Misoprostol for Cervical Priming Prior to Vacuum Aspiration

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01933360

Enrollment

184

Registered

2013-09-02

Start date

2013-08-31

Completion date

2014-03-31

Last updated

2014-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

First Trimester Pregnancy, Surgical Termination of Pregnancy

Keywords

Misoprostol, First trimester pregnancy, Surgical abortion, Cervical priming

Brief summary

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.

Interventions

DRUGMisoprostol sublingual, 1h

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

DRUGPlacebo sublingual,1h

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

DRUGMisoprostol sublingual, 3h

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

DRUGMisoprostol vaginal, 1h

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

DRUGMisoprostol vaginal, 3h

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

DRUGPlacebo sublingual, 3h

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

DRUGPlacebo vaginal, 1h

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

DRUGPlacebo vaginal, 3h

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Force needed for cervical dilatation	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

Measure	Time frame	Description
Cervical diameter	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
Number of Participants with Adverse Events	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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026