Contact information
Type
Scientific
Contact name
Dr Samir Hidar
ORCID ID
Contact details
Maternité de Sousse
CHU F Hached
Boulevard Med Karoui
Sousse
4000
Tunisia
+216 98404526
HIDAR.SAMIR@gnet.tn
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration.
Ethics approval(s)
Not provided at time of registration.
Study design
Randomised active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Obstetrics and gynaecology
Intervention
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)
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Isosorbide dinitrate (Risordan®), misoprostol
Primary outcome measure
Not provided at time of registration.
Secondary outcome measures
Not provided at time of registration.
Overall study start date
01/04/2002
Overall study end date
30/04/2003
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Sex
Female
Target number of participants
Added 24/08/09: 34 in Risordan® group (31 completed trial), 36 in control group (30 completed trial)
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/04/2002
Recruitment end date
30/04/2003
Locations
Countries of recruitment
Tunisia
Study participating centre
Maternité de Sousse
Sousse
4000
Tunisia
Sponsor information
Organisation
Farhat Hached University Teaching Hospital (Tunisia)
Sponsor details
Department of Obstetrics and Gynaecology
Boulevard M Karoui
Sousse
4000
Tunisia
+216 7322 9990
Sponsor type
Hospital/treatment centre
Website
http://www.chu-hached.rns.tn/en/index.htm
ROR
Funders
Funder type
Hospital/treatment centre
Funder name
No external funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2005 | Yes | No |