Misoprostol for Cervical Priming Prior to Vacuum Aspiration

Study Overview
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Brief Summary
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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.

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

Conditions
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First Trimester Pregnancy, Surgical Termination of Pregnancy

Intervention / Treatment
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* Drug: Misoprostol sublingual, 1h
* Drug: Placebo sublingual,1h
* Drug: Misoprostol sublingual, 3h
* Drug: Misoprostol vaginal, 1h
* Drug: Misoprostol vaginal, 3h
* Drug: Placebo sublingual, 3h
* Drug: Placebo vaginal, 1h
* Drug: Placebo vaginal, 3h


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Misoprostol, First trimester pregnancy, Surgical abortion, Cervical priming