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

This study has been completed.

First Received: May 4, 2007 Last Updated: May 7, 2007 History of Changes

Sponsored by:	Lester E. Cox Medical Centers
Information provided by:	Lester E. Cox Medical Centers
ClinicalTrials.gov Identifier:	NCT00470899

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 III

MedlinePlus related topics: Blood Transfusion and Donation Cesarean Section

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Placental Drainage of Fetal Blood at Cesarean Section on the Incidence of Feto-Maternal Transfusion: A Randomized Controlled Trial

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

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 National Clinical Trials Identifier (NCT ID):

Leavitt BG, Huff DL, Bell LA, Thurnau GR. Placental drainage of fetal blood at cesarean delivery and feto maternal transfusion: a randomized controlled trial. Obstet Gynecol. 2007 Sep;110(3):608-11.

Study ID Numbers:	CH20041201
Study First Received:	May 4, 2007
Last Updated:	May 7, 2007
ClinicalTrials.gov Identifier:	NCT00470899 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Lester E. Cox Medical Centers:

Feto-maternal transfusion
Kleihauer-Betke

Study placed in the following topic categories:

Fetomaternal Transfusion
Hematologic Diseases
Anemia
Infant, Newborn, Diseases
Anemia, Neonatal

Additional relevant MeSH terms:

Fetomaternal Transfusion
Hematologic Diseases
Anemia
Infant, Newborn, Diseases
Anemia, Neonatal

ClinicalTrials.gov processed this record on May 07, 2009