Placental TransfusionNCT01497353
Placental Transfusion and Cord Clamping
A study testing Position at introitus level and position at Maternal Abdomen in people with Placental Transfusion, run by Fundacion para la Salud Materno Infantil at 3 sites in Argentina.
Trial summary
To compare the evolution of the infant's weight before delayed cord clamping (2 minutes after birth) as an indirect measure of the volume of placental transfusion in a group of healthy and fullterm newborns, placed at the level of the introitus versus another group placed on the abdomen of the mother. Read more about this study
- Who is it for?
- Ages Up to 2 minutesHealthy volunteers can take part
- Conditions the study is for
- Placental Transfusion
- What is being tested?
- Position at introitus level and position at Maternal Abdomen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 3 sitesArgentina
- Study dates
- Aug 2011to Sep 2012
- 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 Up to 2 minutes
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Term newborns
- vigorous born by vaginal delivery
- informed consent Signed.
Who cannot join
- History of Placenta previa,
- postpartum hemorrhage background,
- Multiple gestation.
- Background of IUGR prenatally diagnosed.
- Major congenital malformations diagnosed previous to delivery.
- Maternal diseases such as: eclampsia, Rh incompatibility, congestive cardiac failure.
Show all 13Show fewer
- Extraction of blood sample for bank of umbilical cord stem cells.
- Elimination criteria:
- Need for immediate assistance of the newborn,
- Birth weight less than 2500 g,
- Nuchal cord wrapped too tight,
- Major congenital malformations not diagnosed during prenatal period,
- Delivery surgically finished Short umbilical cord which might prevent placing the infant in the assigned place .
Trial locations and contacts
3 sites in 1 country.
Argentina3 sites
Sanatorio de la Trinidad Palermo
Buenos Aires, Buenos Aires F.D.
Hospital Materno Infantil de San Isidro Dr. C. Gianantonio
San Isidro, Buenos Aires
Instituto de Meternidad y ginecología Nuestra señora de las Mercedes
San Miguel de Tucumán, Tucumán Province
About this study
Official title: Is the Placental Transfusion Volume Influenced by the Position of the New Born at Birth?
To compare the evolution of the infant's weight before delayed cord clamping (2 minutes after birth) as an indirect measure of the volume of placental transfusion in a group of healthy and fullterm newborns, placed at the level of the introitus versus another group placed on the abdomen of the mother.
Read the detailed description
No inferiority, Randomized controlled trial not blind, Multicenter. Informed consent will be obtained during pregnancy or admittance and previous to birth.
Hypothesis: Placing the infant on the maternal abdomen without cord clamping during the first 2 minutes after birth does not change significantly the transfusion volume as compared to infants whose cord is clamped after 2 minutes but who are placed at the level of the introitus
Term newborns by vaginal delivery and without complications will be included. Study subjects will be assigned to two groups, both with delayed clamping,according to a sequence of random numbers generated by computer. The assignment will be done through opaque, sealed, easy opening envelopes, opening the envelope at the moment the mother enters the delivery room. Both parents and obstetric group will be then informed about which group the infant will be assigned to.
In both groups: The newborn will be immediately placed on a scale, previously set at the level of the maternal introitus to record his/her weight.
Group 1: Clamping at level of introitus: The infant will be held by the neonatologist at introitus level,immediately after the initial weight Group 2: Clamping on Maternal Abdomen: The newborn will be placed on the abdomen of the mother immediately after the first weight measurement.
In both groups:A plastic clamp will be put at approximately 1cm from the cutaneous insertion of the umbilical cord at 120 seconds after birth and then a new Weight will be obtained after clamping.
Weight differences will be evaluated when positioning the infant at the level of the introitus or on the maternal abdominal-thoracic level (at or over placental level).
- Conditions
- Placental Transfusion
- Being tested
- Position at introitus level, position at Maternal Abdomen
- Keywords
- Cord clamping, newborn, Skin contact, Placental transfusion, Delivery room
- Medical subject headings
- Fetofetal Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Position at introitus levelProcedure or surgery
After birth: Weigh at 10 + 2 sec then Held the baby at the level of introitus and Cord clamping will be performed at 120 sec then another Weigh will be obtained after clamping
position at Maternal AbdomenProcedure or surgery
After birth: Weight at 10 + 2 sec then the baby will be placed at maternal abdomen and Cord clamping will be performed at 120 sec and new Weigh will be obtained after clamping
| Study group | Role | What they receive |
|---|---|---|
| Position at introitus level | Active comparator | The newborn will be held by the neonatologist at the level of the introitus, the cord will be clamped at 2 minutes after birth. New weigh will be obtained after that. Receives: Procedure: Position at introitus level |
| Position at Maternal Abdomen | Experimental | The newborn will be placed on the abdomen and of the mother immediately after the first weigh measurement. The cord will be clamped at 2 minutes after birth . Receives: Procedure: position at Maternal Abdomen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare infant's birth weight before delayed cord clamping as an indirect measure of the volume of placental transfusion in a group of healthy fullterm newborns placed at the level of the introitus versus at the the mother's abdomen.
Every elegible and randomiced newborn will be Immediately after birth placed on a scale at the level of the introitus, and the infant's weight will be recorded at 10± 2 sec.
Group 1: The infant will be held by the neonatologist at introitus level. The cord will be clamped at 120 seconds after birth.
Group 2: The newborn will be placed on the abdomen of the mother immediately after the first weight measurement. The cord will be clamped at 120 seconds after birth.
Both groups will be weigth after the cord clamping.
Measured: inmediately after birth until 2 minutes after birth
Secondary outcomes (1)
To compare venous hematocrit and bilirubin values between the 2 groups.
venous hematocrit and bilirubin will be taken together with the sample taken for the mandatory neonatal screening.
Measured: 36-48 hs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 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, Principal investigator, Fundasamin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497353
- Sponsor's protocol ID
- funda04
- Status last verified
- Oct 2012
- First submitted
- 20 Dec 2011
- Last updated
- 19 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fonseca D. Importancia del aporte de sangre placentaria al niño recién nacido. Su medida por medio del registro ponderal continuo.Arch. Pediatr.Uruguay 1962; 7: 444
Rabe H, Reynolds G, Diaz-Rossello J. A systematic review and meta-analysis of a brief delay in clamping the umbilical cord of preterm infants. Neonatology. 2008;93(2):138-44. doi: 10.1159/000108764. Epub 2007 Sep 21.
PubMed 17890882Diaz-Rossello JL. A difficult ethics issue. Lancet. 2004 Nov 13-19;364(9447):1751-2; author reply 1752. doi: 10.1016/S0140-6736(04)17385-6. No abstract available.
PubMed 15541437Ceriani Cernadas JM, Carroli G, Pellegrini L, Otano L, Ferreira M, Ricci C, Casas O, Giordano D, Lardizabal J. The effect of timing of cord clamping on neonatal venous hematocrit values and clinical outcome at term: a randomized, controlled trial. Pediatrics. 2006 Apr;117(4):e779-86. doi: 10.1542/peds.2005-1156. Epub 2006 Mar 27.
PubMed 16567393McDonald SJ, Middleton P. Effect of timing of umbilical cord clamping of term infants on maternal and neonatal outcomes. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD004074. doi: 10.1002/14651858.CD004074.pub2.
PubMed 18425897Chaparro CM, Neufeld LM, Tena Alavez G, