Misoprostol for Cervical Priming Prior to Vacuum Aspiration

Phase 2

Completed

• Conditions: First Trimester Pregnancy; Surgical Termination of Pregnancy
• Interventions: Drug: Misoprostol sublingual, 1h; Drug: Misoprostol sublingual, 3h; Drug: Misoprostol vaginal, 3h; Drug: Placebo sublingual,1h; Drug: Placebo vaginal, 1h; Drug: Misoprostol vaginal, 1h; Drug: Placebo vaginal, 3h; Drug: Placebo sublingual, 3h

• Registration Number: NCT01933360
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-25
• Study First Submitted QC: 2013-08-28
• Study First Posted: 2013-09-02
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-13
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 184

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Misoprostol sublingual,1h	Misoprostol sublingual, 1h	Administration of misoprostol sublingually 1h prior to surgery
Misoprostol sublingual. 3h	Misoprostol sublingual, 3h	Administration of misoprostol sublingually 3h prior to surgery
Misoprostol vaginal,3h	Misoprostol vaginal, 3h	Administration of misoprostol vaginally 3h prior to surgery
Misoprostol vaginal,1h	Placebo sublingual,1h	Administration of misoprostol vaginally 1h prior to surgery
Misoprostol sublingual,1h	Placebo vaginal, 1h	Administration of misoprostol sublingually 1h prior to surgery
Misoprostol vaginal,1h	Misoprostol vaginal, 1h	Administration of misoprostol vaginally 1h prior to surgery
Misoprostol sublingual. 3h	Placebo vaginal, 3h	Administration of misoprostol sublingually 3h prior to surgery
Misoprostol vaginal,3h	Placebo sublingual, 3h	Administration of misoprostol vaginally 3h prior to surgery

Primary Outcome Measures

Name	Time	Method
Force needed for cervical dilatation	Measured at surgery	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

Secondary Outcome Measures

Name	Time	Method
Cervical diameter	Measured at surgery	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
Number of Participants with Adverse Events	Up to surgery	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

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden