Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Outcome of modified Misgav Ladach (MML) method in first and second time caesarean deliveries: a non-randomised controlled single-centre trial
Acronym
Study hypothesis
Does modified Misgav Ladach (MML) method result in better outcomes in first time caesarean deliveries compared to second time caesarean deliveries?
Ethics approval
Istanbul Bakirkoy Maternity and Children's Hospital Ethical Committee, approved on 07/11/2008.
Study design
Non-randomised controlled single-centre trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
15/11/2008
Overall trial end date
15/02/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Term pregnancies >36 weeks of gestation
2. No age limit
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Approximately 200
Participant 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
Recruitment start date
15/11/2008
Recruitment end date
15/02/2009
Locations
Countries of recruitment
Turkey
Trial participating centre
Istanbul cad no:95
Istanbul
34750
Turkey
Sponsor information
Organisation
Istanbul Bakirkoy Maternity and Children's Hospital (Turkey)
Sponsor details
c/o Dr Ali Gedikbasi
Department of Obstetrics and Gynaecology
Istanbul cad no. 95
Bakirkoy
Istanbul
34750
Turkey
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Istanbul Bakirkoy Maternity and Children's Hospital, Department of Obstetrics and Gynaecology (Turkey)
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
Basic results (scientific)
Publication list