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

Not Applicable

Completed

• Conditions: Indications for Care in Pregnancy; Labor; and Delivery
• Interventions: Other: The calculation of blood IL-6 and coloctral milk melatonin

• Registration Number: NCT03953066
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2019-04-11
• Study First Submitted QC: 2019-05-15
• Study First Posted: 2019-05-16
• Study Start: 2019-06-12
• Primary Completion: 2019-08-12
• Study Completion: 2019-08-20
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-19
• Last Update Posted: 2019-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
women with vaginal delivery	The calculation of blood IL-6 and coloctral milk melatonin	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
women with elective cesarean section	The calculation of blood IL-6 and coloctral milk melatonin	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
women with emergency cesarean section	The calculation of blood IL-6 and coloctral milk melatonin	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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Samsun EAH; 🇹🇷 Samsun, Outside Of The US, Turkey