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Effect of Placental Drainage of Fetal Blood at Cesarean Section on the Incidence of Feto-Maternal Transfusion

Effect of Placental Drainage of Fetal Blood at Cesarean Section on the Incidence of Feto-Maternal Transfusion: A Randomized Controlled Trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00470899
Enrollment
86
Registered
2007-05-08
Start date
2005-01-31
Completion date
2006-01-31
Last updated
2015-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetomaternal Transfusion

Keywords

Feto-maternal transfusion, Kleihauer-Betke

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.

Interventions

PROCEDUREdrainage of placenta of fetal blood

Sponsors

Lester E. Cox Medical Centers
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Presence/absence of fetal blood in maternal circulationwithin 12 hours postoperatively

Secondary

MeasureTime frame
no secondary outcome measuresend of study

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 6, 2026