Misoprostol for Cervical Priming Prior to Vacuum Aspiration

Phase 2CompletedNCT01933360

Karolinska Institutet184 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

184

Conditions

First Trimester Pregnancy Surgical Termination of Pregnancy

Interventions

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

Placebo sublingual,1hDRUG

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

Misoprostol sublingual, 3hDRUG

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

Misoprostol vaginal, 1hDRUG

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

Misoprostol vaginal, 3hDRUG

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

Placebo sublingual, 3hDRUG

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

Placebo vaginal, 1hDRUG

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

Placebo vaginal, 3hDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Karolinska University Hospital

Stockholm, Sweden

Outcomes

Primary Outcomes

Force needed for cervical dilatation

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

Time frame: Measured at surgery

Secondary Outcomes

Cervical diameter

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

Time frame: Measured at surgery

Number of Participants with Adverse Events

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

Time frame: Up to surgery

Data from ClinicalTrials.gov

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