NCT05492214

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

September 22, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2023

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

8 months

First QC Date

August 2, 2022

Last Update Submit

May 30, 2023

Conditions

Delayed Cord ClampingHemoglobinBlood Loss

Keywords

Cesarean deliveryTime window for umbilical cord clampingMaternal and neonatal health outcomeAnemiaRandomized controlled trial

Outcome Measures

Primary Outcomes (2)

  • The neonatal hemoglobin

    In the heel blood

    Within 72 hours after birth

  • The change in maternal hemoglobin

    Difference in maternal hemoglobin levels before and after the cesarean

    Within 72 hours before the cesarean, and within 72 hours after the cesarean

Secondary Outcomes (8)

  • The incidence rate of neonatal anemia

    Within 72 hours after birth

  • The incidence rate of neonatal jaundice

    Before discharging from hospitals, usually within 1 week after birth

  • Apgar score

    At 1 min, 5 min, and 10 min after birth

  • The incidence rate of neonatal intensive care unit admission

    Before discharging from hospitals, usually within 1 week after birth

  • Placental weight

    At birth

  • +3 more secondary outcomes

Other Outcomes (5)

  • The children's hemoglobin

    At 6, 12, 18 months of age

  • The children's anemia

    At 6, 12, 18 months of age

  • The children's length

    At 3, 6, 12, 18 months of age

  • +2 more other outcomes

Study Arms (4)

Delay 30s group

EXPERIMENTAL

Cord clamping will be delayed at 30 seconds after delivery.

Procedure: Delayed cord clamping (30s)

Delay 60s group

EXPERIMENTAL

Cord clamping will be delayed at 60 seconds after delivery.

Procedure: Delayed cord clamping (60s)

Delay 90s group

EXPERIMENTAL

Cord clamping will be delayed at 90 seconds after delivery.

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

Interventions

Delayed cord clamping (30s)PROCEDURE

The same as that stated in arm descriptions.

Delay 30s group
Delayed cord clamping (60s)PROCEDURE

The same as that stated in arm descriptions.

Delay 60s group
Delayed cord clamping (90s)PROCEDURE

The same as that stated in arm descriptions.

Delay 90s group

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Liuyang Maternal and Child Health Care Hospital

Guankou, Hunan, 410399, China

Location

Women and Children's Health Care Hospital of Huantai

Zibo, Shandong, 256499, China

Location

Related Publications (1)

  • 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.

    PMID: 40280473DERIVED

MeSH Terms

Conditions

HemorrhageAnemia

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Jianmeng Liu

    Peking University

    PRINCIPAL INVESTIGATOR

  • Hongtian Li

    Peking University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2022

First Posted

August 8, 2022

Study Start

September 22, 2022

Primary Completion

May 8, 2023

Study Completion

December 1, 2024

Last Updated

May 31, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
After the publication of the main paper (hopefully before the end of 2024), the data will be available to share to other researchers
Access Criteria
Researchers should request the data via the following Email: lihongtian@pku.edu.cn or liujm@pku.edu.cn

Locations

CN(2)