Association of Placenta Removal Method and Postpartum Leucocytosis

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

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications
• Intervention / Treatment: Other: Controlled cord traction

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.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • University of Health Sciences Turkey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Haydarpasa Numune Training and Research Hospital
• Investigators: Principal Investigator: Sevcan Arzu Arinkan, M.D., Haydarpasa Numune Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): January 20, 2021

Study Registration Dates

• First Submitted: March 5, 2020
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (Actual): March 26, 2020

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: endometritis; postpartum anemia; Placenta removal method; postpartum leucocytosis
• Additional Relevant MeSH Terms: Pathologic Processes; Hematologic Diseases; Leukocyte Disorders; Leukocytosis
• Other Study ID Numbers: HNEAH KAEK 2019/KK/10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No