Comparative study of modified Misgav-Ladach and Pfannenstiel-Kerr caesarean techniques

ISRCTN	ISRCTN96000549
DOI	https://doi.org/10.1186/ISRCTN96000549
Protocol serial number	N/A
Sponsor	Dr. Lutfi Kirdar Kartal Research and Training Hospital (Turkey)
Funder	Dr. Lutfi Kirdar Kartal Research and Training Hospital (Turkey) - Department of Obstetrics and Gynaecology

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

Cihat Saran Sk. Cagdas Apt. No:11/3
Kucukyali Maltepe
Istanbul
34841
Türkiye

Email	mmuratnaki@yahoo.com

Study information

Primary study design	Interventional
Study design	Randomised controlled single centre trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	26/09/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	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

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?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes