Delayed Cord ClampingNCT05492214

The Effect of Time Window for Umbilical Cord Clamping During Cesareans on Offspring Hemoglobin and Maternal Blood Loss

A study testing Delayed cord clamping (30s), Delayed cord clamping (60s) and Delayed cord clamping (90s) in people with Delayed Cord Clamping and Hemoglobin, run by Peking University at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Any age, women onlyHealthy volunteers can take part
Conditions the study is for: Delayed Cord Clamping, Hemoglobin, Blood Loss
What is being tested?: Delayed cord clamping (30s), Delayed cord clamping (60s) and Delayed cord clamping (90s)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 360 participants
Where: 2 sitesChina
Study dates: 22 Sep 2022to Dec 2024
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 Any age
Women only
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

local resident in Liuyang city, Huantai county and their surrounding areas
Singleton pregnancy
Elective caesarean, or cesarean section after the start of labor but the cervix is less than 3 cm
Term pregnancy (≥37 weeks of gestation), and the fetal weight was estimated ≥2500g by intrauterine ultrasound
Written informed consent is obtained

Who cannot join

Pregnant women with the following risk factors: severe hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥110mmHg), preeclampsia, chronic hypertension with preeclampsia, diabetes mellitus with severe microangiopathy, placenta previa, placenta implantation, placental abruption, intrauterine distress, prenatal infection, severe anemia (hemoglobin<7g/dL), coagulation disorders, thrombosis disease
Plan to retain cord blood
Rh-negative pregnant women
Prenatal diagnosis of fetal abnormalities which may lead to difficulties in cesareans or adverse pregnancy outcomes, such as abnormal heart monitoring, fetal distress, malformation, anemia, and intrauterine growth restrictions
Other conditions not suitable for intervention as judged by obstetricians

Trial locations and contacts

2 sites in 1 country.

China2 sites

Liuyang Maternal and Child Health Care Hospital
Guankou, Hunan, 410399
Women and Children's Health Care Hospital of Huantai
Zibo, Shandong, 256499

Other trials in China

About this study

Official title: The Effect of Time Window for Umbilical Cord Clamping During Cesarean Section on the Health Outcomes of Offspring Hemoglobin and Maternal Blood Loss

This is a randomized controlled trial, aiming to evaluate the effects of time window for umbilical cord clamping during cesarean section on the health outcomes of offspring hemoglobin，maternal blood loss，and children's growth and development. It will be conducted in Liuyang city and Huantai county of China, and the targeted sample size is 360 (180 in each site). All the eligible pregnant women will be randomly assigned to one of the four groups (three intervention groups and one control group), and their babies will be followed up to 18 months of age.

Read the detailed description

The World Health Organization and American College of Obstetricians and Gynecologists have recommended a delay in umbilical cord clamping after birth, irrespective of delivery modes, which was based on studies from vaginal deliveries rather than cesareans. In cesareans, the optimal time window for umbilical cord clamping has not been determined, and the relevant safety data are limited. In this randomized study, the investigators aim to evaluate the impacts of time window for umbilical cord clamping during cesarean section on maternal and child health outcomes, and to evaluate the optimal timing of the clamping. The investigators are planning to enroll 360 pregnant women scheduled for cesareans, and to randomly allocate them into four groups: the umbilical cord will be clamped within 15 seconds (immediately), or delayed after deliveries for 30, 60, and 90 seconds, respectively. Babies will be followed up at 3, 6, 12, and 18 months of age. Maternal hemoglobin before and after cesareans, neonatal hemoglobin, children's hemoglobin at 6, 12, 18 months of age will be measured. At each follow-up visit, children's length and weight will be measured, their development will be assessed, and a questionnaire survey including information on feeding, sleep, and medication will be conducted. The primary outcomes are the neonatal hemoglobin and the change in maternal hemoglobin. The secondary outcomes include the incidence rate of neonatal anemia and jaundice, Apgar score, the incidence rate of neonatal intensive care unit (NICU) admission, placental weight, maternal hemoglobin after the cesarean, estimated maternal blood loss, and the incidence rate of maternal blood transfusion. In addition, the children's hemoglobin, anemia, growth and development are considered as the exploratory secondary outcomes.

Conditions: Delayed Cord Clamping, Hemoglobin, Blood Loss
Being tested: Delayed cord clamping (30s), Delayed cord clamping (60s), Delayed cord clamping (90s)
Keywords: Cesarean delivery, Time window for umbilical cord clamping, Maternal and neonatal health outcome, Anemia, Randomized controlled trial
Medical subject headings: Hemorrhage, Anemia

What participants receive

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

Delayed cord clamping (30s)Procedure or surgery
The same as that stated in arm descriptions.
Delayed cord clamping (60s)Procedure or surgery
The same as that stated in arm descriptions.
Delayed cord clamping (90s)Procedure or surgery
The same as that stated in arm descriptions.

