Effect of Placental Drainage of Fetal Blood at Cesarean Section on the Incidence of Feto-Maternal Transfusion
Phase 3
Completed
- Conditions
- Fetomaternal Transfusion
- Interventions
- Procedure: drainage of placenta of fetal blood
- Registration Number
- NCT00470899
- Lead Sponsor
- Lester E. Cox Medical Centers
- Brief Summary
Study hypothesis: umbilical cord drainage of fetal blood after delivery of the infant would reduce the incidence of feto-maternal transfusion. Patients were randomized to placental drainage or no drainage at the time of cesarean section. The incidence of fetal to maternal transfusion was noted postoperatively.
- Detailed Description
86 patients were randomized to placental drainage vs. no drainage of fetal blood at the time of cesarean section. Kleihauer-Betke testing was performed within 12 hours postoperatively to assess the incidence of feto-maternal transfusion. A significant difference was found between the two groups.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 86
Inclusion Criteria
- All women undergoing cesarean section
Exclusion Criteria
- Preoperative Kleihauer-Betke, known antepartum erythrocyte sensitization, overt vaginal bleeding, history of a previous delivery by low vertical cesarean section, prolonged rupture of membranes, twin gestation, failure to obtain both preoperative and postoperative Kleihauer-Betke tests.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placental drainage drainage of placenta of fetal blood -
- Primary Outcome Measures
Name Time Method Presence/absence of fetal blood in maternal circulation within 12 hours postoperatively
- Secondary Outcome Measures
Name Time Method no secondary outcome measures end of study