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
Protocol serial number	N/A
Sponsor	Farhat Hached University Teaching Hospital (Tunisia)
Funder	No external funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Samir Hidar
Scientific

Maternité de Sousse
CHU F Hached
Boulevard Med Karoui
Sousse
4000
Tunisia

Phone	+216 98404526
Email	HIDAR.SAMIR@gnet.tn

Primary study design	Interventional
Study design	Randomised active controlled parallel group trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Isosorbide dinitrate (Risordan®), misoprostol
Primary outcome measure(s)	Not provided at time of registration.
Key secondary outcome measure(s)	Not provided at time of registration.
Completion date	30/04/2003

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	70
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

Maternité de Sousse

Sousse
4000
Tunisia

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2005		Yes	No