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

Samsun Education and Research Hospital

Status: Completed

Conditions: Indications for Care in Pregnancy; Labor; and Delivery

Treatments: Other: The calculation of blood IL-6 and coloctral milk melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT03953066

SamsunERH-1

Details and patient eligibility

About

The comparison of serum and colostral melatonin, and IL-6 levels between women with vaginal delivery, emergency cesarean section and elective cesarean section

Full 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

Enrollment: 90 patients

Sex: Female

Ages: 18 to 36 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

women with vaginal delivery

Active Comparator group

Description:

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

Treatment:

Other: The calculation of blood IL-6 and coloctral milk melatonin

women with emergency cesarean section

Active Comparator group

Description:

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

Treatment:

Other: The calculation of blood IL-6 and coloctral milk melatonin

women with elective cesarean section

Active Comparator group

Description:

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

Treatment:

Other: The calculation of blood IL-6 and coloctral milk melatonin