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

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ClinicalTrials.gov Identifier: NCT00470899
Recruitment Status : Completed
First Posted : May 8, 2007
Last Update Posted : April 7, 2015
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Fetomaternal Transfusion Procedure: drainage of placenta of fetal blood Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effect of Placental Drainage of Fetal Blood at Cesarean Section on the Incidence of Feto-Maternal Transfusion: A Randomized Controlled Trial
Study Start Date : January 2005
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: placental drainage Procedure: drainage of placenta of fetal blood
No Intervention: no drainage of fetal blood



Primary Outcome Measures :
  1. Presence/absence of fetal blood in maternal circulation [ Time Frame: within 12 hours postoperatively ]

Secondary Outcome Measures :
  1. no secondary outcome measures [ Time Frame: end of study ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00470899


Sponsors and Collaborators
Lester E. Cox Medical Centers
Investigators
Study Director: Laird A Bell, MD, MPH Lester E. Cox Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00470899     History of Changes
Other Study ID Numbers: CH20041201
First Posted: May 8, 2007    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: May 2007

Keywords provided by Lester E. Cox Medical Centers:
Feto-maternal transfusion
Kleihauer-Betke

Additional relevant MeSH terms:
Fetomaternal Transfusion
Anemia, Neonatal
Anemia
Hematologic Diseases
Infant, Newborn, Diseases