Outcome of modified Misgav Ladach (MML) method in first and second time caesarean deliveries
| ISRCTN | ISRCTN26532492 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26532492 |
| Secondary identifying numbers | N/A |
- Submission date
- 31/01/2009
- Registration date
- 19/02/2009
- Last edited
- 20/02/2009
- 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 Ali Gedikbasi
Scientific
Scientific
Istanbul cad no:95
Bakyrkoy
Istanbul Bakirkoy Maternity and Children's Hospital
Department of Obstetrics and Gynaecology
Istanbul
34750
Türkiye
Study information
| Study design | Non-randomised controlled single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non 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 | Outcome of modified Misgav Ladach (MML) method in first and second time caesarean deliveries: a non-randomised controlled single-centre trial |
| Study objectives | Does modified Misgav Ladach (MML) method result in better outcomes in first time caesarean deliveries compared to second time caesarean deliveries? |
| Ethics approval(s) | Istanbul Bakirkoy Maternity and Children's Hospital Ethical Committee, approved on 07/11/2008. |
| Health condition(s) or problem(s) studied | Caesarean deliveries |
| Intervention | This trial is taking place at the Istanbul Bakirkoy Maternity and Children's Hospital, Department of Obstetrics and Gynaecology. Approximately 200 patients will be recruited, 50 patients in each of the following four groups: Patients who have never had a caesarean operation: Group 1: Caesarean delivery with the Pfannenstiel method Group 2: Caesarean delivery with the MML method Patients who have had a caesarean operation in previous pregnancy: Group 3: Caesarean delivery with the Pfannenstiel method Group 4: Caesarean delivery with the MML method Patient allocation will be carried out as follows: On Mondays: Patients planned for first time caesarean delivery will be operated with the MML method. On Tuesdays: Patients planed for first time caesarean delivery will be operated by the Pfannenstiel method. Patients planned for second time caesarean delivery will be operated by the MML method. On Fridays: Patients planned for second caesarean deliveries will be operated by the Pfannenstiel method. Total duration of follow-up: 4 weeks after operation |
| Intervention type | Other |
| Primary outcome measure | Surgical outcomes: 1. Operation time 2. Time until delivery of neonate 3. APGAR score 4. Haemoglobin 5. Haematocrit 6. Surgical complications |
| Secondary outcome measures | Post-operative outcomes: 1. Hospital stay 2. Febrile morbidity 3. Scar complications 4. Infection 5. Post-operative recovery Secondary outcomes 2 to 5 were assessed 2 and 7 days after caesarean operation. However, patients who experienced any problem were followed-up until resolution of the problem. |
| Overall study start date | 15/11/2008 |
| Completion date | 15/02/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Approximately 200 |
| Key inclusion criteria | 1. Term pregnancies >36 weeks of gestation 2. No age limit |
| Key exclusion criteria | 1. Intrauterine infection 2. Anaemia (<haematocrit [Htc] %28) 3. Preoperative transfusion 4. Maternal urinary infection 5. Maternal fever (>37.5 Celsius) 6. Use of antibiotics in the last 7 days 7. Placenta previa 8. Abruptio placenta 9. Severe preeclampsi and Hellp syndrome |
| Date of first enrolment | 15/11/2008 |
| Date of final enrolment | 15/02/2009 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
Istanbul cad no:95
Istanbul
34750
Türkiye
34750
Türkiye
Sponsor information
Istanbul Bakirkoy Maternity and Children's Hospital (Turkey)
Hospital/treatment centre
Hospital/treatment centre
c/o Dr Ali Gedikbasi
Department of Obstetrics and Gynaecology
Istanbul cad no. 95
Bakirkoy
Istanbul
34750
Türkiye
| Website | http://www.bakirkoydogumevi.gov.tr |
|---|
Funders
Funder type
Hospital/treatment centre
Istanbul Bakirkoy Maternity and Children's Hospital, Department of Obstetrics and Gynaecology (Turkey)
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 |
