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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN44341343 |
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Date of registration:
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16/12/2002 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A comparison of vaginal misoprostol versus vaginal misoprostol and nitric oxide donor for termination of pregnancy at 13 to 29 weeks. A prospective randomised trial
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Scientific title:
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Date of first enrolment:
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01/04/2002 |
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Target sample size:
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70 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN44341343 |
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Study type:
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Interventional |
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Study design:
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Randomised active controlled parallel group trial (Treatment)
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Phase:
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Countries of recruitment
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Tunisia
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Samir
Hidar |
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Address:
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Maternité de Sousse
CHU F Hached
Boulevard Med Karoui
4000
Sousse
Tunisia |
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Telephone:
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+216 98404526 |
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Email:
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HIDAR.SAMIR@gnet.tn |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. All patients requiring a termination of pregnancy between 13 and 29 weeks of gestation
2. No pregnancy induced hypertension
3. No pre-eclampsia
4. No vaginal bleeding
5. Cervix dilated less then 2 cm
6. No vaginal bleeding
7. At admission blood pressure: systolic >120 mmHg; diastolic >80 mmHg
Exclusion criteria: Does not match inclusion criteria
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Obstetrics and gynaecology
Pregnancy and Childbirth
Medical abortion
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Intervention(s)
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After inclusion, patients will be randomised in two groups:
First Group (Risordan®): Misoprostol (200 µg) will be administered vaginally every 12 h. In addition, 20 mg isosorbide dinitrate Risordan® will be administered vaginally every 12 h.
Second Group (Controls): In this group, only misoprostol will be administered (200 µg every 12 h).
Principal participant variables:
1. Maternal age and parity
2. Gestational age
3. Induction to abortion interval
4. 48 h successful abortion rate
5. Mother satisfaction
6. Hospital stay (in hours)
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Primary Outcome(s)
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Not provided at time of registration.
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Secondary Outcome(s)
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Not provided at time of registration.
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Source(s) of Monetary Support
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No external funding
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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