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

This study has been completed.
Sponsor:
Information provided by:
Lester E. Cox Medical Centers
ClinicalTrials.gov Identifier:
NCT00470899
First received: May 4, 2007
Last updated: May 7, 2007
Last verified: May 2007
  Purpose

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 Intervention Phase
Fetomaternal Transfusion
Procedure: drainage of placenta of fetal blood
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Lester E. Cox Medical Centers:

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

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

Enrollment: 86
Study Start Date: January 2005
Study Completion Date: January 2006
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.

  Eligibility

Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470899

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

No publications provided by Lester E. Cox Medical Centers

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00470899     History of Changes
Other Study ID Numbers: CH20041201
Study First Received: May 4, 2007
Last Updated: May 7, 2007
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014