Effects of In-utero Cord Blood Collection on Post-operative Hemoglobin Levels

Completed

• Conditions: Cord Blood Collection; Cesarean
• Interventions: Procedure: Umbilical cord blood collection, in-utero

• Registration Number: NCT02414659
• Lead Sponsor: Ankara University

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.

Detailed Description

Elective cesarean deliveries that occurred in Ankara University Department of Obstetrics and Gynecology between March 2014 and February 2015 were enrolled in the study. Deliveries were divided into two groups depending whether cord blood was collected or not. All cesarean deliveries were performed via Joel-Cohen incisions. Cord blood was harvested in-utero, i.e. while leaving the placenta inside the uterus, after delivery of the baby and clamping of the cord. After UCB collection, placenta was delivered and hysterotomy site was repaired in one layer with continuous locking. Postpartum hemorrhage prophylaxis were performed with one dose of 0.2 mg methylergonovine maleate. Postoperatively patients were hydrated with 100cc per hour infusion of isotonic liquids and bloods were drawn at eight hours postoperatively for control blood counts. Amount of blood loss was estimated by subtracting preoperative hemoglobin and hematocrit levels from postoperative hemoglobin and hematocrit. Delta hemoglobin and hematocrit levels were compared between two groups. Correlation between amount of UCB collected and blood loss was also analysed.

Patients without a preoperative blood count within 30 days prior to delivery were excluded from the study, along with patients with history of bleeding 30 days prior to delivery. Emergent cesarean deliveries, postpartum bleeding due to uterine atony, retained placenta, cesarean deliveries performed due to placental adhesion abnormalities (placenta previa, placenta accreta), patients on anticoagulation regimens (aspirin, low molecular weight heparin, heparin), patients with a post-operative haemoglobin level higher than pre-operative levels were all excluded from the study. Patients were selected at random from birth register by two people who are blind to pre and post-operative blood count results.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-04-05
• Study First Submitted QC: 2015-04-08
• Study First Posted: 2015-04-13
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-22
• Last Update Posted: 2015-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 399

Inclusion Criteria

• Elective cesarean deliveries
• Women with a blood count results maximum 30 days prior to delivery

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cesarean delivery, cord blood collected	Umbilical cord blood collection, in-utero	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.

Primary Outcome Measures

Name	Time	Method
Postoperative hematocrit levels	8 hours	Bloods were drawn from patients during their 8th postoperative hour for control blood counts.
Postoperative hemoglobin levels	8 hours	Bloods were drawn from patients during their 8th postoperative hour for control blood counts.

Trial Locations

Locations (1)

Ankara University Faculty of Medicine, Department of Obstetrics and Gynecology; 🇹🇷 Ankara, Turkey