跳至主要内容
临床试验/NCT02414659
NCT02414659已完成不适用

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

Ankara University1 个研究点 分布在 1 个国家目标入组 399 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
399
试验地点
1
主要终点
Postoperative hemoglobin levels

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Postoperative hemoglobin levels

时间窗: 8 hours

Bloods were drawn from patients during their 8th postoperative hour for control blood counts.

Postoperative hematocrit levels

时间窗: 8 hours

Bloods were drawn from patients during their 8th postoperative hour for control blood counts.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Erkan Kalafat

Research Assistant

Ankara University

研究点 (1)

Loading locations...

相似试验