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Association of Placenta Removal Method and Postpartum Leucocytosis

Primary Purpose

Cesarean Section Complications

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Controlled cord traction
Sponsored by
Haydarpasa Numune Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cesarean Section Complications focused on measuring Placenta removal method, postpartum leucocytosis, endometritis, postpartum anemia

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Health Sciences Turkey

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control group

Study Group

Arm Description

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.

Outcomes

Primary Outcome Measures

Change from Baseline Leukocyte Level at Postpartum Day 1
Measurement of complete blood count
Detection of Leukocyte Count
Measurement of complete blood count
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.
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.
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.

Secondary Outcome Measures

Measurement of average blood loss during caesarean section by change from baseline hematocrit level at postpartum day 1.
Measurement of hematocrit level

Full Information

First Posted
March 5, 2020
Last Updated
February 3, 2021
Sponsor
Haydarpasa Numune Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04323241
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
January 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Haydarpasa Numune Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section Complications
Keywords
Placenta removal method, postpartum leucocytosis, endometritis, postpartum anemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Investigator
Masking Description
Investigator will not know the interventional group.
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Study Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Controlled cord traction
Intervention Description
In group 2, Spontaneous removal will be performed by massaging on the uterine fundus and applying gentle traction on the umbilical cord.
Primary Outcome Measure Information:
Title
Change from Baseline Leukocyte Level at Postpartum Day 1
Description
Measurement of complete blood count
Time Frame
Before delivery and postpartum day 1
Title
Detection of Leukocyte Count
Description
Measurement of complete blood count
Time Frame
Postpartum day 2
Title
Detection of Number of Patients with Fever
Description
Body temperature is measured 4 times in a day. Highest temparature will be record on postpartum day 1.
Time Frame
On postpartum day 1
Title
Detection of Number of Patients with Fever
Description
Body temperature is measured 4 times in a day. Highest temparature will be record on postpartum day 2.
Time Frame
On postpartum day 2
Title
Number of Participants with Postpartum Endometritis
Description
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
Secondary Outcome Measure Information:
Title
Measurement of average blood loss during caesarean section by change from baseline hematocrit level at postpartum day 1.
Description
Measurement of hematocrit level
Time Frame
Before operation and postpartum day 1

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sevcan Arzu Arinkan, M.D.
Organizational Affiliation
Haydarpasa Numune Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Health Sciences Turkey
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Association of Placenta Removal Method and Postpartum Leucocytosis

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