Misoprostol for Cervical Priming Prior to Vacuum Aspiration

NCT ID: NCT01933360

Last Updated: 2014-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-03-31

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.

Conditions

First Trimester Pregnancy; Surgical Termination of Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Misoprostol sublingual,1h

Administration of misoprostol sublingually 1h prior to surgery

Group Type: ACTIVE_COMPARATOR

Misoprostol sublingual, 1h

Intervention Type: DRUG

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

Placebo vaginal, 1h

Intervention Type: DRUG

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

Misoprostol sublingual. 3h

Administration of misoprostol sublingually 3h prior to surgery

Group Type: ACTIVE_COMPARATOR

Misoprostol sublingual, 3h

Intervention Type: DRUG

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

Placebo vaginal, 3h

Intervention Type: DRUG

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

Misoprostol vaginal,1h

Administration of misoprostol vaginally 1h prior to surgery

Group Type: ACTIVE_COMPARATOR

Placebo sublingual,1h

Intervention Type: DRUG

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

Misoprostol vaginal, 1h

Intervention Type: DRUG

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

Misoprostol vaginal,3h

Administration of misoprostol vaginally 3h prior to surgery

Group Type: ACTIVE_COMPARATOR

Misoprostol vaginal, 3h

Intervention Type: DRUG

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

Placebo sublingual, 3h

Intervention Type: DRUG

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

Interventions

Misoprostol sublingual, 1h

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

Intervention Type: DRUG

Placebo sublingual,1h

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

Intervention Type: DRUG

Misoprostol sublingual, 3h

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

Intervention Type: DRUG

Misoprostol vaginal, 1h

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

Intervention Type: DRUG

Misoprostol vaginal, 3h

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

Intervention Type: DRUG

Placebo sublingual, 3h

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

Intervention Type: DRUG

Placebo vaginal, 1h

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

Intervention Type: DRUG

Placebo vaginal, 3h

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

Intervention Type: DRUG

Other Intervention Names

Misoprostol (Cytotec)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Kristina Gemzell Danielsson

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristina Gemzell Danielsson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Karolinska University Hospital

Stockholm, , Sweden

Countries

Sweden

References

Saav I, Kopp Kallner H, Fiala C, Gemzell-Danielsson K. Sublingual versus vaginal misoprostol for cervical dilatation 1 or 3 h prior to surgical abortion: a double-blinded RCT. Hum Reprod. 2015 Jun;30(6):1314-22. doi: 10.1093/humrep/dev071. Epub 2015 Apr 2.

Reference Type: DERIVED

PMID: 25840429 (View on PubMed)

Other Identifiers

W500M

Identifier Type: -

Identifier Source: org_study_id