Cord Blood CollectionNCT02414659
Effects of In-utero Cord Blood Collection on Post-operative Hemoglobin Levels
An observational study of Cord Blood Collection and Cesarean, run by Ankara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cord Blood Collection, Cesarean
- What is being tested?
- Umbilical cord blood collection, in-utero
- Type of treatment
- Surgery or procedure
- How many people
- 399 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2015to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Elective cesarean deliveries
Who may be able to join
- Elective cesarean deliveries
- Women with a blood count results maximum 30 days prior to delivery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Faculty of Medicine, Department of Obstetrics and Gynecology
Ankara, 06100
About this study
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.
Read the 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.
- Conditions
- Cord Blood Collection, Cesarean
- Being tested
- Umbilical cord blood collection, in-utero
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical cord blood collection, in-uteroProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Umbilical cord blood collection, in-utero | |
| Cesarean delivery, control | Routine cesarean delivery patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative hemoglobin levels
Bloods were drawn from patients during their 8th postoperative hour for control blood counts.
Measured: 8 hours
Postoperative hematocrit levels
Bloods were drawn from patients during their 8th postoperative hour for control blood counts.
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cord Blood CollectionStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Collaborators
- Middle East Technical University
- Responsible party
- Principal investigator, Erkan Kalafat, Ankara University
- Investigators
- Erkan Kalafat, Principal investigator, Department of Obstetrics and Gynecology, Ankara University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414659
- Sponsor's protocol ID
- 003
- Status last verified
- Jun 2015
- First submitted
- 5 Apr 2015
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of In-utero Cord Blood Collection on Post-operative Hemoglobin Levels
- ClinicalTrials.gov ID
- NCT02414659
- Acronym / sponsor ID
- 003
- Conditions
- Cord Blood Collection, Cesarean
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 399 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Collaborators
- Middle East Technical University
- Study start
- Mar 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 13 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cesarean delivery, cord blood collected | – | Procedure: Umbilical cord blood collection, in-uteroCesarean 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. |
| Cesarean delivery, control | – | –Routine cesarean delivery patients. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Elective cesarean deliveries
Key inclusion criteria (2 listed)
- Elective cesarean deliveries
- Women with a blood count results maximum 30 days prior to delivery
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Umbilical cord blood collection, in-uteroUmbilical 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. | Procedure or surgery | Cesarean delivery, cord blood collected |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erkan Kalafat principal investigator
Department of Obstetrics and Gynecology, Ankara University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cord Blood Collection and Cesarean, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative hemoglobin levels (time frame: 8 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2015.