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Association of Placenta Removal Method and Postpartum Leucocytosis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04323241
Enrollment
300
Registered
2020-03-26
Start date
2019-10-01
Completion date
2021-01-20
Last updated
2021-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section Complications

Keywords

Placenta removal method, postpartum leucocytosis, endometritis, postpartum anemia

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.

Interventions

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

Sponsors

Haydarpasa Numune Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Masking description

Investigator will not know the interventional group.

Intervention 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).

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline Leukocyte Level at Postpartum Day 1Before delivery and postpartum day 1Measurement of complete blood count
Detection of Leukocyte CountPostpartum day 2Measurement of complete blood count
Detection of Number of Patients with FeverOn postpartum day 1Body temperature is measured 4 times in a day. Highest temparature will be record on postpartum day 1.
Number of Participants with Postpartum EndometritisPostpartum day 10All 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

MeasureTime frameDescription
Measurement of average blood loss during caesarean section by change from baseline hematocrit level at postpartum day 1.Before operation and postpartum day 1Measurement of hematocrit level

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026