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

Sponsor
Ankara University (Other)
Overall Status
Completed
CT.gov ID
NCT02414659
Collaborator
Middle East Technical University (Other)
399
1
2
199.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Umbilical cord blood collection, in-utero

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 Design

Study Type:
Observational
Actual Enrollment :
399 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Effects of In-utero Cord Blood Collection on Post-operative Hemoglobin Levels
Study Start Date :
Mar 1, 2015
Actual Primary Completion Date :
May 1, 2015
Actual Study Completion Date :
May 1, 2015

Arms and Interventions

Arm Intervention/Treatment
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.

Procedure: Umbilical cord blood collection, in-utero
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.

Cesarean delivery, control

Routine cesarean delivery patients.

Outcome Measures

Primary Outcome Measures

  1. Postoperative hemoglobin levels [8 hours]

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

  2. Postoperative hematocrit levels [8 hours]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ankara University Faculty of Medicine, Department of Obstetrics and Gynecology Ankara Turkey 06100

Sponsors and Collaborators

  • Ankara University
  • Middle East Technical University

Investigators

  • Principal Investigator: Erkan Kalafat, Department of Obstetrics and Gynecology, Ankara University Faculty of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Erkan Kalafat, Research Assistant, Ankara University
ClinicalTrials.gov Identifier:
NCT02414659
Other Study ID Numbers:
  • 003
First Posted:
Apr 13, 2015
Last Update Posted:
Jun 23, 2015
Last Verified:
Jun 1, 2015

Study Results

No Results Posted as of Jun 23, 2015