Misoprostol for Cervical Priming Prior to Vacuum Aspiration

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.

Conditions

• First Trimester Pregnancy
• Surgical Termination of Pregnancy

Interventions

DRUG

Misoprostol sublingual, 1h

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

DRUG

Placebo sublingual,1h

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

DRUG

Misoprostol sublingual, 3h

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

DRUG

Misoprostol vaginal, 1h

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

DRUG

Misoprostol vaginal, 3h

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

DRUG

Placebo sublingual, 3h

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

DRUG

Placebo vaginal, 1h

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

DRUG

Placebo vaginal, 3h

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

Sponsors & Collaborators

• Karolinska Institutet

  lead OTHER

Principal Investigators

• Kristina Gemzell Danielsson, MD, PhD · Karolinska Institutet

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-08-31

Primary Completion

2014-03-31

Completion

2014-03-31

Countries

• Sweden

Study Locations