Blood Loss, Delayed Cord Clamping, Hemoglobin
Conditions
Keywords
Cesarean delivery, Time window for umbilical cord clamping, Maternal and neonatal health outcome, Anemia, Randomized controlled trial
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.
Interventions
PROCEDUREDelayed cord clamping (30s)
The same as that stated in arm descriptions.
PROCEDUREDelayed cord clamping (60s)
The same as that stated in arm descriptions.
PROCEDUREDelayed cord clamping (90s)
The same as that stated in arm descriptions.
Sponsors
National Natural Science Foundation of China
Liuyang Maternal and Child Health Care Hospital
Women and Children's Health Care Hospital of Huantai
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The neonatal hemoglobin | Within 72 hours after birth | In the heel blood |
| The change in maternal hemoglobin | Within 72 hours before the cesarean, and within 72 hours after the cesarean | Difference in maternal hemoglobin levels before and after the cesarean |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apgar score | 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. |
| The incidence rate of neonatal intensive care unit admission | Before discharging from hospitals, usually within 1 week after birth | The incidence rate of neonatal intensive care unit admission |
| Placental weight | At birth | In grams |
| Maternal hemoglobin after the cesarean | Within 72 hours after the cesarean | In venous blood |
| Estimated maternal blood loss | During the cesarean | By volume-method and area-method |
| The incidence rate of maternal blood transfusion | At delivery | The incidence rate of maternal blood transfusion |
| The incidence rate of neonatal anemia | Within 72 hours after birth | Defined as hemoglobin \<145g/L |
| The incidence rate of neonatal jaundice | Before discharging from hospitals, usually within 1 week after birth | The incidence rate of neonatal jaundice |
Other
| Measure | Time frame | Description |
|---|---|---|
| The children's weight | At 3, 6, 12, 18 months of age | In Z-score |
| The results of Denver Developmental Screening Test | At 3, 6, 12, 18 months of age | The abnormal rate |
| The children's anemia | At 6, 12, 18 months of age | Defined as hemoglobin \<110 g/L |
| The children's length | At 3, 6, 12, 18 months of age | In Z-score |
| The children's hemoglobin | At 6, 12, 18 months of age | In fingertip blood |
Countries
China
Outcome results
None listed