Misoprostol in Termination of First Trimester Missed Abortion
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Purpose
| Condition | Intervention |
|---|---|
| Miscarriage | Drug: Misoprostol ( Cytotec) 200 microgram a tablet |
| Study Type: | Interventional |
| Study Design: | 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 |
- 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 ]
- Higher patient satisfaction for self administered oral misoprostol at home [ Time Frame: 6 months ]
| Enrollment: | 100 |
| Study Start Date: | January 2008 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
|
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:
|
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.
Eligibility
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| Ages Eligible for Study: | 20 Years to 35 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
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
| Iraq | |
| Maternity Teaching Hospital | |
| Erbil, Hawler, Iraq, 964 | |
More Information
| Responsible Party: | Scientific Committe, Hawler Medical University |
| ClinicalTrials.gov Identifier: | NCT00797693 History of Changes |
| Other Study ID Numbers: |
324/2 |
| First Submitted: | November 21, 2008 |
| First Posted: | November 25, 2008 |
| 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:
|
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 |