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

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.

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Key information

Conditions

Cord Blood Collection Cesarean

Sex eligibility

Female

Study type

Observational

Primary location

Ankara University Faculty of Medicine, Department of Obstetrics and Gynecology

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Umbilical cord blood collection, in-utero

Procedure

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.

Primary outcomes

Postoperative hemoglobin levels

Time frame: 8 hours

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

Time frame: 8 hours

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

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Collaborators

Middle East Technical University

Registry information

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Apr 13, 2015
Registry last updated: Jun 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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