Study groups in NCT05492214
Study group	Role	What they receive
Delay 30s group	Experimental	Cord clamping will be delayed at 30 seconds after delivery. Receives: Procedure: Delayed cord clamping (30s)
Delay 60s group	Experimental	Cord clamping will be delayed at 60 seconds after delivery. Receives: Procedure: Delayed cord clamping (60s)
Delay 90s group	Experimental	Cord clamping will be delayed at 90 seconds after delivery. Receives: Procedure: Delayed cord clamping (90s)
Control group	No intervention	Cord clamping will be immediate (within 15 seconds) after delivery, in accordance with the standard practice in the study sites

What is being measured

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

The neonatal hemoglobin
In the heel blood
Measured: Within 72 hours after birth
The change in maternal hemoglobin
Difference in maternal hemoglobin levels before and after the cesarean
Measured: Within 72 hours before the cesarean, and within 72 hours after the cesarean

Secondary outcomes (8)

The incidence rate of neonatal anemia
Defined as hemoglobin <145g/L
Measured: Within 72 hours after birth
The incidence rate of neonatal jaundice
The incidence rate of neonatal jaundice
Measured: Before discharging from hospitals, usually within 1 week after birth
Apgar score
An indicator for the activity, pulse, grimace, appearance, and respiration of neonates. It ranges from 0 to 10, the higher the better.
Measured: At 1 min, 5 min, and 10 min after birth
The incidence rate of neonatal intensive care unit admission
The incidence rate of neonatal intensive care unit admission
Measured: Before discharging from hospitals, usually within 1 week after birth
Placental weight
In grams
Measured: At birth
Maternal hemoglobin after the cesarean
In venous blood
Measured: Within 72 hours after the cesarean
Estimated maternal blood loss
By volume-method and area-method
Measured: During the cesarean
The incidence rate of maternal blood transfusion
The incidence rate of maternal blood transfusion
Measured: At delivery

Timeline

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

22 Sep 2022Dec 2024

First posted8 Aug 2022
Study start22 Sep 2022
Primary completion8 May 2023
Study completionDec 2024 (estimated)

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 Delayed Cord ClampingStudies of the same condition, open and under way.
More trials run by Peking 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: 360 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05492214
Sponsor's protocol ID: NSFC.82173528
Status last verified: May 2023
First submitted: 2 Aug 2022
Last updated: 31 May 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The IPD will be shared upon the request of other researchers, and all the key variables that will be reported in the main paper are planned to be shared

Publications

Song Q, Li H, Mu Y, Xiong Y, Liu Y, Liu Y, Jin C, Huang X, Zhao L, Zhang M, Zhou Y, Liu J. Effects of Delayed Umbilical Cord Clamping at Different Timings on Neonatal Hemoglobin and Maternal Blood Loss During Cesarean Delivery at Term: A Randomized Controlled Trial. J Pediatr. 2025 Aug;283:114620. doi: 10.1016/j.jpeds.2025.114620. Epub 2025 Apr 23.
PubMed 40280473

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Prone Positioning During Delayed Cord Clamping
Delayed Cord Clamping
Active, not recruiting
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
IVH- Intraventricular Hemorrhage, Extreme Prematurity
Not yet recruiting
30-Second Versus Pulsation-Based Delayed Cord Clamping in Term Newborns
Umbilical Cord Clamping
Recruiting
Cord Clamping Among Neonates With Congenital Heart Disease
Congenital Heart Disease (CHD)
Enrolling by invitation
The Effect of Different Positions Given to the Newborn During Delayed Cord Clamping on Physiological Indicators and Comfort
Newborn Infant, Newborn Health

All Delayed Cord Clamping trials

Study at a glance

From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Time Window for Umbilical Cord Clamping During Cesarean Section on the Health Outcomes of Offspring Hemoglobin and Maternal Blood Loss
ClinicalTrials.gov ID: NCT05492214
Acronym / sponsor ID: NSFC.82173528
Conditions: Delayed Cord Clamping, Hemoglobin, Blood Loss
Keywords: Cesarean delivery, Time window for umbilical cord clamping, Maternal and neonatal health outcome, Anemia, Randomized controlled trial
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 360 participants (estimated)
Lead sponsor: Peking UniversityUniversity, hospital or other
Collaborators: National Natural Science Foundation of China, Liuyang Maternal and Child Health Care Hospital, Women and Children's Health Care Hospital of Huantai
Study start: 22 Sep 2022 (actual)
Primary completion: 8 May 2023 (actual)
Study completion: Dec 2024 (estimated)
First posted: 8 Aug 2022 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Delay 30s group	Experimental	Procedure: Delayed cord clamping (30s)Cord clamping will be delayed at 30 seconds after delivery.
Delay 60s group	Experimental	Procedure: Delayed cord clamping (60s)Cord clamping will be delayed at 60 seconds after delivery.
Delay 90s group	Experimental	Procedure: Delayed cord clamping (90s)Cord clamping will be delayed at 90 seconds after delivery.
Control group	No intervention	–Cord clamping will be immediate (within 15 seconds) after delivery, in accordance with the standard practice in the study sites

