- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02414659
Effects of In-utero Cord Blood Collection on Post-operative Hemoglobin Levels
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey, 06100
- Ankara University Faculty of Medicine, Department of Obstetrics and Gynecology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative hemoglobin levels
Time Frame: 8 hours
|
Bloods were drawn from patients during their 8th postoperative hour for control blood counts.
|
8 hours
|
Postoperative hematocrit levels
Time Frame: 8 hours
|
Bloods were drawn from patients during their 8th postoperative hour for control blood counts.
|
8 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Erkan Kalafat, Department of Obstetrics and Gynecology, Ankara University Faculty of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 003 (NuSkin International)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cesarean
-
Charite University, Berlin, GermanyCompletedCesarean Section Complications | Cesarean Delivery Affecting Newborn | Cesarean Delivery Affecting FetusGermany
-
Ataturk UniversityUnknownCesarean Section Complications | Cesarean Section; Complications, Wound, Dehiscence | Cesarean Section, Repeated | Cesarean, Uterine Scar Thickness | Cesarean, Residual Myometrial ThicknessTurkey
-
Assiut UniversityNot yet recruitingCesarean Section Complications | Cesarean Section Niche
-
Recep Tayyip Erdogan University Training and Research...CompletedCesarean Section Complications | Cesarean Section; DehiscenceTurkey
-
Ataturk UniversityCompletedCesarean Section, Repeated | Cesarean, Uterine Scar Thickness | Cesarean, Residual Myometrial ThicknessTurkey
-
University of California, San FranciscoEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedPregnancy | Repeat Cesarean Section | Vaginal Births After CesareanUnited States
-
Uludag UniversityUnknownCesarean Section Complications | Cesarean Wound Disruption | Cesarean Wound; DehiscenceTurkey
-
The First Affiliated Hospital with Nanjing Medical...RecruitingVaginal Birth After Cesarean | Trial of Labor After Cesarean | Spontaneous LaborChina
-
Piazza della Vittoria 14 Studio Medico - Ginecologia...CompletedCesarean Section Complications | Cesarean Wound; DehiscenceItaly
-
Kocaeli UniversityCompletedCesarean Section; Dehiscence | Cesarean Wound; DehiscenceTurkey
Clinical Trials on Umbilical cord blood collection, in-utero
-
Institut Universitari DexeusRecruitingUmbilical Cord BloodSpain
-
Mayo ClinicRecruitingHypoplastic Left Heart Syndrome (HLHS)United States
-
Centre Hospitalier Universitaire de NiceUnknown
-
Van Bölge Eğitim ve Araştırma HastanesiCompletedIntrauterine RetardationTurkey
-
Bundang CHA HospitalWithdrawn
-
Centre Hospitalier Universitaire DijonRecruiting
-
Bundang CHA HospitalWithdrawnCerebral PalsyKorea, Republic of
-
MinYoung Kim, M.D.Completed
-
MinYoung Kim, M.D.CHA UniversityCompletedGlobal Developmental DelayKorea, Republic of