Contact information
Type
Scientific
Primary contact
Dr Samir Hidar
ORCID ID
Contact details
71
rue Ch Kallala
Sousse
4011
Tunisia
+216 98 40 45 26
hidar.samir@gnet.tn
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
HYDICI
Study hypothesis
Not provided at time of registration
Please note that the target number of participants was added as of 26/08/2009.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled 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
The patients will be randomised in two groups:
1. Blunt expansion of an initial approximately 2 cm incision with obstetrician's fingers
2. Sharp expansion of an initial approximately 2 cm incision by cutting scissors
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2000
Overall trial end date
31/12/2001
Reason abandoned
Eligibility
Participant inclusion criteria
All patients requiring elective or emergency, primary or repeat Caesarean section and planned to have low segment transverse uterine incision with:
1. Gestational age >34 weeks
2. No multiple gestation
3. No placenta praevia
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
300
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2000
Recruitment end date
31/12/2001
Locations
Countries of recruitment
Tunisia
Trial participating centre
71, rue Ch Kallala
Sousse
4011
Tunisia
Funders
Funder type
Hospital/treatment centre
Funder name
Added as of 26/08/2009:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Farhat Hached University Teaching Hospital (Tunisia)
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
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17566395
Publication citations
-
Results
Hidar S, Jerbi M, Hafsa A, Slama A, Bibi M, Khaïri H, [The effect of uterine incision expansion at caesarean delivery on perioperative haemorrhage: a prospective randomised clinical trial]., Rev Med Liege, 2007, 62, 4, 235-238.