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

Indications for Care in Pregnancy; Labor; and Delivery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03953066
• Other study ID #: SamsunERH-1
• Status: Completed
• Phase: N/A
• Start date: June 12, 2019
• Est. completion date: August 20, 2019

Study information

• Verified date: September 2019
• Source: Samsun Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 20, 2019
• Est. primary completion date: August 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 36 Years

Eligibility

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

Related Conditions & MeSH terms

• Indications for Care in Pregnancy; Labor; and Delivery

Intervention

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

Locations

Country	Name	City	State
Turkey	Samsun EAH	Samsun	Outside Of The US

Sponsors (1)

Lead Sponsor	Collaborator
Samsun Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The serum IL-6 level	the measurement of serum IL-6 level in blood	8 weeks
Primary	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