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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Delayed Cord Clamping, Hemoglobin, Blood Loss

Intervention / Treatment
-----------------
* Procedure: Delayed cord clamping (30s)
* Procedure: Delayed cord clamping (60s)
* Procedure: Delayed cord clamping (90s)


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Delay 30s group<br>Cord clamping will be delayed at 30 seconds after delivery. | Procedure: Delayed cord clamping (30s)<br>* The same as that stated in arm descriptions.<br>|
| Experimental: Delay 60s group<br>Cord clamping will be delayed at 60 seconds after delivery. | Procedure: Delayed cord clamping (60s)<br>* The same as that stated in arm descriptions.<br>|
| Experimental: Delay 90s group<br>Cord clamping will be delayed at 90 seconds after delivery. | Procedure: Delayed cord clamping (90s)<br>* The same as that stated in arm descriptions.<br>|
| No Intervention: Control group<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cesarean delivery, Time window for umbilical cord clamping, Maternal and neonatal health outcome, Anemia, Randomized controlled trial