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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Blood Loss; Delayed Cord Clamping; Hemoglobin
• Intervention / Treatment: Procedure: Delayed cord clamping (30s); Procedure: Delayed cord clamping (60s); Procedure: Delayed cord clamping (90s)

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.

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Delay 30s group; Cord clamping will be delayed at 30 seconds after delivery.	Procedure: Delayed cord clamping (30s); The same as that stated in arm descriptions.
Experimental: Delay 60s group; Cord clamping will be delayed at 60 seconds after delivery.	Procedure: Delayed cord clamping (60s); The same as that stated in arm descriptions.
Experimental: Delay 90s group; Cord clamping will be delayed at 90 seconds after delivery.	Procedure: Delayed cord clamping (90s); The same as that stated in arm descriptions.
No Intervention: Control group; Cord clamping will be immediate (within 15 seconds) after delivery, in accordance with the standard practice in the study sites

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence rate of neonatal anemia	Defined as hemoglobin <145g/L	Within 72 hours after birth
The incidence rate of neonatal jaundice	The incidence rate of neonatal jaundice	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.	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	Before discharging from hospitals, usually within 1 week after birth
Placental weight	In grams	At birth
Maternal hemoglobin after the cesarean	In venous blood	Within 72 hours after the cesarean
Estimated maternal blood loss	By volume-method and area-method	During the cesarean
The incidence rate of maternal blood transfusion	The incidence rate of maternal blood transfusion	At delivery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The children's hemoglobin	In fingertip blood	At 6, 12, 18 months of age
The children's anemia	Defined as hemoglobin <110 g/L	At 6, 12, 18 months of age
The children's length	In Z-score	At 3, 6, 12, 18 months of age
The children's weight	In Z-score	At 3, 6, 12, 18 months of age
The results of Denver Developmental Screening Test	The abnormal rate	At 3, 6, 12, 18 months of age

Collaborators and Investigators

• Sponsor: Peking University
• Collaborators: National Natural Science Foundation of China; Liuyang Maternal and Child Health Care Hospital; Women and Children's Health Care Hospital of Huantai
• Investigators: Principal Investigator: Jianmeng Liu, Peking University; Study Director: Hongtian Li, Peking University

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2022
• Primary Completion (Actual): May 8, 2023
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 2, 2022
• First Submitted That Met QC Criteria: August 4, 2022
• First Posted (Actual): August 8, 2022

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Anemia; Cesarean delivery; Time window for umbilical cord clamping; Maternal and neonatal health outcome
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: NSFC.82173528

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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
• IPD Sharing 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
• IPD Sharing Access Criteria: Researchers should request the data via the following Email: lihongtian@pku.edu.cn or liujm@pku.edu.cn
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No