Who may qualify

Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

local resident in Liuyang city, Huantai county and their surrounding areas
Singleton pregnancy
Elective caesarean, or cesarean section after the start of labor but the cervix is less than 3 cm
Term pregnancy (≥37 weeks of gestation), and the fetal weight was estimated ≥2500g by intrauterine ultrasound
Written informed consent is obtained

Key exclusion criteria (5 listed)

Pregnant women with the following risk factors: severe hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥110mmHg), preeclampsia, chronic hypertension with preeclampsia, diabetes mellitus with severe microangiopathy, placenta previa, placenta implantation, placental abruption, intrauterine distress, prenatal infection, severe anemia (hemoglobin<7g/dL), coagulation disorders, thrombosis disease
Plan to retain cord blood
Rh-negative pregnant women
Prenatal diagnosis of fetal abnormalities which may lead to difficulties in cesareans or adverse pregnancy outcomes, such as abnormal heart monitoring, fetal distress, malformation, anemia, and intrauterine growth restrictions
Other conditions not suitable for intervention as judged by obstetricians

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
Delayed cord clamping (30s)The same as that stated in arm descriptions.	Procedure or surgery	Delay 30s group
Delayed cord clamping (60s)The same as that stated in arm descriptions.	Procedure or surgery	Delay 60s group
Delayed cord clamping (90s)The same as that stated in arm descriptions.	Procedure or surgery	Delay 90s group

Primary outcome

The neonatal hemoglobin
Time frame: Within 72 hours after birth
In the heel blood
The change in maternal hemoglobin
Time frame: Within 72 hours before the cesarean, and within 72 hours after the cesarean
Difference in maternal hemoglobin levels before and after the cesarean

8 secondary outcomes

The incidence rate of neonatal anemia
Time frame: Within 72 hours after birth
The incidence rate of neonatal jaundice
Time frame: Before discharging from hospitals, usually within 1 week after birth
Apgar score
Time frame: At 1 min, 5 min, and 10 min after birth
The incidence rate of neonatal intensive care unit admission
Time frame: Before discharging from hospitals, usually within 1 week after birth
Placental weight
Time frame: At birth
Maternal hemoglobin after the cesarean
Time frame: Within 72 hours after the cesarean
Estimated maternal blood loss
Time frame: During the cesarean
The incidence rate of maternal blood transfusion
Time frame: At delivery

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
Derived from this study: PubMed 40280473Song Q, Li H, Mu Y, Xiong Y, Liu Y, Liu Y, Jin C, Huang X, Zhao L, Zhang M, Zhou Y, Liu J. Effects of Delayed Umbilical Cord Clamping at Different Timings on Neonatal Hemoglobin and Maternal Blood Loss During Cesarean Delivery at Term: A Randomized Controlled Trial. J Pediatr. 2025 Aug;283:114620. doi: 10.1016/j.jpeds.2025.114620. Epub 2025 Apr 23.
Individual participant dataSharing planned: Yes. The IPD will be shared upon the request of other researchers, and all the key variables that will be reported in the main paper are planned to be shared

Related trials for Delayed Cord Clamping

Active, not recruiting
Prone Positioning During Delayed Cord Clamping
Delayed Cord Clamping
Active, not recruiting
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
IVH- Intraventricular Hemorrhage, Extreme Prematurity
Not yet recruiting
30-Second Versus Pulsation-Based Delayed Cord Clamping in Term Newborns
Umbilical Cord Clamping
Recruiting
Cord Clamping Among Neonates With Congenital Heart Disease
Congenital Heart Disease (CHD)
Enrolling by invitation
The Effect of Different Positions Given to the Newborn During Delayed Cord Clamping on Physiological Indicators and Comfort
Newborn Infant, Newborn Health

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.

Jianmeng Liu principal investigator

Peking University

Hongtian Li study director

Peking University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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: status not confirmed, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. 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?

Results are not available in the source record.

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?

The neonatal hemoglobin (time frame: Within 72 hours after birth). 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?

On the ClinicalTrials.gov record for NCT05492214, 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 31 May 2023.