Condition category
Pregnancy and Childbirth
Date applied
18/03/2009
Date assigned
20/04/2009
Last edited
21/04/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mehmet Murat Naki

ORCID ID

Contact details

Cihat Saran Sk. Cagdas Apt. No:11/3
Kucukyali Maltepe
Istanbul
34841
Turkey
mmuratnaki@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Comparative study of modified Misgav-Ladach and Pfannenstiel-Kerr caesarean techniques: a randomised controlled trial

Acronym

Study hypothesis

Does modified Misgav-Ladach (MML) method result in better outcomes in first time caesarean deliveries compared to Pfannenstiel-Kerr method?

Ethics approval

Ethics Committee of the Dr. Lutfi Kirdar Kartal Research and Training Hospital approved on the 26th March 2009 (ref: 8/26.03.2009)

Study design

Randomised controlled single centre trial

Primary study design

Interventional

Secondary study design

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 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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

26/03/2009

Overall trial end date

26/09/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Pregnancies greater than 34 weeks of gestation
2. Women between ages of 18 - 45 years
3. First time caesarean section

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Approximately 180

Participant 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

Recruitment start date

26/03/2009

Recruitment end date

26/09/2009

Locations

Countries of recruitment

Turkey

Trial participating centre

Cihat Saran Sk. Cagdas Apt. No:11/3
Istanbul
34841
Turkey

Sponsor information

Organisation

Dr. Lutfi Kirdar Kartal Research and Training Hospital (Turkey)

Sponsor details

c/o M. Murat Naki
Department of Obstetrics and Gynaecology
Istanbul
34000
Turkey

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Dr. Lutfi Kirdar Kartal Research and Training Hospital (Turkey) - Department of Obstetrics and Gynaecology

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes