The Comparison of Serum and Colostral Melatonin, and IL-6 Levels Between Women With Vaginal Delivery, Emergency Cesarean Section and Elective Cesarean Section
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- The serum IL-6 level
Study 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
- •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
- •Thyroid diseases
- •Patients with chronic diseases
- •Drug users
Arms & Interventions
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
Intervention: The calculation of blood IL-6 and coloctral milk melatonin (Other)
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
Intervention: The calculation of blood IL-6 and coloctral milk melatonin (Other)
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
Intervention: The calculation of blood IL-6 and coloctral milk melatonin (Other)
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
canan soyer çalışkan
MD
Samsun Education and Research Hospital