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Clinical Trials/NCT03953066
NCT03953066
Completed
Not Applicable

The Comparison of Serum and Colostral Melatonin, and IL-6 Levels Between Women With Vaginal Delivery, Emergency Cesarean Section and Elective Cesarean Section

Samsun Education and Research Hospital1 site in 1 country90 target enrollmentStarted: June 12, 2019Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Samsun Education and Research Hospital
Enrollment
90
Locations
1
Primary Endpoint
The serum IL-6 level

Overview

Brief Summary

The comparison of serum and colostral melatonin, and IL-6 levels between women with vaginal delivery, emergency cesarean section and elective cesarean section

Detailed Description

In this prospective randomized study, the investigators aimed to show the changes in the melatonin levels in colostral milk in spontaneous vaginal delivery,emergency cesarean and elective cesarean section patients and changes in blood IL-6 level before and after the delivery in same patient groups.

the investigators randomized 30 cases for each group for comparisons.Time range seems short in this study but participating hospital setting is a busy maternity hospital thus it will be performed easily.

The purpose of this study is to demonstrate the beneficial effect of spontaneous vaginal delivery on the secretion of melatonin which is solely secreted by the mother and the newborn is dependent on maternal milk oriented melatonin until 12 th week after delivery

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 36 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

The serum IL-6 level

Time Frame: 8 weeks

the measurement of serum IL-6 level in blood

Colostral Milk melatonin levels in different types of deliveries

Time Frame: 8 weeks

Colostral milk taken from the postpartum midnight breast milk were evaluated for melatonin levels

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Samsun Education and Research Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

canan soyer çalışkan

MD

Samsun Education and Research Hospital

Study Sites (1)

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