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

Fetomaternal Transfusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00470899
• Other study ID #: CH20041201
• Status: Completed
• Phase: Phase 3
• First received: May 4, 2007
• Last updated: April 6, 2015
• Start date: January 2005
• Est. completion date: January 2006

Study information

• Verified date: May 2007
• Source: Lester E. Cox Medical Centers
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fetomaternal Transfusion

Intervention

Procedure:
• drainage of placenta of fetal blood

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lester E. Cox Medical Centers

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence/absence of fetal blood in maternal circulation		within 12 hours postoperatively
Secondary	no secondary outcome measures		end of study