Condition category
Pregnancy and Childbirth
Date applied
26/02/2004
Date assigned
30/03/2004
Last edited
26/08/2009
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

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

Sponsor information

Organisation

Farhat Hached University Teaching Hospital (Tunisia)

Sponsor details

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

Sponsor type

University/education

Website

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

  1. 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.

Additional files

Editorial Notes