Post Partum HemorrhageNCT04353544
Effect of Delayed vs Immediate Umbilical Cord Clamping on Maternal Blood Loss in Term Spontaneous Vaginal Delivery
A study testing delayed cord clamping in people with Post Partum Hemorrhage, run by Federico II University at 1 site in Italy.
Trial summary
Policies for timing of cord clamping vary, with early cord clamping generally carried out in the first 60 seconds aLer birth, whereas latercord clamping usually involves clamping the umbilical cord greater than one minute after the birth or when cord pulsation has ceased Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Post Partum Hemorrhage
- What is being tested?
- delayed cord clamping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteItaly
- Study dates
- 16 Apr 2020to 1 May 2021
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- singleton pregnancy
- at term
- cephalic presentation
- spontaneous labor
- spontaneous vaginal delivery
Who cannot join
- multiple gestation
- preterm gestation
- induced labor
- operative delivery
- hypertension or preeclampsia
- fetal anomaly
Show all 9Show fewer
- abnormal placentation
- planned cord blood banking
- maternal bleeding disorder
Trial locations and contacts
1 site in 1 country.
About this study
Policies for timing of cord clamping vary, with early cord clamping generally carried out in the first 60 seconds aLer birth, whereas latercord clamping usually involves clamping the umbilical cord greater than one minute after the birth or when cord pulsation has ceased
- Conditions
- Post Partum Hemorrhage
- Being tested
- delayed cord clamping
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
delayed cord clampingOther
delayed cord clamping
| Study group | Role | What they receive |
|---|---|---|
| Immediate cord clamping | Active comparator | Immediate cord clamping was defined as clampingwithin 15 seconds of birth Receives: Other: delayed cord clamping |
| delayed cord clamping | Experimental | when the cord stopped pulsing, or five minutes Receives: Other: delayed cord clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in maternal hemoglobin level on post delivery day 1 compared with the predelivery hemoglobin level
The primary outcome was an objective measure of maternal blood loss: the change in maternal hemoglobin level on postdelivery day 1 compared with the predelivery hemoglobin level.
Measured: day 1 after delivery
Secondary outcomes (4)
postpartum hemorrhage
defined as estimated blood loss>500cc
Measured: at the time of delivery
uterotonic administration
Measured: at the time of delivery
need for blood transfusion
Measured: at the time of delivery
jaundice
neonatal jaundice
Measured: day 10 of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start16 Apr 2020
- Primary completion25 Feb 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Partum HemorrhageStudies of the same condition, open and under way.
- More trials run by Federico II 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
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Collaborators
- Casa di Cura Accreditata Fabia Mater, Rome, Italy
- Responsible party
- Principal investigator, Gabriele Saccone, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353544
- Sponsor's protocol ID
- 1/04-18OST
- Status last verified
- Aug 2021
- First submitted
- 16 Apr 2020
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not planned
Publications
De Angelis C, Saccone G, Sorichetti E, Alagna M, Zizolfi B, Gragnano E, Legnante A, Sardo ADS. Effect of delayed versus immediate umbilical cord clamping in vaginal delivery at term: A randomized clinical trial. Int J Gynaecol Obstet. 2022 Dec;159(3):898-902. doi: 10.1002/ijgo.14223. Epub 2022 May 2.
PubMed 35428979
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Delayed vs Immediate Umbilical Cord Clamping on Maternal Blood Loss in Term Spontaneous Vaginal Delivery
- ClinicalTrials.gov ID
- NCT04353544
- Acronym / sponsor ID
- 1/04-18OST
- Conditions
- Post Partum Hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Collaborators
- Casa di Cura Accreditata Fabia Mater, Rome, Italy
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 20 Apr 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.
Policies for timing of cord clamping vary, with early cord clamping generally carried out in the first 60 seconds aLer birth, whereas latercord clamping usually involves clamping the umbilical cord greater than one minute after the birth or when cord pulsation has ceased
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate cord clamping | Active comparator | Other: delayed cord clampingImmediate cord clamping was defined as clampingwithin 15 seconds of birth |
| delayed cord clamping | Experimental | Other: delayed cord clampingwhen the cord stopped pulsing, or five minutes |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- singleton pregnancy
- at term
- cephalic presentation
- spontaneous labor
- spontaneous vaginal delivery
Key exclusion criteria (9 listed)
- multiple gestation
- preterm gestation
- induced labor
- operative delivery
- hypertension or preeclampsia
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 cord clampingdelayed cord clamping | Other | Immediate cord clamping, delayed cord clamping |
Primary outcome
change in maternal hemoglobin level on post delivery day 1 compared with the predelivery hemoglobin level
Time frame: day 1 after delivery
The primary outcome was an objective measure of maternal blood loss: the change in maternal hemoglobin level on postdelivery day 1 compared with the predelivery hemoglobin level.
4 secondary outcomes
postpartum hemorrhage
Time frame: at the time of delivery
uterotonic administration
Time frame: at the time of delivery
need for blood transfusion
Time frame: at the time of delivery
jaundice
Time frame: day 10 of life
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 24 Aug 2021.
- Derived from this study: PubMed 35428979De Angelis C, Saccone G, Sorichetti E, Alagna M, Zizolfi B, Gragnano E, Legnante A, Sardo ADS. Effect of delayed versus immediate umbilical cord clamping in vaginal delivery at term: A randomized clinical trial. Int J Gynaecol Obstet. 2022 Dec;159(3):898-902. doi: 10.1002/ijgo.14223. Epub 2022 May 2.
- Individual participant dataSharing planned: Undecided. not planned
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 cord clamping in people with Post Partum Hemorrhage, run by Federico II University at 1 site in Italy.
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 5 inclusion and 9 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 24 Aug 2021. 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 Italy. 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?
change in maternal hemoglobin level on post delivery day 1 compared with the predelivery hemoglobin level (time frame: day 1 after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04353544, which also lists 1 linked publication.
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 24 Aug 2021.