Condition category
Pregnancy and Childbirth
Date applied
12/11/2002
Date assigned
12/11/2002
Last edited
27/08/2009
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 Samir Hidar

ORCID ID

Contact details

71 Rue CH Gallala
H-Sousse
4011
Tunisia
+216 98404526
HIDAR.SAMIR@gnet.tn

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

DEDIAR (from the French "Delivrance Dirigée versus délivrance Artificielle")

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Obstetrics and gynaecology

Intervention

Just before entering the operating room for a Caesarean section, the patients will be randomised in two groups:
1. Direct manual placenta extraction group: the obstetrician's hand is introduced into the uterine cavity and the placenta is removed after creating a cleavage plane
2. Spontaneous placenta removal group: the obstetrician applies gentle traction on the umbilical cord until the placenta passes through the uterine incision

Principal participant variables include: maternal age and parity, gestational age, previous caesarean section, duration of labour, duration of ruptured membranes.

Indications for caesarean section include: elective repeat, labour arrest, malpresentation, foetal distress, antepartum hemoglobin, estimated per operative blood loss, endometritis, wound infection, postpartum haemoglobin, postoperative stay.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2002

Overall trial end date

01/01/2003

Reason abandoned

Eligibility

Participant inclusion criteria

All patients requiring elective or emergency Caesarean section with:
1. Gestational age greater than 34 weeks
2. No multiple gestation
3. No placenta praevia

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

302

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2002

Recruitment end date

01/01/2003

Locations

Countries of recruitment

Tunisia

Trial participating centre

71 Rue CH Gallala
H-Sousse
4011
Tunisia

Sponsor information

Organisation

Farhat Hached University Teaching Hospital (Tunisia)

Sponsor details

Boulevard M Karoui
Sousse
4000
Tunisia

Sponsor type

Hospital/treatment centre

Website

http://www.chu-hached.rns.tn/index.html

Funders

Funder type

Hospital/treatment centre

Funder name

Farhat Hached University Teaching Hospital (Tunisia)

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

2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15541854

Publication citations

  1. Results

    Hidar S, Jennane TM, Bouguizane S, Lassoued L, Bibi M, Khaïri H, The effect of placental removal method at cesarean delivery on perioperative hemorrhage: a randomized clinical trial ISRCTN 49779257., Eur. J. Obstet. Gynecol. Reprod. Biol., 2004, 117, 2, 179-182, doi: 10.1016/j.ejogrb.2004.03.014.

Additional files

Editorial Notes