Association of Placenta Removal Method and Postpartum Leucocytosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Placenta Removal Method On Postpartum Leucocytosis : A Randomized Controlled Trial

Conditions
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Cesarean Section Complications

Intervention / Treatment
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* Other: Controlled cord traction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>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. | |
| Experimental: Study Group<br>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<br>* In group 2, Spontaneous removal will be performed by massaging on the uterine fundus and applying gentle traction on the umbilical cord.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Leukocyte Level at Postpartum Day 1 | Measurement of complete blood count | Before delivery and postpartum day 1 | 
| Detection of Leukocyte Count | Measurement of complete blood count | 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. | 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. | 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. | Postpartum day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of average blood loss during caesarean section by change from baseline hematocrit level at postpartum day 1. | Measurement of hematocrit level | Before operation and postpartum day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Placenta removal method, postpartum leucocytosis, endometritis, postpartum anemia