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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Indications for Care in Pregnancy; Labor; and Delivery

Intervention / Treatment
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* Other: The calculation of blood IL-6 and coloctral milk melatonin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 36 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: women with vaginal delivery<br>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<br>* 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<br>* Other names: No other intervention;|
| Active Comparator: women with emergency cesarean section<br>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<br>* 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<br>* Other names: No other intervention;|
| Active Comparator: women with elective cesarean section<br>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<br>* 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<br>* Other names: No other intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The serum IL-6 level | the measurement of serum IL-6 level in blood | 8 weeks | 
| Colostral Milk melatonin levels in different types of deliveries | Colostral milk taken from the postpartum midnight breast milk were evaluated for melatonin levels | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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melatonin,colostral milk,IL-6, delivery, cesarean section