Maternal Blood LossNCT03150641
Delayed Cord Clamping at Term Cesarean
A study testing Umbilical cord clamping in people with Maternal Blood Loss and Cesarean Delivery, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this research study is to find out how delaying cutting the umbilical cord until one minute after delivery of the baby during a cesarean impacts the amount of blood the mother loses during surgery. The study will also examine the benefits to the newborn from delayed cord clamping during cesarean. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Maternal Blood Loss, Cesarean Delivery, Delayed Cord Clamping
- What is being tested?
- Umbilical cord clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2017to 31 Mar 2018
- Phase
- Interventional
- 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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton gestation
- Scheduled cesarean delivery at term (>=37 weeks)
Who cannot join
- Placenta previa
- Placenta abruption
- Intrauterine growth restriction with abnormal Dopplers
- Fetal anomalies
- Known fetal anemia
- Planned cord blood banking
- Preeclampsia
- Significant maternal anemia (Hgb <=7)
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Maternal Blood Loss With Delayed Cord Clamping During Cesarean Delivery at Term
The purpose of this research study is to find out how delaying cutting the umbilical cord until one minute after delivery of the baby during a cesarean impacts the amount of blood the mother loses during surgery. The study will also examine the benefits to the newborn from delayed cord clamping during cesarean.
Read the detailed description
After delivery of a baby, the umbilical cord is cut to separate the baby from the placenta and the mother. The best time to cut the umbilical cord of full term babies is unknown. Traditionally, the umbilical cord is cut immediately at birth. There is however, continued blood flow from the placenta to the baby after delivery and so there may be a benefit to the baby from waiting to cut the cord until one minute after delivery. Studies show that delaying cutting the cord until at least one minute after delivery increases a full term baby's blood count in first two days of life and increases the baby's iron levels. The impact of delaying cutting the umbilical cord on a mother's health is not fully known. Delaying cutting the cord has minimal impact on the mother's health when the baby is delivered vaginally, but it is not known how delaying cutting the cord impacts the mother's health (and specifically the amount of blood a mother loses at delivery) when the baby is delivered by cesarean.
- Being tested
- Umbilical cord clamping
- Keywords
- Maternal blood loss, Cesarean delivery, Delayed cord clamping, Neonatal health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical cord clampingProcedure or surgery
The umbilical cord will be clamped and cut after delivery, with timing as specified in each arm
| Study group | Role | What they receive |
|---|---|---|
| Immediate cord clamping | Other | Umbilical cord clamped within 15 seconds of delivery of baby Receives: Procedure: Umbilical cord clamping |
| Delayed cord clamping | Experimental | Umbilical cord clamped 60 seconds after delivery of baby Receives: Procedure: Umbilical cord clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal change in hemoglobin on post-operative day #1
Difference in hemoglobin between routine pre-op CBC and a postpartum CBC collected on postoperative day #1, by venipuncture
Measured: Baseline to postoperative day #1 (range 1-4 days)
Secondary outcomes (8)
Postpartum hemorrhage
Incidence of postpartum hemorrhage, defined as EBL >1000cc
Measured: From day of surgery to postpartum discharge (average 3-4 days)
Estimated blood loss
Estimated blood loss at cesarean delivery, based on estimation provider team
Measured: Day of surgery
Need for Need for additional uterotonics
Administration of uterotonics (beyond standard pitocin) during cesarean
Measured: Day of surgery
Maternal blood transfusion
Transfusion of blood products during or after delivery
Measured: From day of surgery to postpartum discharge (average 3-4 days)
Venous cord blood Hgb/Hct
Obtained from cord blood sample
Measured: Day of delivery
Neonatal Hgb/Hct
Obtained from neonatal heel stick
Measured: Day 0-2 of life
APGAR scores
Assigned at delivery
Measured: Day of delivery
Need for phototherapy for jaundice
Any use of phototherapy
Measured: From birth to hospital discharge (average 3-4 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start18 Sep 2017
- Primary completion30 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maternal Blood LossStudies of the same condition, open and under way.
- More trials run by Columbia 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cynthia Gyamfi-Bannerman, MD, Study chair, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03150641
- Sponsor's protocol ID
- AAAR2937
- Status last verified
- May 2019
- First submitted
- 9 May 2017
- Last updated
- 22 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Purisch SE, Ananth CV, Arditi B, Mauney L, Ajemian B, Heiderich A, Leone T, Gyamfi-Bannerman C. Effect of Delayed vs Immediate Umbilical Cord Clamping on Maternal Blood Loss in Term Cesarean Delivery: A Randomized Clinical Trial. JAMA. 2019 Nov 19;322(19):1869-1876. doi: 10.1001/jama.2019.15995.
