprostol for Cervical Priming Prior to Vacuum Aspiration

Despite of the widespread use, and extensive studies, the optimal route of administration of misoprostol before surgical abortion remains to be defined. Following administration of 400 mcg vaginally as per clinical guidelines, the time for optimal priming seems to be 3 hours, but the longer the interval the greater the risk or bleeding and expulsion of the uterine contents before the surgical evacuation. Sublingual administration seems to give adequate plasma concentration and cervical priming faster than oral or vaginal administration. This may allow a shorter waiting time with maintained efficacy, less side effects and logistic advantages.

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Key information

Conditions

First Trimester Pregnancy Surgical Termination of Pregnancy

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Karolinska University Hospital

Stockholm, 17176, Sweden

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • women opting for first trimester surgical abortion
  • nulliparous
  • able and willing to provide informed consent

Exclusion criteria

  • unwilling to participate,
  • unable to communicate in Swedish and English and
  • minors (i.e. women < 18 years of age),
  • contraindications to misoprostol
  • women with pathological pregnancies

Treatment and study plan

Misoprostol sublingual, 1h

Drug

Misoprostol is administered sublingually 1 hour prior to surgical termination of early pregnancy

Other names: Misoprostol (Cytotec)

Placebo sublingual,1h

Drug

Placebo for misoprostol is administered sublingually 1 hour prior to surgical termination of early pregnancy

Misoprostol sublingual, 3h

Drug

Misoprostol is administered sublingually, 3 hours prior to surgical termination of early pregnancy

Misoprostol vaginal, 1h

Drug

Misoprostol is administered vaginally 1 hour prior to surgical termination of early pregnancy

Misoprostol vaginal, 3h

Drug

Misoprostol is administered vaginally 3 hours prior to surgical termination of early pregnancy

Placebo sublingual, 3h

Drug

Placebo for misoprostol is administered sublingually 3 hours prior to surgical termination of early pregnancy

Placebo vaginal, 1h

Drug

Placebo for misoprostol is administered vaginally 1 hour prior to surgical termination of early pregnancy

Placebo vaginal, 3h

Drug

Placebo for misoprostol is administered vaginally 3 hours prior to surgical termination of early pregnancy

Primary outcomes

  1. Force needed for cervical dilatation

    Time frame: Measured at surgery

    Cervical dilation is evaluated at surgery using Hulka dilators connected to a tonometer. Force and time needed for the dilatation is recorded by the tonometer

Secondary outcomes

  1. Cervical diameter

    Time frame: Measured at surgery

    Cervical dilation is evaluated at surgery using Hulka dilators connected to a tonometer.The largest dilator that can pass through the inner cervical os without any resistance corresponds to the presurgical cervical diameter

  2. Number of Participants with Adverse Events

    Time frame: Up to surgery

    Any side effects or symptoms such as nausea, vomiting, uterine cramps, expulsion, bleeding, rash, chills, blood pressure etc are recorded continuously from misoprostol administration until to surgery

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Sublingual Versus Vaginal Misoprostol for Cervical Dilatation 1 or 3 Hours Prior to Surgical Abortion

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 2, 2013
Registry last updated
Aug 15, 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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