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| Name | Class |
|---|---|
| National Natural Science Foundation of China | OTHER_GOV |
| Liuyang Maternal and Child Health Care Hospital | UNKNOWN |
| Women and Children's Health Care Hospital of Huantai | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delay 30s group | Experimental | Cord clamping will be delayed at 30 seconds after delivery. |
|
| Delay 60s group | Experimental | Cord clamping will be delayed at 60 seconds after delivery. |
|
| Delay 90s group | Experimental | Cord clamping will be delayed at 90 seconds after delivery. |
|
| Control group | No Intervention | Cord clamping will be immediate (within 15 seconds) after delivery, in accordance with the standard practice in the study sites |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delayed cord clamping (30s) | Procedure | The same as that stated in arm descriptions. |
| |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianmeng Liu | Peking University | Principal Investigator |
| Hongtian Li | Peking University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liuyang Maternal and Child Health Care Hospital | Guankou | Hunan | 410399 | China | ||
| Women and Children's Health Care Hospital of Huantai |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40280473 | Derived | 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. |
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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
After the publication of the main paper (hopefully before the end of 2024), the data will be available to share to other researchers
Researchers should request the data via the following Email: lihongtian@pku.edu.cn or liujm@pku.edu.cn
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 1, 2022 | Aug 1, 2022 |
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| Delayed cord clamping (60s) |
| Procedure |
The same as that stated in arm descriptions. |
|
| Delayed cord clamping (90s) | Procedure | The same as that stated in arm descriptions. |
|
| 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 |
| 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 |
| Zibo |
| Shandong |
| 256499 |
| China |
| SAP_000.pdf |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000087526 | Umbilical Cord Clamping |
| ID | Term |
|---|---|
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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