Placental TransfusionPhase 3NCT02618499
Delayed Cord Clamping and Use of Oxytocin
A Phase 3 study testing Timing of administration of post partum Oxytocin in people with Placental Transfusion, run by Fundacion para la Salud Materno Infantil at 1 site in Argentina.
Trial summary
The purpose of this study is to determine if oxytocin administration immediately after delivery of the infant modifies the volume of placental transfusion in healthy term infants. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Placental Transfusion
- What is being tested?
- Timing of administration of post partum Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteArgentina
- Study dates
- May 2016to Nov 2016
- Phase
- Phase 3
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Healthy single Term pregnancies.
- Vaginal delivery.
- Informed consent obtained.
- Presence of an investigator
Who cannot join
- Placenta previa.
- Previous history of Postpartum hemorrhage
- Intrauterine growth restriction .
- Major congenital malformations.
- Eclampsia
- Extraction of blood sample for bank of umbilical cord stem cells.
Show all 13Show fewer
- Elimination criteria:
- Need for immediate assistance of the newborn
- Birth weight less than 2500 g
- Nuchal cord wrapped too tight
- Surgically finished delivery
- Short umbilical cord which might prevent placing the infant on the scale
- Technical difficulties to obtain the weight
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Instituto de Ginecologia y Maternidad Nuestra Señora de la Merced
San Miguel de Tucumán, Tucumán Province
About this study
Official title: Is Placental Transfusion Influenced by the Early Administration of Oxytocin?
The purpose of this study is to determine if oxytocin administration immediately after delivery of the infant modifies the volume of placental transfusion in healthy term infants.
Read the detailed description
Randomized controlled trial with 2 arms to test the influence of oxytocin in placental transfusion.
Placental transfusion: the amount of blood that passes to the baby from the time of birth until the cord is clamped.
The difference in weight between a measurement at birth and a second one after clamping the cord at 3 minutes will be considered as proxy for placental transfusion.
In one arm the oxytocin will be used immediately after birth and the cord clamped at 3 minutes In the other arm the oxytocin will be administered at 3 minutes of birth after the cord is clamped.
- Conditions
- Placental Transfusion
- Being tested
- Timing of administration of post partum Oxytocin
- Keywords
- birth, oxytocin, placental transfusion, umbilical cord clamping
- Medical subject headings
- Fetofetal Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timing of administration of post partum OxytocinDrug
Also called syntosinon
10 IU of oxytocin given IV at different times after birth
| Study group | Role | What they receive |
|---|---|---|
| oxytocin inmediately at birth | Active comparator | Intervention: Timing of administration of postpartum Oxytocin. 10 international Units (IU) immediately at birth will be given intravenously (IV) to the mother. Receives: Drug: Timing of administration of post partum Oxytocin |
| oxytocin at 3 minutes | Experimental | Intervention: Timing of administration of postpartum Oxytocin. 10 IU IV at 3 minutes immediately after the cord is clamped Receives: Drug: Timing of administration of post partum Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
placental transfusion
Difference in body weight between birth and 3 minutes of life
Measured: between birth and 3 minutes of life
Secondary outcomes (3)
bilirubin
Bilirubin level
Measured: at 36/48 hours
Hematocrit
Hematocrit levels
Measured: at 36/48 hours
Maternal blood loss
measure of the blood loss
Measured: after birth for 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startMay 2016
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: Futility suggested by DSMC
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Placental TransfusionStudies 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Salud Materno Infantil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nestor Vain, MD, Study director, FundasaminDaniela S Satragno, MD, Principal investigator, Fundasamin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618499
- Sponsor's protocol ID
- Funda05
- Status last verified
- Nov 2016
- First submitted
- 10 Nov 2015
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
McDonald SJ, Middleton P, Dowswell T, Morris PS. Effect of timing of umbilical cord clamping of term infants on maternal and neonatal outcomes. Cochrane Database Syst Rev. 2013 Jul 11;2013(7):CD004074. doi: 10.1002/14651858.CD004074.pub3.
PubMed 23843134Vain NE, Satragno DS, Gorenstein AN, Gordillo JE, Berazategui JP, Alda MG, Prudent LM. Effect of gravity on volume of placental transfusion: a multicentre, randomised, non-inferiority trial. Lancet. 2014 Jul 19;384(9939):235-40. doi: 10.1016/S0140-6736(14)60197-5. Epub 2014 Apr 17.
