Blunt versus sharp expansion of the uterine incision at Caesarean delivery: a prospective randomised clinical trial

ISRCTN ISRCTN34712244
DOI https://doi.org/10.1186/ISRCTN34712244
Secondary identifying numbers N/A
Submission date
26/02/2004
Registration date
30/03/2004
Last edited
26/08/2009
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

71, rue Ch Kallala
Sousse
4011
Tunisia

Phone +216 98 40 45 26
Email hidar.samir@gnet.tn

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymHYDICI
Study objectivesNot provided at time of registration

Please note that the target number of participants was added as of 26/08/2009.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedObstetrics and gynaecology
InterventionThe 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 typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2000
Completion date31/12/2001

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants300
Key inclusion criteriaAll 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
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/2000
Date of final enrolment31/12/2001

Locations

Countries of recruitment

  • Tunisia

Study participating centre

71, rue Ch Kallala
Sousse
4011
Tunisia

Sponsor information

Farhat Hached University Teaching Hospital (Tunisia)
University/education

Department of Obstetrics and Gynaecology
Farhat Hached University Teaching Hospital
Boulevard M. Karoui
Sousse
4000
Tunisia

ROR logo "ROR" https://ror.org/0059hys23

Funders

Funder type

Hospital/treatment centre

Added as of 26/08/2009:

No information available

Farhat Hached University Teaching Hospital (Tunisia)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/04/2007 Yes No