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
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04588350 -
Clinical Investigation Evaluating a New Autotransfusion Device in Cardiac Surgery
|
N/A | |
| Completed |
NCT05426564 -
Exploratory Assessment of the Quantra® System in Adult ECMO Patients
|
||
| Withdrawn |
NCT05518279 -
Early Administration Of Tranexamic Acid And Acute Blood Loss In Patients With Hip Fractures
|
Phase 3 | |
| Enrolling by invitation |
NCT02910115 -
Cooling the Uterus in C-section After Dysfunctional Labor
|
N/A | |
| Completed |
NCT02569658 -
Investigation of Intravenous Tranexamic Acid With Anatomic and Reverse Total Shoulder Arthroplasty
|
N/A | |
| Completed |
NCT01048658 -
Sevoflurane as an Anesthetic During Dilation and Evacuation Procedures
|
Phase 4 | |
| Terminated |
NCT02908516 -
Safety and Efficacy of Oral TXA in Reducing Blood Loss and Transfusion in Hip Fractures
|
Phase 4 | |
| Completed |
NCT04089865 -
Oral Versus Intravenous Tranexamic Acid
|
Phase 4 | |
| Recruiting |
NCT06403163 -
Transfusion Surveillance in Anaesthesia
|
||
| Recruiting |
NCT02265562 -
Rectal Misoprostol and Blood Loss During Abdominal Hysterectomy
|
Phase 3 | |
| Completed |
NCT02312440 -
Comparison of Topical and Intravenous Tranexamic Acid in Total Hip Arthroplasty
|
Phase 3 | |
| Completed |
NCT02083809 -
Effects of Oxytocin on Bleeding Outcomes During Dilation and Evacuation
|
N/A | |
| Completed |
NCT01895101 -
The Effect on Blood Loss of Topical and Intravenous Tranexamic Acid in Cardiac Surgery Patients
|
Phase 4 | |
| Completed |
NCT00990288 -
The Use of FLOSEAL to Reduce Bleeding in Total Knee Replacement Surgery
|
Phase 4 | |
| Completed |
NCT01099475 -
Effect of Intermittent Pedicle Clamping on Hepatocellular Injury During Liver Surgery
|
N/A | |
| Completed |
NCT03365999 -
Oral Tranexamic Acid vs. Oral Aminocaproic Acid to Reduce Blood Loss and Transfusion After Total Knee Replacement.
|
Phase 2 | |
| Recruiting |
NCT05550623 -
Pneumatic Tourniquet Versus no Tourniquet in Transfemoral Amputation
|
N/A | |
| Completed |
NCT05012202 -
Validating a New Point-of-care Device for Estimation of Blood Count in Pregnant Women
|
||
| Completed |
NCT02311309 -
Epidemiology of Severe Peroperative Bleeding During Scheduled Surgery
|
N/A | |
| Withdrawn |
NCT01712971 -
Reduced Intra-operative Blood Loss in Pancreaticoduodenectomy for Pancreatic or Peri-ampullary Tumors; Monocentric Trial on Standard Open Versus Minimally Invasive Surgery
|
N/A |