Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05505903 |
| Other study ID # |
0032-22-HYMC-IL |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2022 |
| Est. completion date |
February 28, 2023 |
Study information
| Verified date |
March 2023 |
| Source |
Hillel Yaffe Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The investigators will collect the time interval from birth to arrival to WBN or NICU, the
time interval from arrival to nurse admission, the first measured temperature, and the week
of birth.
The investigators will divide the newborn infants to three groups: infants born vaginally,
infants born by regular Cesarean section, and infants born by friendly Cesarean section, and
compare the groups.
Description:
Introduction Friendly Cesarean section mimics normal vaginal delivery as the newborn is put
on mother's chest immediately after delivery and cutting the umbilical cord, and the mother
even breastfeeds the newborn infant, if she wishes to. Friendly Cesarean section is offered
to the mother if there are no contraindications, such as general anesthesia, fetal distress,
or prematurity. Skin to skin contacts lasts for several minutes, as long as the mothers wish
to, and depend on mothers' medical state, and newborns' medical state.
In friendly Cesarean section, the skin to skin contact technique includes putting the newborn
on mother's chest, and covering them both by a blanket. Yet, during Cesarean section the
mother is covered by a thin paper-like sterile sheet, and as the temperature in operating
room is low, her skin cools gradually from the spinal anesthesia until actually delivering
the newborn infant. So, although the newborn infant is put on the mother's chest and covered
by a blanket, there is a possibility for it to develop hypothermia.
Literature about this issue is rare, so the investigators conducted a study to check this
possibility.
Methods In Hillel Yaffe medical center nurses measure infants temperature on admission to
well-baby nursery (WBN) or neonatal intensive care unit (NICU). Admission is not always
performed on arrival, due to other nurse-tasks, such as other newborn infants treatment, or
breastfeeding education.
The most measureable piece of data that characterize friendly Cesarean section is the longer
time interval from the birth until arrival to WBN or NICU.
Inclusion criteria: infants born within the time study interval. Exclusion criteria: infants
born at less than complete 35 gestational weeks, since there is no for offer friendly
Cesarean section for these births.
The investigators will collect the time interval from birth to arrival to WBN or NICU, the
time interval from arrival to nurse admission, the first measured temperature, and the week
of birth.
The investigators will divide the newborn infants to three groups: infants born vaginally,
infants born by regular Cesarean section, and infants born by friendly Cesarean section, and
compare the groups.
