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

May 30, 2023 updated by: Peking University

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The neonatal hemoglobin
Time Frame: Within 72 hours after birth
In the heel blood
Within 72 hours after birth
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
Within 72 hours before the cesarean, and within 72 hours after the cesarean

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The incidence rate of neonatal anemia
Time Frame: Within 72 hours after birth
Defined as hemoglobin <145g/L
Within 72 hours after birth
The incidence rate of neonatal jaundice
Time Frame: Before discharging from hospitals, usually within 1 week after birth
The incidence rate of neonatal jaundice
Before discharging from hospitals, usually within 1 week after birth
Apgar score
Time Frame: At 1 min, 5 min, and 10 min after birth
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
Time Frame: Before discharging from hospitals, usually within 1 week after birth
The incidence rate of neonatal intensive care unit admission
Before discharging from hospitals, usually within 1 week after birth
Placental weight
Time Frame: At birth
In grams
At birth
Maternal hemoglobin after the cesarean
Time Frame: Within 72 hours after the cesarean
In venous blood
Within 72 hours after the cesarean
Estimated maternal blood loss
Time Frame: During the cesarean
By volume-method and area-method
During the cesarean
The incidence rate of maternal blood transfusion
Time Frame: At delivery
The incidence rate of maternal blood transfusion
At delivery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The children's hemoglobin
Time Frame: At 6, 12, 18 months of age
In fingertip blood
At 6, 12, 18 months of age
The children's anemia
Time Frame: At 6, 12, 18 months of age
Defined as hemoglobin <110 g/L
At 6, 12, 18 months of age
The children's length
Time Frame: At 3, 6, 12, 18 months of age
In Z-score
At 3, 6, 12, 18 months of age
The children's weight
Time Frame: At 3, 6, 12, 18 months of age
In Z-score
At 3, 6, 12, 18 months of age
The results of Denver Developmental Screening Test
Time Frame: At 3, 6, 12, 18 months of age
The abnormal rate
At 3, 6, 12, 18 months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Natural Science Foundation of China
Liuyang Maternal and Child Health Care Hospital
Women and Children's Health Care Hospital of Huantai

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jianmeng Liu, Peking University
  • Study Director: Hongtian Li, Peking University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 22, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 8, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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