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

L

Lester E. Cox Medical Centers

Status and phase

Completed
Phase 3

Conditions

Fetomaternal Transfusion

Treatments

Procedure: drainage of placenta of fetal blood

Study type

Interventional

Funder types

Other

Identifiers

NCT00470899
CH20041201

Details and patient eligibility

About

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.

Full 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.

Enrollment

86 patients

Sex

Female

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

86 participants in 2 patient groups

placental drainage
Experimental group
Treatment:
Procedure: drainage of placenta of fetal blood
no drainage of fetal blood
No Intervention group

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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