NCT00470899

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2005

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2007

Completed
Last Updated

April 7, 2015

Status Verified

May 1, 2007

First QC Date

May 4, 2007

Last Update Submit

April 6, 2015

Conditions

Fetomaternal Transfusion

Keywords

Feto-maternal transfusionKleihauer-Betke

Outcome Measures

Primary Outcomes (1)

  • Presence/absence of fetal blood in maternal circulation

    within 12 hours postoperatively

Secondary Outcomes (1)

  • no secondary outcome measures

    end of study

Study Arms (2)

placental drainage

EXPERIMENTAL
Procedure: drainage of placenta of fetal blood

no drainage of fetal blood

NO INTERVENTION

Interventions

drainage of placenta of fetal bloodPROCEDURE
placental drainage

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All women undergoing cesarean section

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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. doi: 10.1097/01.AOG.0000277262.80793.0d.

    PMID: 17766607DERIVED

MeSH Terms

Conditions

Fetomaternal Transfusion

Condition Hierarchy (Ancestors)

Anemia, NeonatalAnemiaHematologic DiseasesHemic and Lymphatic DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Laird A Bell, MD, MPH

    Lester E. Cox Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 4, 2007

First Posted

May 8, 2007

Study Start

January 1, 2005

Study Completion

January 1, 2006

Last Updated

April 7, 2015

Record last verified: 2007-05