The Effect of Placenta Removal Method On Postpartum Leucocytosis : A Randomized Controlled Trial
Phase: NA
Conditions: Cesarean Section Complications
Sponsor: Haydarpasa Numune Training and Research Hospital

ASSOCIATION OF PLACENTA REMOVAL METHOD AND 
POSTPARTUM LEUCOCYTOSIS 
 
HNEAH KAEK 2019/KK/10 
March 2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

STUDY PROTOCOL 
 
OBJECTIVES 
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 
 
DESIGN 
 
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. All the patients are asked to come 
to control on postpartum day 10. 
 
 
METHODS 
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. 

 
No Intervention: control group 
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 
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.  
Primary Outcome Measure: 
1.Change from baseline leukocyte level at postpartum day 1 
Complete blood count is measured before delivery and postpartum day 1. 
2.Detection of leukocyte count 
Complete blood count is measured on postpartum day 2. 
3.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 and 2. 
5.Number of patients 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. 
 
Secondary Outcome Measures: 
Average blood loss during cesarean section is calculated by change from baseline hematocrit 
level at postpartum day 1. 
 
Inclusion Criteria:  
18-45 years old females 
Nonanemic pregnancies 
Singleton pregnancies 
Elective cesarean sections 

 
Exclusion Criteria: 
Gestational age less than 34 weeks 
Patients having umbilical cord prolapse, 
Patients having placenta previa 
Intrapartum fever and suspected chorioamnionitis 
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 
 
 
Sample size determination formula*; 
 
   Nt2pq    
n= 
       d2(N-1)+t2pq 
 
(720)(1.96)2(0.5)(0.5) 
n= 
       (0.05)2(720-1)+(1.96)2(0.5)(0.5) 
            
The minimum number of patients to collect is 251. 
* Yamane Taro (2010), Elementary Sampling Theory, Literatür publish, 3rd Edition 

 
Statistical Analysis Plan 
The study was approved by the Ethics and Clinical Investigation Committee. Statistical 
Package for the Social Sciences (SPSS; Version 20.0, Chicago, IL, USA) will be used for 
statistical analyses. Descriptive statistics will be presented as mean ± standard deviation (SD) 
for normally distributed data, and as counts and percentages for categorical data. The 
relationship between the categorical variables will be examined using the Chi-square test and 
Fisher Exact Test. Results will be evaluated with a confidence interval of 95%, and p<0.05/ 
p<0,01 will be considered statistically significant. Kolmogorov-Smirnov test will be used for 
the assessment of the normality of data. Mann- Whitney U test will be used for the data not 
normally distributed.