Association of Placenta Removal Method and Postpartum Leucocytosis

NCT04323241 | Completed

• 1 other identifier: HNEAH KAEK 2019/KK/10
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section Complications

Keywords

Placenta removal method; postpartum leucocytosis; endometritis; postpartum anemia

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

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

  Before operation and postpartum day 1

Study Arms (2)

control group

NO INTERVENTION

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.

Study Group

EXPERIMENTAL

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

Interventions

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.

Study Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Nonanemic pregnancies
• Singleton pregnancies
• Term pregnancies
• Elective cesarean sections

You may not qualify if:

• 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

Sponsors & Collaborators

• Haydarpasa Numune Training and Research Hospital: lead

Study Sites (1)

University of Health Sciences Turkey

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Endometritis

Condition Hierarchy (Ancestors)

Pelvic Inflammatory Disease; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Uterine Diseases; Genital Diseases

Study Officials

• Sevcan Arzu Arinkan, M.D.

  Haydarpasa Numune Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigator will not know the interventional group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 26, 2020
• Study Start: October 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: January 20, 2021
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)