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Cesarean DeliveryNCT04812223

Timing of Umbilical Cord Clamping in Term Cesarean Deliveries

A study testing Delayed umbilical cord clamping, Early umbilical cord clamping and Milking of the umbilical cord in people with Cesarean Delivery and Delayed Separation of Umbilical Cord, run by Acibadem University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to show that delayed umbilical cord clamping or milking of the umbilical cord in pregnant women undergoing elective cesarean delivery might have better effects than early clamping, on neonatal results without causing maternal hemorrhage or negatively affecting the neonatal outcome , and to… Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
What is being tested?
Delayed umbilical cord clamping, Early umbilical cord clamping and Milking of the umbilical cord
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
204 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 Mar 2021to 29 Jul 2021
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 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • > 37 weeks uncomplicated singleton pregnancy
  • Elective cesarean delivery
  • Cesarean section under regional anesthesia

Who cannot join

  • < 37 weeks pregnancy
  • Surgery performed under general anesthesia
  • Emergent cesarean
  • Multiple pregnancy
  • Medically unstable mother or fetus
  • Uncontrolled maternal diabetes
Show all 11Show fewer
  • Major congenital malformation of chromosomal abnormality of the fetus
  • Intrauterine growth retardation
  • Prenatal asphyxia suspicion
  • True knot in the umbilical cord
  • İn case of meconium aspiration syndrome suspicion

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Acibadem Maslak Hospital

    Istanbul, Sariyer, 34457

Other trials in Turkey (Türkiye)

About this study

Official title: Prospective Randomized Comparison of the Results of Early Clamping, Delayed Clamping and Milking of the Umbilical Cord in Term Cesarean Deliveries

The aim of this study is to show that delayed umbilical cord clamping or milking of the umbilical cord in pregnant women undergoing elective cesarean delivery might have better effects than early clamping, on neonatal results without causing maternal hemorrhage or negatively affecting the neonatal outcome , and to compare the superiority of these three methods to each other.

Read the detailed description

Late clamping of the umbilical cord has been shown to have positive effects such as higher neonatal hemoglobin level, higher iron stores in the newborn around three to six months, and better neurological development. In 2017, American College of Obstetricians and Gynecologists (ACOG) recommended a minimum 30-60 seconds delayed clamping of the cord after a minimum of 30-60 seconds, regardless of the delivery method, in both term and preterm newborns. In addition, optimal placental transfusion can be achieved due to strong uterine tonus in vaginal delivery. However, this is not possible due to decreased uterine tonus and time constraint in cesarean delivery. The main concern in delayed clamping and milking of the umbilical cord is the possibility of maternal anemia due to excessive maternal blood loss in the short term, the need for maternal blood transfusion or maternal intensive care support, and the possibility of conditions such as hyperbilirubinemia, symptomatic polycythemia, and long hospital stay that may cause the need for phototherapy in the newborn. Although there are many studies in the literature regarding the neonatal results of the clamping timing of the umbilical cord, there are a limited number of articles regarding the results in patients who underwent term elective cesarean section. The aim of this study is to show that delayed umbilical cord clamping or milking of the umbilical cord in pregnant women undergoing elective cesarean delivery might have better effects than early clamping, on neonatal results without causing maternal hemorrhage or negatively affecting the neonatal outcome , and to compare the superiority of these three methods to each other.

Being tested
Delayed umbilical cord clamping, Early umbilical cord clamping, Milking of the umbilical cord
Keywords
Cesarean delivery, Umbilical cord clamping, Delayed umbilical cord clamping

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Delayed umbilical cord clampingProcedure or surgery

    The umbilical cord will be clamped 60 seconds after the baby is born.

  • Early umbilical cord clampingProcedure or surgery

    The umbilical cord will be clamped 15 seconds after the baby is born.

  • Milking of the umbilical cordProcedure or surgery

    The cord will be milked 5 times with 2 seconds milking, then letting 2 seconds for spontaneous blood flow.

