Skip to main content
OpenTrials
Completed

NCT Number: NCT04323241

Association of Placenta Removal Method and Postpartum Leucocytosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences Turkey

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Controlled cord traction

Other

In group 2, Spontaneous removal will be performed by massaging on the uterine fundus and applying gentle traction on the umbilical cord.

Primary outcomes

  1. Change from Baseline Leukocyte Level at Postpartum Day 1

    Time frame: Before delivery and postpartum day 1

    Measurement of complete blood count

  2. Detection of Leukocyte Count

    Time frame: Postpartum day 2

    Measurement of complete blood count

  3. Detection of Number of Patients with Fever

    Time frame: On postpartum day 1

    Body temperature is measured 4 times in a day. Highest temparature will be record on postpartum day 1.

  4. Detection of Number of Patients with Fever

    Time frame: On postpartum day 2

    Body temperature is measured 4 times in a day. Highest temparature will be record on postpartum day 2.

  5. Number of Participants with Postpartum Endometritis

    Time frame: Postpartum day 10

    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 outcomes

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

    Time frame: Before operation and postpartum day 1

    Measurement of hematocrit level

Sponsors and collaborators

Lead sponsor

Haydarpasa Numune Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Mar 26, 2020
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.