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Misoprostol for Cervical Priming Prior to Vacuum Aspiration

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Karolinska Institute

Status and phase

Completed
Phase 2

Conditions

Surgical Termination of Pregnancy
First Trimester Pregnancy

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

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

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: Placebo sublingual,1h
Drug: Misoprostol vaginal, 1h
Misoprostol vaginal,3h
Active Comparator group
Description:
Administration of misoprostol vaginally 3h prior to surgery
Treatment:
Drug: Misoprostol vaginal, 3h
Drug: Placebo sublingual, 3h

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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