Indications for Care in Pregnancy; Labor; and DeliveryNCT03953066
Colostral Milk and Blood IL-6 Levels in Types of Labour
A study testing The calculation of blood IL-6 and coloctral milk melatonin in people with Indications for Care in Pregnancy; Labor; and Delivery, run by Samsun Education and Research Hospital at 1 site in Turkey (Türkiye).
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 Read more about this study
- Who is it for?
- Ages 18 to 36 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Indications for Care in Pregnancy; Labor; and Delivery
- What is being tested?
- The calculation of blood IL-6 and coloctral milk melatonin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jun 2019to 20 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 36 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Women who had history of intrauterine fetal loss
- Hypertention during pregnancy
- Anemia
- Thyroid diseases
- Patients with chronic diseases
- Smokers
- Drug users
Trial locations and contacts
1 site in 1 country.
About this study
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
The comparison of serum and colostral melatonin, and IL-6 levels between women with vaginal delivery, emergency cesarean section and elective cesarean section
Read the 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
- Being tested
- The calculation of blood IL-6 and coloctral milk melatonin
- Keywords
- melatonin,colostral milk,IL-6, delivery, cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The calculation of blood IL-6 and coloctral milk melatoninOther
Also called No other intervention
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
| Study group | Role | What they receive |
|---|---|---|
| women with vaginal delivery | Active comparator | 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 Receives: Other: The calculation of blood IL-6 and coloctral milk melatonin |
| women with emergency cesarean section | Active comparator | 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 Receives: Other: The calculation of blood IL-6 and coloctral milk melatonin |
| women with elective cesarean section | Active comparator | 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 Receives: Other: The calculation of blood IL-6 and coloctral milk melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The serum IL-6 level
the measurement of serum IL-6 level in blood
Measured: 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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start12 Jun 2019
- Primary completion12 Aug 2019
- Study completion20 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indications for Care in Pregnancy; Labor; and DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, canan soyer çalışkan, Samsun Education and Research Hospital
- Investigators
- Canan Soyer-Caliskan, Principal investigator, Samsun EAH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953066
- Sponsor's protocol ID
- SamsunERH-1
- Status last verified
- Sep 2019
- First submitted
- 11 Apr 2019
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03953066
- Acronym / sponsor ID
- SamsunERH-1
- Keywords
- melatonin,colostral milk,IL-6, delivery, cesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Samsun Education and Research HospitalUniversity, hospital or other
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 12 Aug 2019 (actual)
- Study completion
- 20 Aug 2019 (actual)
- First posted
- 16 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| women with vaginal delivery | Active comparator | Other: The calculation of blood IL-6 and coloctral milk melatonin30 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 comparator | Other: The calculation of blood IL-6 and coloctral milk melatonin30 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 comparator | Other: The calculation of blood IL-6 and coloctral milk melatonin30 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 |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Women who had history of intrauterine fetal loss
- Hypertention during pregnancy
- Anemia
- Thyroid diseases
- Patients with chronic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The calculation of blood IL-6 and coloctral milk melatoninAlso: No other interventionCollected 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 | women with elective cesarean section, women with emergency cesarean section, women with vaginal delivery |
Primary outcome
The serum IL-6 level
Time frame: 8 weeks
the measurement of serum IL-6 level in blood
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Canan Soyer-Caliskan principal investigator
Samsun EAH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The calculation of blood IL-6 and coloctral milk melatonin in people with Indications for Care in Pregnancy; Labor; and Delivery, run by Samsun Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The serum IL-6 level (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.