PubMed 24746755Westhoff G, Cotter AM, Tolosa JE. Prophylactic oxytocin for the third stage of labour to prevent postpartum haemorrhage. Cochrane Database Syst Rev. 2013 Oct 30;(10):CD001808. doi: 10.1002/14651858.CD001808.pub2.
PubMed 24173606Lalonde A; International Federation of Gynecology and Obstetrics. Prevention and treatment of postpartum hemorrhage in low-resource settings. Int J Gynaecol Obstet. 2012 May;117(2):108-18. doi: 10.1016/j.ijgo.2012.03.001. No abstract available.
PubMed 22502595Soltani H, Hutchon DR, Poulose TA. Timing of prophylactic uterotonics for the third stage of labour after vaginal birth. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD006173. doi: 10.1002/14651858.CD006173.pub2.
PubMed 20687079Begley CM, Gyte GM, Devane D, McGuire W, Weeks A. Active versus expectant management for women in the third stage of labour. Cochrane Database Syst Rev. 2015 Mar 2;(3):CD007412. doi: 10.1002/14651858.CD007412.pub4.
PubMed 25730178Yao AC, Hirvensalo M, Lind J. Placental transfusion-rate and uterine contraction. Lancet. 1968 Feb 24;1(7539):380-3. doi: 10.1016/s0140-6736(68)91352-4. No abstract available.
PubMed 4169972Farrar D, Airey R, Law GR, Tuffnell D, Cattle B, Duley L. Measuring placental transfusion for term births: weighing babies with cord intact. BJOG. 2011 Jan;118(1):70-5. doi: 10.1111/j.1471-0528.2010.02781.x. Epub 2010 Nov 18.
PubMed 21083868Trudnowski RJ, Rico RC. Specific gravity of blood and plasma at 4 and 37 degrees C. Clin Chem. 1974 May;20(5):615-6. No abstract available.
PubMed 4826961Vain NE, Satragno DS, Gordillo JE, Fernandez AL, Carrolli G, Romero NP, Prudent LM. Postpartum use of oxytocin and volume of placental transfusion: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2020 Jan;105(1):14-17. doi: 10.1136/archdischild-2018-316649. Epub 2019 May 9.
PubMed 31072967
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Placental Transfusion Influenced by the Early Administration of Oxytocin?
- ClinicalTrials.gov ID
- NCT02618499
- Acronym / sponsor ID
- Funda05
- Conditions
- Placental Transfusion
- Keywords
- birth, oxytocin, placental transfusion, umbilical cord clamping
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility suggested by DSMC
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Fundacion para la Salud Materno InfantilUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 1 Dec 2015 (estimated)
- 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 purpose of this study is to determine if oxytocin administration immediately after delivery of the infant modifies the volume of placental transfusion in healthy term infants.
Detailed description
Randomized controlled trial with 2 arms to test the influence of oxytocin in placental transfusion.
Placental transfusion: the amount of blood that passes to the baby from the time of birth until the cord is clamped.
The difference in weight between a measurement at birth and a second one after clamping the cord at 3 minutes will be considered as proxy for placental transfusion.
In one arm the oxytocin will be used immediately after birth and the cord clamped at 3 minutes In the other arm the oxytocin will be administered at 3 minutes of birth after the cord is clamped.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxytocin inmediately at birth | Active comparator | Drug: Timing of administration of post partum OxytocinIntervention: Timing of administration of postpartum Oxytocin. 10 international Units (IU) immediately at birth will be given intravenously (IV) to the mother. |
| oxytocin at 3 minutes | Experimental | Drug: Timing of administration of post partum OxytocinIntervention: Timing of administration of postpartum Oxytocin. 10 IU IV at 3 minutes immediately after the cord is clamped |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy single Term pregnancies.
- Vaginal delivery.
- Informed consent obtained.
- Presence of an investigator
Key exclusion criteria (13 listed)
- Placenta previa.
- Previous history of Postpartum hemorrhage
- Intrauterine growth restriction .
- Major congenital malformations.
