A prospective randomised trial on the effect of placental removal method on operative blood loss and on incidence of post-Caesarean section infections
| ISRCTN | ISRCTN49779257 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49779257 |
| Protocol serial number | N/A |
| Sponsor | Farhat Hached University Teaching Hospital (Tunisia) |
| Funder | Farhat Hached University Teaching Hospital (Tunisia) |
- Submission date
- 12/11/2002
- Registration date
- 12/11/2002
- Last edited
- 27/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Samir Hidar
Scientific
Scientific
71 Rue CH Gallala
H-Sousse
4011
Tunisia
| Phone | +216 98404526 |
|---|---|
| HIDAR.SAMIR@gnet.tn |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | DEDIAR (from the French "Delivrance Dirigée versus délivrance Artificielle") |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 302 |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 01/01/2003 |
Locations
Countries of recruitment
- Tunisia
Study participating centre
71 Rue CH Gallala
H-Sousse
4011
Tunisia
4011
Tunisia
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? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2004 | Yes | No |
