Misoprostol for Cervical Priming Prior to Vacuum Aspiration

NCT01933360 | Completed Phase 2 DMC

• 1 other identifier: W500M
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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

Keywords

Misoprostol; First trimester pregnancy; Surgical abortion; Cervical priming

Outcome Measures

Primary Outcomes (1)

• 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

  Measured at surgery

Secondary Outcomes (2)

• Cervical diameter

  Measured at surgery

• Number of Participants with Adverse Events

  Up to surgery

Study Arms (4)

Misoprostol sublingual,1h

ACTIVE COMPARATOR

Administration of misoprostol sublingually 1h prior to surgery

Drug: Misoprostol sublingual, 1h; Drug: Placebo vaginal, 1h

Misoprostol sublingual. 3h

ACTIVE COMPARATOR

Administration of misoprostol sublingually 3h prior to surgery

Drug: Misoprostol sublingual, 3h; Drug: Placebo vaginal, 3h

Misoprostol vaginal,1h

ACTIVE COMPARATOR

Administration of misoprostol vaginally 1h prior to surgery

Drug: Placebo sublingual,1h; Drug: Misoprostol vaginal, 1h

Misoprostol vaginal,3h

ACTIVE COMPARATOR

Administration of misoprostol vaginally 3h prior to surgery

Drug: Misoprostol vaginal, 3h; Drug: Placebo sublingual, 3h

Interventions

Misoprostol sublingual, 1h DRUG

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

Also known as: Misoprostol (Cytotec)

Misoprostol sublingual,1h

Placebo sublingual,1h DRUG

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

Misoprostol vaginal,1h

Misoprostol sublingual, 3h DRUG

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

Misoprostol sublingual. 3h

Misoprostol vaginal, 1h DRUG

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

Misoprostol vaginal,1h

Misoprostol vaginal, 3h DRUG

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

Misoprostol vaginal,3h

Placebo sublingual, 3h DRUG

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

Misoprostol vaginal,3h

Placebo vaginal, 1h DRUG

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

Misoprostol sublingual,1h

Placebo vaginal, 3h DRUG

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

Misoprostol sublingual. 3h

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Related Publications (1)

• 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.

  PMID: 25840429 DERIVED

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Kristina Gemzell Danielsson, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 25, 2013
• First Posted: September 2, 2013
• Study Start: August 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: August 15, 2014

Record last verified: 2014-08

Locations

SE (1)