- Eclampsia
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 |
|---|---|---|
| Timing of administration of post partum OxytocinAlso: syntosinon10 IU of oxytocin given IV at different times after birth | Drug | oxytocin at 3 minutes, oxytocin inmediately at birth |
Primary outcome
placental transfusion
Time frame: between birth and 3 minutes of life
Difference in body weight between birth and 3 minutes of life
3 secondary outcomes
bilirubin
Time frame: at 36/48 hours
Hematocrit
Time frame: at 36/48 hours
Maternal blood loss
Time frame: after birth for 30 minutes
Results and safety
The study was stopped early (reason given: Futility suggested by DSMC). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2016.
- Background: PubMed 23843134McDonald SJ, Middleton P, Dowswell T, Morris PS. Effect of timing of umbilical cord clamping of term infants on maternal and neonatal outcomes. Cochrane Database Syst Rev. 2013 Jul 11;2013(7):CD004074. doi: 10.1002/14651858.CD004074.pub3.
- Background: PubMed 24746755Vain NE, Satragno DS, Gorenstein AN, Gordillo JE, Berazategui JP, Alda MG, Prudent LM. Effect of gravity on volume of placental transfusion: a multicentre, randomised, non-inferiority trial. Lancet. 2014 Jul 19;384(9939):235-40. doi: 10.1016/S0140-6736(14)60197-5. Epub 2014 Apr 17.
- Background: PubMed 24173606Westhoff G, Cotter AM, Tolosa JE. Prophylactic oxytocin for the third stage of labour to prevent postpartum haemorrhage. Cochrane Database Syst Rev. 2013 Oct 30;(10):CD001808. doi: 10.1002/14651858.CD001808.pub2.
- Background: PubMed 22502595Lalonde A; International Federation of Gynecology and Obstetrics. Prevention and treatment of postpartum hemorrhage in low-resource settings. Int J Gynaecol Obstet. 2012 May;117(2):108-18. doi: 10.1016/j.ijgo.2012.03.001. No abstract available.
- Background: PubMed 20687079Soltani H, Hutchon DR, Poulose TA. Timing of prophylactic uterotonics for the third stage of labour after vaginal birth. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD006173. doi: 10.1002/14651858.CD006173.pub2.
- Background: PubMed 25730178Begley CM, Gyte GM, Devane D, McGuire W, Weeks A. Active versus expectant management for women in the third stage of labour. Cochrane Database Syst Rev. 2015 Mar 2;(3):CD007412. doi: 10.1002/14651858.CD007412.pub4.
- Background: PubMed 4169972Yao AC, Hirvensalo M, Lind J. Placental transfusion-rate and uterine contraction. Lancet. 1968 Feb 24;1(7539):380-3. doi: 10.1016/s0140-6736(68)91352-4. No abstract available.
- Background: PubMed 21083868Farrar D, Airey R, Law GR, Tuffnell D, Cattle B, Duley L. Measuring placental transfusion for term births: weighing babies with cord intact. BJOG. 2011 Jan;118(1):70-5. doi: 10.1111/j.1471-0528.2010.02781.x. Epub 2010 Nov 18.
- Background: PubMed 4826961Trudnowski RJ, Rico RC. Specific gravity of blood and plasma at 4 and 37 degrees C. Clin Chem. 1974 May;20(5):615-6. No abstract available.
- Derived from this study: PubMed 31072967Vain NE, Satragno DS, Gordillo JE, Fernandez AL, Carrolli G, Romero NP, Prudent LM. Postpartum use of oxytocin and volume of placental transfusion: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2020 Jan;105(1):14-17. doi: 10.1136/archdischild-2018-316649. Epub 2019 May 9.
- WHO recommendationsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Nestor Vain, MD study director
Fundasamin
Daniela S Satragno, MD principal investigator
Fundasamin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Timing of administration of post partum Oxytocin in people with Placental Transfusion, run by Fundacion para la Salud Materno Infantil at 1 site in Argentina.
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 13 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: stopped early, as of the sponsor's last update on 23 Nov 2016. 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 Argentina. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Futility suggested by DSMC). Results are not available in the source record.
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?
placental transfusion (time frame: between birth and 3 minutes of life). 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 NCT02618499, which also lists 10 linked publications.
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 23 Nov 2016.