Cesarean Section
Conditions
Keywords
Cesarean, incision, suture,
Brief summary
This was an unblinded randomized controlled trial. Women were randomized to uterine closure with the knotless barbed suture (Stratafix PDS, Ethicon) or Vicryl (Ethicon) at the time of elective cesarean. The primary outcome was closure time of the uterine incision. Also measured were blood loss during incision closure and the use of additional hemostatic sutures. Informed consent was obtained
Interventions
DEVICEKnotless barbed suture
uterine incision closure
DEVICEpolyglactin 910
uterine incision closure
Sponsors
Ziv Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
unblinded
Intervention model description
Knotless barbed suture vs conventional suture of uterine incision
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* elective cesarean * elective repeat cesarean
Exclusion criteria
* emergent or urgent cesarean * PROM * chorioamninitis * placental abruption * placenta previa or accreta * known uterine fibroids * women with known medical problems such as coagulopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uterine incision closure time | 5 months | uterine incision closure time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| uterine incision blood loss | 5 months | uterine incision blood loss |
| hemostatic suture use | 5 months | hemostatic suture use |
Countries
Israel
Outcome results
None listed