Misoprostol for Cervical Priming Prior to Vacuum Aspiration

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

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 Overview

• Status: Completed
• Conditions: First Trimester Pregnancy; Surgical Termination of Pregnancy
• Intervention / Treatment: Drug: Misoprostol sublingual, 1h; Drug: Placebo vaginal, 1h; Drug: Misoprostol sublingual, 3h; Drug: Placebo vaginal, 3h; Drug: Placebo sublingual,1h; Drug: Misoprostol vaginal, 1h; Drug: Misoprostol vaginal, 3h; Drug: Placebo sublingual, 3h

• Study Type: Interventional
• Enrollment (Actual): 184
• Phase: Phase 2

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 17176
    • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Misoprostol sublingual,1h; Administration of misoprostol sublingually 1h prior to surgery	Drug: Misoprostol sublingual, 1h; Misoprostol is administered sublingually 1 hour prior to surgical termination of early pregnancy; Other Names: Misoprostol (Cytotec); Drug: Placebo vaginal, 1h; Placebo for misoprostol is administered vaginally 1 hour prior to surgical termination of early pregnancy
Active Comparator: Misoprostol sublingual. 3h; Administration of misoprostol sublingually 3h prior to surgery	Drug: Misoprostol sublingual, 3h; Misoprostol is administered sublingually, 3 hours 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
Active Comparator: Misoprostol vaginal,1h; Administration of misoprostol vaginally 1h prior to surgery	Drug: Placebo sublingual,1h; Placebo for misoprostol is administered sublingually 1 hour prior to surgical termination of early pregnancy; Drug: Misoprostol vaginal, 1h; Misoprostol is administered vaginally 1 hour prior to surgical termination of early pregnancy
Active Comparator: Misoprostol vaginal,3h; Administration of misoprostol vaginally 3h prior to surgery	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Up to surgery

Collaborators and Investigators

• Sponsor: Karolinska Institutet

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: August 25, 2013
• First Submitted That Met QC Criteria: August 28, 2013
• First Posted (Estimate): September 2, 2013

Study Record Updates

• Last Update Posted (Estimate): August 15, 2014
• Last Update Submitted That Met QC Criteria: August 13, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Misoprostol; Surgical abortion; First trimester pregnancy; Cervical priming
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: W500M