Misoprostol for Cervical Priming Prior to Vacuum Aspiration

Karolinska Institute

Status and phase: Completed; Phase 2

Conditions: Surgical Termination of Pregnancy; First Trimester Pregnancy

Treatments: Drug: Misoprostol sublingual, 1h; Drug: Misoprostol vaginal, 3h; Drug: Placebo vaginal, 3h; Drug: Placebo vaginal, 1h; Drug: Misoprostol sublingual, 3h; Drug: Placebo sublingual,1h; Drug: Placebo sublingual, 3h; Drug: Misoprostol vaginal, 1h

Study type: Interventional

Funder types: Other

Identifiers

NCT01933360

W500M

Details and patient eligibility

About

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.

Enrollment: 184 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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184 participants in 4 patient groups

Misoprostol sublingual,1h

Active Comparator group

Description:

Administration of misoprostol sublingually 1h prior to surgery

Treatment:

Drug: Placebo vaginal, 1h

Drug: Misoprostol sublingual, 1h

Misoprostol sublingual. 3h

Active Comparator group

Description:

Administration of misoprostol sublingually 3h prior to surgery

Treatment:

Drug: Misoprostol sublingual, 3h

Drug: Placebo vaginal, 3h

Misoprostol vaginal,1h

Active Comparator group

Description:

Administration of misoprostol vaginally 1h prior to surgery

Treatment:

Drug: Misoprostol vaginal, 1h

Drug: Placebo sublingual,1h

Misoprostol vaginal,3h

Active Comparator group

Description:

Administration of misoprostol vaginally 3h prior to surgery

Treatment:

Drug: Placebo sublingual, 3h

Drug: Misoprostol vaginal, 3h