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Misoprostol in Termination of First Trimester Missed Abortion

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ClinicalTrials.gov Identifier: NCT00797693
Recruitment Status : Completed
First Posted : November 25, 2008
Last Update Posted : November 25, 2008
Sponsor:
Collaborator:
HAWLER Maternity Hospital
Information provided by:
Hawler Medical University

Study Description
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Brief Summary:
The purpose of this study is to determine whether oral versus vaginal misoprostol is effective in termination of first trimester missed abortion and to compare between two different routes.

Condition or disease Intervention/treatment Phase
Miscarriage Drug: Misoprostol ( Cytotec) 200 microgram a tablet Not Applicable

Detailed Description:

Objective: To compare the effectiveness of oral versus vaginal misoprostol prior to surgical termination of first trimester missed abortion as cervical priming agent , the difference of cervical dilatation immediately prior to operation , the duration of operation and side effects between two treatment groups.

Design: This study was conducted as randomised study.

Setting: Maternity Teaching Hospital in Hawler/ Kurdistan/ Iraq.

Population: Over a period of six months from the first of January to the thirtieth of June, 2008, one hundred women were included in this study. They were cases of first trimester abortion (6-12 weeks).

Method: Patients were randomly selected for the type of treatment they received. The first group (oral) were assigned to receive 400 micrograms of misoprostol orally as preoperative cervical priming agent, where as the second group (vaginal) were allocated to have treatment either with vaginal misoprostol to receive 400 micrograms vaginally.

Main outcome measure: Oral versus vaginal misoprostol as cervical ripening agent prior to termination of first trimester missed abortion.

Keywords: First trimester, missed abortion, misoprostol, cervical ripening, oral, vaginal.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oral Versus Vaginal Misoprostol as Cervical Ripening Agent Prior to Surgical Termination of First Trimester Missed Abortions in Hawler Maternity Teaching Hospital in Erbil/Iraq
Study Start Date : January 2008
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

Arms and Interventions
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Arm Intervention/treatment
Experimental: Vaginal Misoprostol
A drug is given vaginally and to compare this with an oral administration of the same drug to find it is effect on it is effect on the cervix
 Drug: Misoprostol ( Cytotec) 200 microgram a tablet
In this study, two arms we put under study ... and to find how far a single drug, Misoprostol, is effective to have changes on the cervix.
Other Names:
  • PHARMACIA CORPORATION - Istanbul, serial number 022-00
  • 200 microgram a tablet
Experimental: Oral Misoprostol
A drug is given vaginally and to compare this with an oral administration of the same drug to find it is effect on it is effect on the cervix
 Drug: Misoprostol ( Cytotec) 200 microgram a tablet
In this study, two arms we put under study ... and to find how far a single drug, Misoprostol, is effective to have changes on the cervix.
Other Names:
  • PHARMACIA CORPORATION - Istanbul, serial number 022-00
  • 200 microgram a tablet


Outcome Measures
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Primary Outcome Measures :
  1. Priming with misoprostol administered orally or vaginally three hours before surgical termination of first trimester missed abortion under general anesthesia facilitates cervical dilatation [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Higher patient satisfaction for self administered oral misoprostol at home [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients were cases of first trimester missed abortion.
  • They have uneventful history apart from history of slight vaginal bleeding, with normal general examination. Gynecological examination revealed no vaginal bleeding or discharge with no dilatation of the internal os with enlarged uterus.

Exclusion Criteria:

  • Cases with suspected or proven ectopic pregnancy, history of Caesarean section, medical diseases, a known hypersensitivity to a drug, smokers, patients with abnormal results of investigation and the presence of vaginal bleeding were excluded from the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00797693


Locations
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Iraq
Maternity Teaching Hospital
Erbil, Hawler, Iraq, 964
Sponsors and Collaborators
Hawler Medical University
HAWLER Maternity Hospital
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Scientific Committe, Hawler Medical University
ClinicalTrials.gov Identifier: NCT00797693    
Other Study ID Numbers: 324/2
First Posted: November 25, 2008    Key Record Dates
Last Update Posted: November 25, 2008
Last Verified: November 2008
Keywords provided by Hawler Medical University:
First trimester
missed abortion
misoprostol
cervical ripening
 oral
vaginal
first trimester missed abortion
Additional relevant MeSH terms:
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Abortion, Spontaneous
Abortion, Missed
Pregnancy Complications
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
 Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics