Colostral Milk and Blood IL-6 Levels in Types of Labour
The Comparison of Serum and Colostral Melatonin, and IL-6 Levels Between Women With Vaginal Delivery, Emergency Cesarean Section and Elective Cesarean Section
1 other identifier
interventional
90
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2019
CompletedFirst Posted
Study publicly available on registry
May 16, 2019
CompletedStudy Start
First participant enrolled
June 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2019
CompletedSeptember 20, 2019
September 1, 2019
2 months
April 11, 2019
September 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (3)
women with vaginal delivery
ACTIVE COMPARATOR30 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 emergency cesarean section
ACTIVE COMPARATOR30 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
women with elective cesarean section
ACTIVE COMPARATOR30 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
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Women who had history of intrauterine fetal loss
- Hypertention during pregnancy
- Anemia
- Thyroid diseases
- Patients with chronic diseases
- Smokers
- Drug users
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsun EAH
Samsun, Outside of the US, 55080, Turkey (Türkiye)
Study Officials
- PRINCIPAL INVESTIGATOR
Canan Soyer-Caliskan
Samsun EAH
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
April 11, 2019
First Posted
May 16, 2019
Study Start
June 12, 2019
Primary Completion
August 12, 2019
Study Completion
August 20, 2019
Last Updated
September 20, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share