An interventional study of Controlled cord traction in Cesarean Section Complications, sponsored by Haydarpasa Numune Training and Research Hospital. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-04.
Sponsored by Haydarpasa Numune Training and Research Hospital · Not applicable, Interventional, and Prevention
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.
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.
Haydarpasa Numune Training and Research Hospital is the lead sponsor of 32 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In group 1, plasenta is removed manually. Manual removal of the placenta will be performed by placing surgeon's dominant hand in the uterine cavity and removing the placenta by detaching it from the uterine wall as soon as possible after the delivery of the infant. The emptiness of the uterine cavity is verified manually.
In group 2, plasenta is removed by controlled cord traction. Spontaneous removal will be performed by external uterine massage and traction on the umbilical cord are performed to assist spontaneous delivery of the placenta.
Other: Controlled cord traction
In group 2, Spontaneous removal will be performed by massaging on the uterine fundus and applying gentle traction on the umbilical cord.
Change from Baseline Leukocyte Level at Postpartum Day 1
Measurement of complete blood count
Time frame: Before delivery and postpartum day 1
Detection of Leukocyte Count
Measurement of complete blood count
Time frame: Postpartum day 2
Detection of Number of Patients with Fever
Body temperature is measured 4 times in a day. Highest temparature will be record on postpartum day 1.
Time frame: On postpartum day 1
Detection of Number of Patients with Fever
Body temperature is measured 4 times in a day. Highest temparature will be record on postpartum day 2.
Time frame: On postpartum day 2
Number of Participants with Postpartum Endometritis
All the patients are asked to come to control on postpartum day 7. 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.
Time frame: Postpartum day 10
Measurement of average blood loss during caesarean section by change from baseline hematocrit level at postpartum day 1.
Measurement of hematocrit level
Time frame: Before operation and postpartum day 1
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Plan to share: No
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Leukocytosis
Haydarpasa Numune Training and Research Hospital