PubMed 31742629
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Blood Loss With Delayed Cord Clamping During Cesarean Delivery at Term
- ClinicalTrials.gov ID
- NCT03150641
- Acronym / sponsor ID
- AAAR2937
- Keywords
- Maternal blood loss, Cesarean delivery, Delayed cord clamping, Neonatal health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 12 May 2017 (actual)
- 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.
The purpose of this research study is to find out how delaying cutting the umbilical cord until one minute after delivery of the baby during a cesarean impacts the amount of blood the mother loses during surgery. The study will also examine the benefits to the newborn from delayed cord clamping during cesarean.
Detailed description
After delivery of a baby, the umbilical cord is cut to separate the baby from the placenta and the mother. The best time to cut the umbilical cord of full term babies is unknown. Traditionally, the umbilical cord is cut immediately at birth. There is however, continued blood flow from the placenta to the baby after delivery and so there may be a benefit to the baby from waiting to cut the cord until one minute after delivery. Studies show that delaying cutting the cord until at least one minute after delivery increases a full term baby's blood count in first two days of life and increases the baby's iron levels. The impact of delaying cutting the umbilical cord on a mother's health is not fully known. Delaying cutting the cord has minimal impact on the mother's health when the baby is delivered vaginally, but it is not known how delaying cutting the cord impacts the mother's health (and specifically the amount of blood a mother loses at delivery) when the baby is delivered by cesarean.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate cord clamping | Other | Procedure: Umbilical cord clampingUmbilical cord clamped within 15 seconds of delivery of baby |
| Delayed cord clamping | Experimental | Procedure: Umbilical cord clampingUmbilical cord clamped 60 seconds after delivery of baby |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Singleton gestation
- Scheduled cesarean delivery at term (>=37 weeks)
Key exclusion criteria (8 listed)
- Placenta previa
- Placenta abruption
- Intrauterine growth restriction with abnormal Dopplers
- Fetal anomalies
- Known fetal anemia
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 clampingThe umbilical cord will be clamped and cut after delivery, with timing as specified in each arm | Procedure or surgery | Delayed cord clamping, Immediate cord clamping |
Primary outcome
Maternal change in hemoglobin on post-operative day #1
Time frame: Baseline to postoperative day #1 (range 1-4 days)
Difference in hemoglobin between routine pre-op CBC and a postpartum CBC collected on postoperative day #1, by venipuncture
8 secondary outcomes
Postpartum hemorrhage
Time frame: From day of surgery to postpartum discharge (average 3-4 days)
Estimated blood loss
Time frame: Day of surgery
Need for Need for additional uterotonics
Time frame: Day of surgery
Maternal blood transfusion
Time frame: From day of surgery to postpartum discharge (average 3-4 days)
Venous cord blood Hgb/Hct
Time frame: Day of delivery
Neonatal Hgb/Hct
Time frame: Day 0-2 of life
APGAR scores
Time frame: Day of delivery
Need for phototherapy for jaundice
Time frame: From birth to hospital discharge (average 3-4 days)
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 22 May 2019.
- Derived from this study: PubMed 31742629Purisch SE, Ananth CV, Arditi B, Mauney L, Ajemian B, Heiderich A, Leone T, Gyamfi-Bannerman C. Effect of Delayed vs Immediate Umbilical Cord Clamping on Maternal Blood Loss in Term Cesarean Delivery: A Randomized Clinical Trial. JAMA. 2019 Nov 19;322(19):1869-1876. doi: 10.1001/jama.2019.15995.
- Individual participant dataSharing planned: No
Related trials for Maternal Blood Loss
Recruiting
Maternal Outcomes Following Manual Lysis of the Placenta.
Third Stage of Delivery
Active, not recruitingObservational study
Intact Cord Placental Delivery vs Delayed Cord Clamping
Intact Cord Placental Delivery, Delayed Cord Clamping
RecruitingEarly Phase 1
Topical Tranexamic Acid to Reduce Blood Loss During Cesarean Delivery
Cesarean Delivery, Postpartum Hemorrhage (PPH)
Active, not recruiting
Pivotal, Prospective, Multi-centre, Single-arm Study to Evaluate the Safety and Effectiveness of Oli for Identification of Patients, During the Intrapartum Period, Who Are at Higher Risk of Developing Abnormal Postpartum Uterine Bleeding, Including Postpartum Haemorrhage
Post Partum Haemorrhage, Maternal Care Patterns
Not yet recruiting
Improved Child Nutrition and Development Through Social Transfers
Breastfeeding, Breastfeeding Education
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.
Cynthia Gyamfi-Bannerman, MD study chair
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Umbilical cord clamping in people with Maternal Blood Loss and Cesarean Delivery, run by Columbia University at 1 site in United States.
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 8 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 22 May 2019. 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 United States. 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?
Maternal change in hemoglobin on post-operative day #1 (time frame: Baseline to postoperative day #1 (range 1-4 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03150641, which also lists 1 linked publication.
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 22 May 2019.