Condition category
Pregnancy and Childbirth
Date applied
31/01/2009
Date assigned
19/02/2009
Last edited
20/02/2009
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 Ali Gedikbasi

ORCID ID

Contact details

Istanbul cad no:95
Bakyrkoy
Istanbul Bakirkoy Maternity and Children's Hospital
Department of Obstetrics and Gynaecology
Istanbul
34750
Turkey

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 measures

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

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

http://www.bakirkoydogumevi.gov.tr

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes