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 |
| Protocol serial number | N/A |
| Sponsor | Farhat Hached University Teaching Hospital (Tunisia) |
| Funders | Added as of 26/08/2009:, Farhat Hached University Teaching Hospital (Tunisia) |
- 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
Scientific
71, rue Ch Kallala
Sousse
4011
Tunisia
| Phone | +216 98 40 45 26 |
|---|---|
| hidar.samir@gnet.tn |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | HYDICI |
| Study objectives | Not 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) studied | 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 |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 300 |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 31/12/2001 |
Locations
Countries of recruitment
- Tunisia
Study participating centre
71, rue Ch Kallala
Sousse
4011
Tunisia
4011
Tunisia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/04/2007 | Yes | No |
