Misoprostol for Cervical Priming Prior to Vacuum Aspiration

First Trimester Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01933360
• Other study ID #: W500M
• Status: Completed
• Phase: Phase 2
• First received: August 25, 2013
• Last updated: August 13, 2014
• Start date: August 2013
• Est. completion date: March 2014

Study information

• Verified date: August 2014
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• First Trimester Pregnancy
• Surgical Termination of Pregnancy

Intervention

Drug:
• Misoprostol sublingual, 1h
Misoprostol is administered sublingually 1 hour prior to surgical termination of early pregnancy
• Placebo sublingual,1h
Placebo for misoprostol is administered sublingually 1 hour prior to surgical termination of early pregnancy
• Misoprostol sublingual, 3h
Misoprostol is administered sublingually, 3 hours prior to surgical termination of early pregnancy
• Misoprostol vaginal, 1h
Misoprostol is administered vaginally 1 hour prior to surgical termination of early pregnancy
• Misoprostol vaginal, 3h
Misoprostol is administered vaginally 3 hours prior to surgical termination of early pregnancy
• Placebo sublingual, 3h
Placebo for misoprostol is administered sublingually 3 hours prior to surgical termination of early pregnancy
• Placebo vaginal, 1h
Placebo for misoprostol is administered vaginally 1 hour prior to surgical termination of early pregnancy
• Placebo vaginal, 3h
Placebo for misoprostol is administered vaginally 3 hours prior to surgical termination of early pregnancy

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	Yes