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Completed

NCT Number: NCT03953066

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

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Key information

Conditions

Indications for Care in Pregnancy; Labor; and Delivery

Age range

18 year–36 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Samsun EAH

Samsun, Outside of the US, 55080, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The calculation of blood IL-6 and coloctral milk melatonin

Other

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

Other names: No other intervention

Primary outcomes

  1. The serum IL-6 level

    Time frame: 8 weeks

    the measurement of serum IL-6 level in blood

  2. 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

Sponsors and collaborators

Lead sponsor

Samsun Education and Research Hospital

Other

Registry information

Official study title

The Comparison of Serum and Colostral Melatonin, and IL-6 Levels Between Women With Vaginal Delivery, Emergency Cesarean Section and Elective Cesarean Section

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 16, 2019
Registry last updated
Sep 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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