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Completed

NCT Number: NCT00470899

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

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.

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Key information

Conditions

Fetomaternal Transfusion Anemia Anemia, Neonatal Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hematologic Diseases Hemic and Lymphatic Diseases Infant, Newborn, Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

drainage of placenta of fetal blood

Procedure

Primary outcomes

  1. Presence/absence of fetal blood in maternal circulation

    Time frame: within 12 hours postoperatively

Secondary outcomes

  1. no secondary outcome measures

    Time frame: end of study

Sponsors and collaborators

Lead sponsor

Lester E. Cox Medical Centers

Other

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2006
First posted
May 8, 2007
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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