Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04323241 |
| Other study ID # |
HNEAH KAEK 2019/KK/10 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2019 |
| Est. completion date |
January 20, 2021 |
Study information
| Verified date |
February 2021 |
| Source |
Haydarpasa Numune Training and Research Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Cesarean delivery is one of the most common major abdominal operation in women worldwide. The
incidence of postpartum infection has been estimated to be 1-4% after vaginal delivery and
10-20% after Cesarean delivery. Although it is widely performed, manual removal of the
placenta is still a conflicting issue due to the risk of post-partum endometritis. All
cesarean patients are randomized according to the removal of placenta from the uterus after
childbirth; manually (Group 1) or controlled cord traction without putting fingers inside the
uterus (Group 2). The aim of this study is to examine whether there is an association between
the method of removal of the placenta and postpartum white blood cell increase in nonanemic,
singleton, low-risk group of women with term pregnancies, who underwent elective cesarean
delivery under general anesthesia.
Description:
Objective:
Cesarean section is one of the most common major abdominal operation in women worldwide and
its rate is increasing every year. Although cesarean birth is considered as safe, it is a
potentially morbid procedure with associated risks of hemorrhage, thromboembolic events,
infection, and anesthesia risks. The incidence of postpartum infection has been estimated to
be 1-4% after vaginal delivery and 10-20% after cesarean section. Manual removal of the
placenta is widely accepted by surgeons worldwide. This method enables the surgeon quick
intervention. Beside, it helps uterine cavity to be examined for damage and the presence of
placental remnants. However, manual removal of the placenta is still a conflicting issue due
to the risk of post-partum endometritis, post-partum hemorrhage and abnormal placentation in
subsequent pregnancies. It is assumed that controlled cord traction reduces the risk of
postpartum hemorrhage and infection.
The aim of this study is to examine whether there is an association between the method of
removal of the placenta and increase in postpartum white blood cell counts
After informed consent, all patients are randomized according to the removal of placenta from
the uterus after childbirth; manually (Group 1) or controlled cord traction without putting
hands inside the uterus (Group 2). Patients are examined regarding to maternal infection. BMI
measurement, obstetrics and medical history are recorded. The operative procedures are
similar in all patients and followed the same technical steps. In both groups, oxytocin and a
first-generation cephalosporin antibiotic are administered intravenously after the delivery
of the infant. All uterine incisions were low transverse and all were closed without
exteriorisation of the uterus. Complete blood count before delivery, on pastpartum day 1 and
2, fever during hospitalisation, average blood loss during operation and the endometritis
cases are recorded. All the patients are asked to come to control on postpartum day 10. Also,
patients are asked to come to control if they have fever, abnormal vaginal bleeding, abnormal
vaginal discharge, general feeling of sickness and pain in the pelvis. Fever is defined as a
temperature above 38.5°C on two consecutive days, excluding the first 24 hours.