Study groups in NCT04812223
Study groupRoleWhat they receive
Delayed ClampingActive comparatorIn this group, the umbilical cord will be clamped 60 seconds after the baby is born.
Receives: Procedure: Delayed umbilical cord clamping
Early ClampingActive comparatorIn this group, the umbilical cord will be clamped 15 seconds after the baby is born.
Receives: Procedure: Early umbilical cord clamping
Milking ClampingActive comparatorIn this group in which the umbilical cord will be milked, the cord will be milked 5 times with 2 seconds milking, then letting 2 seconds for spontaneous blood flow.
Receives: Procedure: Milking of the umbilical cord

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postpartum maternal hemorrhage

    Preoperative and postoperative hemoglobin values will be recorded.

    Measured: On postoperative day 0 and day 2

Secondary outcomes (9)

  1. Postpartum maternal anemia

    Blood loss during surgery, need for blood transfusion after surgery will be recorded.

    Measured: İn postpartum 48 hours

  2. Neonatal outcomes

    Weight of the baby

    Measured: Postpartum day 0

  3. Postpartum complaints

    Postpartum nausea, vomiting, headache, dyspnea will be recorded

    Measured: İn postpartum 48 hours

  4. Neonatal anemia

    Hematocrit levels of the newborn will be measured

    Measured: On postpartum day 2

  5. Neonatal jaundice

    Bilirubin levels of the newborn will be measured.

    Measured: On postpartum day 2

  6. Neonatal intensive care unit admission

    Neonatal intensive care unit admissions in postpartum 5 days will be recorded.

    Measured: In postpartum 5 days

  7. Maternal outcomes

    Postpartum maternal blood pressure, pulse will be recorded

    Measured: On postpartum day 2

  8. Newborn phototherapy need

    Need of newborn phototherapy in postpartum 2 weeks will be recorded.

    Measured: In postpartum 2 weeks

  9. Newborn positive pressure ventilation

    Need of newborn positive pressure ventilation in postpartum 5 days will be recorded.

    Measured: Postpartum 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2021
  2. Study start25 Mar 2021
  3. Primary completion25 Jul 2021
  4. Study completion29 Jul 2021

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective randomized
Masking
None (open label)
Enrolment
204 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04812223
Sponsor's protocol ID
ATADEK 2021-01/44
Status last verified
Jul 2021
First submitted
17 Mar 2021
Last updated
3 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Study protocol, statistical analysis might be shared when the study is completed upon request.

Publications

  • Committee Opinion No. 684: Delayed Umbilical Cord Clamping After Birth. Obstet Gynecol. 2017 Jan;129(1):1. doi: 10.1097/AOG.0000000000001860.

    PubMed 28002310

  • Mercer JS, Erickson-Owens DA. Rethinking placental transfusion and cord clamping issues. J Perinat Neonatal Nurs. 2012 Jul-Sep;26(3):202-17; quiz 218-9. doi: 10.1097/JPN.0b013e31825d2d9a.

    PubMed 22843002

  • McDonald SJ, Middleton P, Dowswell T, Morris PS. Effect of timing of umbilical cord clamping of term infants on maternal and neonatal outcomes. Cochrane Database Syst Rev. 2013 Jul 11;2013(7):CD004074. doi: 10.1002/14651858.CD004074.pub3.

    PubMed 23843134

  • Songthamwat M, Witsawapaisan P, Tanthawat S, Songthamwat S. Effect of Delayed Cord Clamping at 30 Seconds and 1 Minute on Neonatal Hematocrit in Term Cesarean Delivery: A Randomized Trial. Int J Womens Health. 2020 Jun 23;12:481-486. doi: 10.2147/IJWH.S248709. eCollection 2020.

    PubMed 32607000

  • 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

  • Qian Y, Ying X, Wang P, Lu Z, Hua Y. Early versus delayed umbilical cord clamping on maternal and neonatal outcomes. Arch Gynecol Obstet. 2019 Sep;300(3):531-543. doi: 10.1007/s00404-019-05215-8. Epub 2019 Jun 15.

    PubMed 31203386

Questions about this trial

What is this clinical trial studying?

A study testing Delayed umbilical cord clamping, Early umbilical cord clamping and Milking of the umbilical cord in people with Cesarean Delivery and Delayed Separation of Umbilical Cord, run by Acibadem 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 3 inclusion and 11 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 3 Aug 2021. 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?

Postpartum maternal hemorrhage (time frame: On postoperative day 0 and day 2). 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 NCT04812223, which also lists 6 linked publications.

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 3 Aug 2021.

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