Effects of In-utero Cord Blood Collection on Post-operative Hemoglobin Levels
1 other identifier
observational
399
1 country
1
Brief Summary
Umbilical cord blood (UCB) collection and storage is a rapidly advancing field in hematology due to UCB's use for treatment of many hematological diseases, including but not limited to, Fanconi anemia, thalassemia, leukaemia and metabolic storage diseases. Primarily, there are two ways for UCB harvesting, first in-utero collection and second ex-utero collection. Depending on the amount of UCB collected, in-utero harvesting practice prolongs the operative time of cesarean delivery and speculatively increases intraoperative blood loss. The aim of this study is to determine UCB collection's effect on intraoperative bleeding in women undergoing elective cesarean delivery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2015
Shorter than P25 for all trials
1 active site
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
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 5, 2015
CompletedFirst Posted
Study publicly available on registry
April 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedJune 23, 2015
June 1, 2015
2 months
April 5, 2015
June 22, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Postoperative hemoglobin levels
Bloods were drawn from patients during their 8th postoperative hour for control blood counts.
8 hours
Postoperative hematocrit levels
Bloods were drawn from patients during their 8th postoperative hour for control blood counts.
8 hours
Study Arms (2)
Cesarean delivery, cord blood collected
Cesarean delivery patient who opted for cord blood collection during procedure. Cord blood was collected in-utero after delivery and after clamping of the umbilical cord. After cord blood collection operation was continued.
Cesarean delivery, control
Routine cesarean delivery patients.
Interventions
Umbilical cord blood was collected during cesarean, after delivery of the baby and after clamping of the cord. Blood was collected into a standard blood donation bag with (Capacity: 450 mL) a 16 G venipuncture needle. Needle was left in place after umbilical vein is collapsed and no more blood flow happens spontaneously.
Eligibility Criteria
Elective cesarean deliveries
You may qualify if:
- Elective cesarean deliveries
- Women with a blood count results maximum 30 days prior to delivery
You may not qualify if:
- Emergent cesarean deliveries
- Cesarean deliveries due to placental adhesion abnormalities or placenta previa
- Patients on anticoagulation regimens
- Postpartum bleeding due to uterine atony, retained placenta
- Patients with a history of bleeding 30 days prior to delivery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ankara Universitylead
- Middle East Technical Universitycollaborator
Study Sites (1)
Ankara University Faculty of Medicine, Department of Obstetrics and Gynecology
Ankara, 06100, Turkey (Türkiye)
Study Officials
- PRINCIPAL INVESTIGATOR
Erkan Kalafat
Department of Obstetrics and Gynecology, Ankara University Faculty of Medicine
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant
Study Record Dates
First Submitted
April 5, 2015
First Posted
April 13, 2015
Study Start
March 1, 2015
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
June 23, 2015
Record last verified: 2015-06