Clinical trial NCT04323241: Association of Placenta Removal Method and Postpartum Leucocytosis
Official title: The Effect of Placenta Removal Method On Postpartum Leucocytosis : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section Complications
Keywords: Placenta removal method
postpartum leucocytosis
endometritis
postpartum anemia
Lead sponsor: Haydarpasa Numune Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The operative procedures are similar in all patients and followed the same technical steps. All patients are randomized according to the removal of placenta from the uterus after childbirth; manually removing placenta and control of endometrial cavity by fingers (Group 1) or controlled cord traction without putting fingers inside the uterus (Group 2).
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Nonanemic pregnancies
* Singleton pregnancies
* Term pregnancies
* Elective cesarean sections

Exclusion Criteria:

* Patients having umbilical cord prolapse,
* Patients having placenta previa
* Patients having preterm rupture of mebranes
* Patients having maternal infection
* Patients having multiple gestation
* Patients having antepartum hemorrhage
* Patients having severe pre-eclampsia
* Patients having placenta previa
* Patients having placental abruption
* Patients having uncontrolled gestational diabetes
* Heart disease
* Liver disorders
* Renal disorders
* Coagulopathy

Primary outcomes:
measure: Change from Baseline Leukocyte Level at Postpartum Day 1
timeFrame: Before delivery and postpartum day 1
measure: Detection of Leukocyte Count
timeFrame: Postpartum day 2
measure: Detection of Number of Patients with Fever
timeFrame: On postpartum day 1
measure: Detection of Number of Patients with Fever
timeFrame: On postpartum day 2
measure: Number of Participants with Postpartum Endometritis
timeFrame: Postpartum day 10
Secondary outcomes:
measure: Measurement of average blood loss during caesarean section by change from baseline hematocrit level at postpartum day 1.
timeFrame: Before operation and postpartum day 1
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: University of Health Sciences Turkey
Study officials:
affiliation: Haydarpasa Numune Training and Research Hospital
name: Sevcan Arzu Arinkan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: