Colostral Milk and Blood IL-6 Levels in Types of Labour
September 19, 2019 updated by: canan soyer çalışkan, Samsun Education and Research Hospital
The Comparison of Serum and Colostral Melatonin, and IL-6 Levels Between Women With Vaginal Delivery, Emergency Cesarean Section and Elective Cesarean Section
The comparison of serum and colostral melatonin, and IL-6 levels between women with vaginal delivery, emergency cesarean section and elective cesarean section
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Outside Of The US
-
Samsun, Outside Of The US, Turkey, 55080
- Samsun EAH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 36 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria
- Pregnant women reached term
- Patients with spontaneous vaginal delivery
- Patients preferred cesarean section electively
- Patient who had emergency cesarean section without additional medical or surgical problems
Exclusion Criteria
- Women who had history of intrauterine fetal loss
- Hypertention during pregnancy
- Anemia
- Thyroid diseases
- Patients with chronic diseases
- Smokers
- Drug users
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: women with vaginal delivery
30 women with spontaneous vaginal delivery will be included in group 1 serum IL-6 levels before and after delivery and colostral milk melatonin levels will be measured
|
Collected maternal colostral milk will be sampled for melatonin levels.Blood samples driven before and after delivery will be evaluated for IL-6 levels in each group
Other Names:
|
|
Active Comparator: women with emergency cesarean section
30 women with emergency cesarean section will be included in group 2 serum IL-6 levels before and after delivery and colostral milk melatonin levels will be measured
|
Collected maternal colostral milk will be sampled for melatonin levels.Blood samples driven before and after delivery will be evaluated for IL-6 levels in each group
Other Names:
|
|
Active Comparator: women with elective cesarean section
30 women with elective cesarean section will be included in group 3serum IL-6 levels before and after delivery and colostral milk melatonin levels will be measured
|
Collected maternal colostral milk will be sampled for melatonin levels.Blood samples driven before and after delivery will be evaluated for IL-6 levels in each group
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The serum IL-6 level
Time Frame: 8 weeks
|
the measurement of serum IL-6 level in blood
|
8 weeks
|
|
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
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Canan Soyer-Caliskan, Samsun EAH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 12, 2019
Primary Completion (Actual)
August 12, 2019
Study Completion (Actual)
August 20, 2019
Study Registration Dates
First Submitted
April 11, 2019
First Submitted That Met QC Criteria
May 15, 2019
First Posted (Actual)
May 16, 2019
Study Record Updates
Last Update Posted (Actual)
September 20, 2019
Last Update Submitted That Met QC Criteria
September 19, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SamsunERH-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.