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Colostral Milk and Blood IL-6 Levels in Types of Labour

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ClinicalTrials.gov Identifier: NCT03953066
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
canan soyer çalışkan, Samsun Education and Research Hospital

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

Condition or disease Intervention/treatment Phase
Indications for Care in Pregnancy; Labor; and Delivery Other: The calculation of blood IL-6 and coloctral milk melatonin Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: The Comparison of Serum and Colostral Melatonin, and IL-6 Levels Between Women With Vaginal Delivery, Emergency Cesarean Section and Elective Cesarean Section
Estimated Study Start Date : June 12, 2019
Estimated Primary Completion Date : August 12, 2019
Estimated Study Completion Date : August 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section
Drug Information available for: Melatonin

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 Name: 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 Name: 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 Name: No other intervention




Primary Outcome Measures :
  1. The serum IL-6 level [ Time Frame: 8 weeks ]
    the measurement of serum IL-6 level in blood

  2. 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



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Ages Eligible for Study:   18 Years to 36 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

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Responsible Party: canan soyer çalışkan, MD, Samsun Education and Research Hospital
ClinicalTrials.gov Identifier: NCT03953066     History of Changes
Other Study ID Numbers: SamsunERH-1
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by canan soyer çalışkan, Samsun Education and Research Hospital:
melatonin,colostral milk,IL-6, delivery, cesarean section

Additional relevant MeSH terms:
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Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants