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Completed

NCT Number: NCT00892229

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

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

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Key information

Conditions

Missed Abortion Abortion, Missed Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

19 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Iraqi Medical Specialization

Risafa, Baghdad Governorate, 00964, Iraq

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol (given buccally)

Drug

400 microgram misoprostol given buccally three hours before dilation and curettage (PHARMACIA CORPORATION - Istanbul, serial number 022-00, a tablet contains 200 micrograms)

Other names: serial number 022-00

Misoprostol (given vaginally)

Drug

400 microgram misoprostol (MISOPROSTOL - PHARMACIA CORPORATION - Istanbul, serial number 022-00, a tablet contains 200 micrograms)

Other names: serial number 022-00

Primary outcomes

  1. To compare the efficacy of buccal administration to the more commonly vaginal route for preoperative cervical and priming in patients with first trimester surgical abortion. (Buccal Vs. Vaginal Misoprostol in the First Trimester Missed Abortion.)

    Time frame: March 2007 to March 2008

Secondary outcomes

  1. The secondary objectives are to compare the side effects and acceptability by the subjects.

    Time frame: March 2007 to March 2008

Sponsors and collaborators

Lead sponsor

Hawler Medical University

Other

Collaborators

  • NEGATIVE

Registry information

Official study title

Buccal Versus Vaginal Misoprostol for Cervical Ripening Prior to Surgical Termination of the First Trimester Missed Abortion in Erbil

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 4, 2009
Registry last updated
May 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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