Condition category
Pregnancy and Childbirth
Date applied
16/12/2002
Date assigned
16/12/2002
Last edited
24/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration.

Ethics approval

Not provided at time of registration.

Study design

Randomised active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial 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

Phase

Not Specified

Drug names

Isosorbide dinitrate (Risordan®), misoprostol

Primary outcome measures

Not provided at time of registration.

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

01/04/2002

Overall trial end date

30/04/2003

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16041629

Publication citations

  1. Results

    Hidar S, Bouddebous M, Chaïeb A, Jerbi M, Bibi M, Khaïri H, Randomized controlled trial of vaginal misoprostol versus vaginal misoprostol and isosorbide dinitrate for termination of pregnancy at 13-29 weeks., Arch. Gynecol. Obstet., 2005, 273, 3, 157-160, doi: 10.1007/s00404-005-0053-7.

Additional files

Editorial Notes