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
| ISRCTN | ISRCTN44341343 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44341343 |
| Secondary identifying numbers | N/A |
- Submission date
- 16/12/2002
- Registration date
- 16/12/2002
- Last edited
- 24/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Samir Hidar
Scientific
Scientific
Maternité de Sousse
CHU F Hached
Boulevard Med Karoui
Sousse
4000
Tunisia
| Phone | +216 98404526 |
|---|---|
| HIDAR.SAMIR@gnet.tn |
Study information
| 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 |
| Scientific title | |
| Study objectives | Not provided at time of registration. |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 30/04/2003 |
Eligibility
| 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) |
| Key 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 |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/04/2002 |
| Date of final enrolment | 30/04/2003 |
Locations
Countries of recruitment
- Tunisia
Study participating centre
Maternité de Sousse
Sousse
4000
Tunisia
4000
Tunisia
Sponsor information
Farhat Hached University Teaching Hospital (Tunisia)
Hospital/treatment centre
Hospital/treatment centre
Department of Obstetrics and Gynaecology
Boulevard M Karoui
Sousse
4000
Tunisia
| Phone | +216 7322 9990 |
|---|---|
| Website | http://www.chu-hached.rns.tn/en/index.htm |
"ROR" |
https://ror.org/0059hys23 |
Funders
Funder type
Hospital/treatment centre
No external funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2005 | Yes | No |
