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

Blood Loss Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05492214
• Other study ID #: NSFC.82173528
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 22, 2022
• Est. completion date: December 2024

Study information

• Verified date: May 2023
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 360
• Est. completion date: December 2024
• Est. primary completion date: May 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss
• Delayed Cord Clamping
• Hemoglobin
• Hemorrhage

Intervention

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

Locations

Country	Name	City	State
China	Liuyang Maternal and Child Health Care Hospital	Liuyang	Hunan
China	Women and Children's Health Care Hospital of Huantai	Zibo	Shandong

Sponsors (4)

Lead Sponsor	Collaborator
Peking University	Liuyang Maternal and Child Health Care Hospital, National Natural Science Foundation of China, Women and Children's Health Care Hospital of Huantai

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The children's hemoglobin	In fingertip blood	At 6, 12, 18 months of age
Other	The children's anemia	Defined as hemoglobin <110 g/L	At 6, 12, 18 months of age
Other	The children's length	In Z-score	At 3, 6, 12, 18 months of age
Other	The children's weight	In Z-score	At 3, 6, 12, 18 months of age
Other	The results of Denver Developmental Screening Test	The abnormal rate	At 3, 6, 12, 18 months of age
Primary	The neonatal hemoglobin	In the heel blood	Within 72 hours after birth
Primary	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	The incidence rate of neonatal anemia	Defined as hemoglobin <145g/L	Within 72 hours after birth
Secondary	The incidence rate of neonatal jaundice	The incidence rate of neonatal jaundice	Before discharging from hospitals, usually within 1 week after birth
Secondary	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
Secondary	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
Secondary	Placental weight	In grams	At birth
Secondary	Maternal hemoglobin after the cesarean	In venous blood	Within 72 hours after the cesarean
Secondary	Estimated maternal blood loss	By volume-method and area-method	During the cesarean
Secondary	The incidence rate of maternal blood transfusion	The incidence rate of maternal blood transfusion	At delivery