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

Conditions

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

  • Turkey
    • 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
Other: The calculation of blood IL-6 and coloctral milk melatonin
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:
  • No other intervention
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
Other: The calculation of blood IL-6 and coloctral milk melatonin
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:
  • No other intervention
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
Other: The calculation of blood IL-6 and coloctral milk melatonin
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:
  • No other intervention

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.

Sponsor

Samsun Education and Research Hospital

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

Keywords

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.

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