Comparative study of modified Misgav-Ladach and Pfannenstiel-Kerr caesarean techniques
| ISRCTN | ISRCTN96000549 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96000549 |
| Secondary identifying numbers | N/A |
- Submission date
- 18/03/2009
- Registration date
- 20/04/2009
- Last edited
- 21/04/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Mehmet Murat Naki
Scientific
Scientific
Cihat Saran Sk. Cagdas Apt. No:11/3
Kucukyali Maltepe
Istanbul
34841
Türkiye
| mmuratnaki@yahoo.com |
Study information
| Study design | Randomised controlled single centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Comparative study of modified Misgav-Ladach and Pfannenstiel-Kerr caesarean techniques: a randomised controlled trial |
| Study objectives | Does modified Misgav-Ladach (MML) method result in better outcomes in first time caesarean deliveries compared to Pfannenstiel-Kerr method? |
| Ethics approval(s) | Ethics Committee of the Dr. Lutfi Kirdar Kartal Research and Training Hospital approved on the 26th March 2009 (ref: 8/26.03.2009) |
| Health condition(s) or problem(s) studied | Caesarean deliveries |
| Intervention | This trial is taking place at the Istanbul Dr. Lutfi Kirdar Kartal Research and Training Hospital, Department of Obstetrics and Gynaecology. Approximately 180 patients will be recruited, 90 patients in each of the following two groups: Group 1: Caesarean delivery with the Pfannenstiel-Kerr method Group 2: Caesarean delivery with the MML method Patient allocation will be carried out as follows: A computer based randomisation will be prepared. The operation type will be printed on identical sheets of paper, which will be put into identical, consecutively numbered sealed opaque envelopes by a non-participating colleague. |
| Intervention type | Other |
| Primary outcome measure | 1. Operation time 2. Time until delivery of neonate 3. APGAR score 4. Blood loss 5. Operative complications 6. Number of used sutures All measured intra-operatively. |
| Secondary outcome measures | 1. Length of hospital stay 2. Wound seroma 3. Wound infection 4. Mobilisation time 5. Visual Analogue Scale score at 6 and 24 hours of the operation 6. Time of bowel restitution Measured post-operatively at 6 hours, 24 hours and 5 days. |
| Overall study start date | 26/03/2009 |
| Completion date | 26/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | Approximately 180 |
| Key inclusion criteria | 1. Pregnancies greater than 34 weeks of gestation 2. Women between ages of 18 - 45 years 3. First time caesarean section |
| Key exclusion criteria | 1. Previous lower abdominal incision 2. Pregnancies less than 34 weeks of gestation 3. Known severe anaemia 4. Bleeding disorders 5. Intrapartum febrile illness |
| Date of first enrolment | 26/03/2009 |
| Date of final enrolment | 26/09/2009 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
Cihat Saran Sk. Cagdas Apt. No:11/3
Istanbul
34841
Türkiye
34841
Türkiye
Sponsor information
Dr. Lutfi Kirdar Kartal Research and Training Hospital (Turkey)
Hospital/treatment centre
Hospital/treatment centre
c/o M. Murat Naki
Department of Obstetrics and Gynaecology
Istanbul
34000
Türkiye
"ROR" |
https://ror.org/01c2wzp81 |
|---|
Funders
Funder type
Hospital/treatment centre
Dr. Lutfi Kirdar Kartal Research and Training Hospital (Turkey) - Department of Obstetrics and Gynaecology
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
