Buccal Versus Vaginal Misoprostol in Surgical Termination of the First Trimester Missed Abortion in Erbil

Hawler Medical University

Status and phase: Completed; Phase 2

Conditions: Missed Abortion

Treatments: Drug: Misoprostol (given buccally); Drug: Misoprostol (given vaginally)

Study type: Interventional

Funder types: Other

Identifiers

NCT00892229

IMS - 1769

Details and patient eligibility

About

The purpose of this study is to determine the effectiveness of buccal misoprostol and comparing this with vaginal route of the same drug.

Enrollment: 100 patients

Sex: Female

Ages: 19 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• first trimester missed abortion

Exclusion criteria

• history or evidence of disorders that represent contraindication to the use of misoprostol:

  • severe pulmonary diseases
  • congenital or acquired heart diseases
  • glaucoma
  • prolonged use of corticosteroid
  • sickle cell anemia and adrenal insufficiency
  • smokers
  • known hypersensitivity to drugs
  • any evidence of infection

• patient's refusal to participate in the study

• patients with abnormal results of investigations

• patients with previous operations on cervix like conisation, cauterization, previous dilatation and curettage

• patients with complete abortion

• patients with severe bleeding that required emergency surgical evacuation of the uterus

• patients with partially dissolved tablets at the site of application in both groups

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Buccal Misoprostol

Active Comparator group

Description:

Group one: 50 patients with first trimester missed abortion received buccal misoprostol

Treatment:

Drug: Misoprostol (given buccally)

Vaginal Misoprostol

Active Comparator group

Description:

Group two: 5 patients received vaginal misoprostol

Treatment:

Drug: Misoprostol (given vaginally)

Buccal and Vaginal Misoprostol

Active Comparator group

Description:

50 primiparous and 50 multiparous women: one hundred patients have been administered the medication buccally (25 primigravida and 25 multigravida), and vaginally (25 primigravida and 25 multigravida), three hours before dilation and curettage. They were admitted to the hospital one day before the surgical evacuation, and preparation of cross matched blood done for all recruited subjects. Each group was randomly allocated (1,3,5,... for the buccal group \& 2,4,6,... for the vaginal group) to receive 400 microgram misoprostol.

Treatment:

Drug: Misoprostol (given vaginally)

Drug: Misoprostol (given buccally)