Third Stage of LaborNCT04463485
Impact of Umbilical Cord Clamping Time on Infant Anemia
A study testing Delayed Clamping in people with Third Stage of Labor and Healthy, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
This research was conducted to carry out the effect of umbilical cord clamping time on baby anemia. Read more about this study
- Who is it for?
- Ages 19 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Third Stage of Labor, Healthy, Umbilical Cord Clamping Time
- What is being tested?
- Delayed Clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Dec 2017to 30 Dec 2018
- 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 19 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Apply for normal birth
- Singleton pregnancy and live fetus
- Cephalic presentation
- Estimated birth weight between 2500-4000 grams
- Birth rates <5
- Women who received iron support during pregnancy
Show all 10Show fewer
- Haemoglobin level ≥ 11 gr/dL
- No systemic disease or pregnancy complication that may pose a risk for postpartum bleeding.
- Neonates who don't need for resuscitation after birth
- Babies who did not receive iron supplements up to the 4th month after birth were included.
Who cannot join
- Pregnant women who refuse to participate in the research
- Neonates who need for resuscitation after birth
- Babies who receive iron supplements up to the 4th month after birth were excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Medical Hospital Obstetric and Gynecology Department
Izmir, 35100
About this study
This research was conducted to carry out the effect of umbilical cord clamping time on baby anemia.
Read the detailed description
This study is an experimental, randomized controlled study. The sample of the study consisted of 65 pregnant women and newborns (intervention=32, control=33) who applied for delivery at Ege University Medical Hospital Gynecology and Obstetrics Clinic at the time of the study. In this study, "Descriptive Data Form of Impact of Umbilical Cord Clamping Time on Infant Anemia" was used as a data collection tool. In the intervention group waited 60 seconds for umbilical cord clamping in the second stage of labor, in the control group the umbilical cord was clamped in the first 15 seconds. For the data of the first stage of the study, the neonatal hematocrit and bilirubin measurements and the need for phototherapy due to hyperbilirubinemia were evaluated 48 hours after birth. In the second stage of the study, data on anaemia screening performed in family medicine at the end of the fourth month of birth were examined. Statistical analysis of the data from the study was performed using IBM SPSS Statistics 25.0 package program. Parametric tests were used for statistical analysis of the data with a normal distribution. The level of statistical significance was determined as p<0.05.
- Being tested
- Delayed Clamping
- Keywords
- umbilical cord, clamping, infant, anemia, midwifery
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed ClampingProcedure or surgery
Umbilical cord clamping was delayed 60 seconds at the end of second stage of labor.
| Study group | Role | What they receive |
|---|---|---|
| Delayed Clamping | Experimental | The intervention group was waited 60 seconds for umbilical cord clamping in the second stage of labor. Receives: Procedure: Delayed Clamping |
| Early Clamping | No intervention | No interventions have been assigned. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Haematocrit Value at 48th Hours of Life
Haematocrit measurement in capillary blood taken from newborn after birth
Measured: 48th hours after birth
Neonatal Bilirubin Value at 48th Hours of Life
Bilirubin measurement in capillary blood taken from newborn after birth
Measured: 48th hours after birth
Phototherapy Requirement Rates due to Hyperbilirubinemia
Neonatal phototherapy requirement due to hyperbilirubinemia in the postpartum period
Measured: 3 or 14 days of age
Haemoglobin Values of 4 Month Infants
Haemoglobin measurement at baby's 4th month of age
Measured: Infants' 4th month of age
Haematocrit Values of 4 Month Infants
Haematocrit measurement at baby's 4th month of age
Measured: Infants' 4th month of age
Diagnosis of Anemia Rates of 4 Month Infants
Screening of the family medicine center, condition of the baby diagnosed with anemia at 4th month of age
Measured: Infants' 4th month of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start21 Dec 2017
- Primary completion30 Aug 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Third Stage of LaborStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevil Güner, Mersin University
- Investigators
- Birsen Saydam, Study director, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463485
- Sponsor's protocol ID
- Delayed Cord Clamping RCT
- Status last verified
- Jul 2020
- First submitted
- 4 Jul 2020
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Umbilical Cord Clamping Time on Infant Anemia
- ClinicalTrials.gov ID
- NCT04463485
- Acronym / sponsor ID
- Delayed Cord Clamping RCT
- Keywords
- umbilical cord, clamping, infant, anemia, midwifery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 21 Dec 2017 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 9 Jul 2020 (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.
This research was conducted to carry out the effect of umbilical cord clamping time on baby anemia.
Detailed description
This study is an experimental, randomized controlled study. The sample of the study consisted of 65 pregnant women and newborns (intervention=32, control=33) who applied for delivery at Ege University Medical Hospital Gynecology and Obstetrics Clinic at the time of the study. In this study, "Descriptive Data Form of Impact of Umbilical Cord Clamping Time on Infant Anemia" was used as a data collection tool. In the intervention group waited 60 seconds for umbilical cord clamping in the second stage of labor, in the control group the umbilical cord was clamped in the first 15 seconds. For the data of the first stage of the study, the neonatal hematocrit and bilirubin measurements and the need for phototherapy due to hyperbilirubinemia were evaluated 48 hours after birth. In the second stage of the study, data on anaemia screening performed in family medicine at the end of the fourth month of birth were examined. Statistical analysis of the data from the study was performed using IBM SPSS Statistics 25.0 package program. Parametric tests were used for statistical analysis of the data with a normal distribution. The level of statistical significance was determined as p<0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed Clamping | Experimental | Procedure: Delayed ClampingThe intervention group was waited 60 seconds for umbilical cord clamping in the second stage of labor. |
| Early Clamping | No intervention | –No interventions have been assigned. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Apply for normal birth
- Singleton pregnancy and live fetus
- Cephalic presentation
- Estimated birth weight between 2500-4000 grams
- Birth rates <5
Key exclusion criteria (3 listed)
- Pregnant women who refuse to participate in the research
- Neonates who need for resuscitation after birth
- Babies who receive iron supplements up to the 4th month after birth were excluded.
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 |
|---|---|---|
| Delayed ClampingUmbilical cord clamping was delayed 60 seconds at the end of second stage of labor. | Procedure or surgery | Delayed Clamping |
Primary outcome
Neonatal Haematocrit Value at 48th Hours of Life
Time frame: 48th hours after birth
Haematocrit measurement in capillary blood taken from newborn after birth
Neonatal Bilirubin Value at 48th Hours of Life
Time frame: 48th hours after birth
Bilirubin measurement in capillary blood taken from newborn after birth
Phototherapy Requirement Rates due to Hyperbilirubinemia
Time frame: 3 or 14 days of age
Neonatal phototherapy requirement due to hyperbilirubinemia in the postpartum period
Haemoglobin Values of 4 Month Infants
Time frame: Infants' 4th month of age
Haemoglobin measurement at baby's 4th month of age
Haematocrit Values of 4 Month Infants
Time frame: Infants' 4th month of age
Haematocrit measurement at baby's 4th month of age
Diagnosis of Anemia Rates of 4 Month Infants
Time frame: Infants' 4th month of age
Screening of the family medicine center, condition of the baby diagnosed with anemia at 4th month of age
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 10 Jul 2020.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Active, not recruitingObservational study
Intact Cord Placental Delivery vs Delayed Cord Clamping
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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.
Birsen Saydam study director
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delayed Clamping in people with Third Stage of Labor and Healthy, run by Mersin University 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 10 inclusion and 3 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 10 Jul 2020. 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?
Neonatal Haematocrit Value at 48th Hours of Life (time frame: 48th hours after birth). The study lists 6 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 10 Jul 2020.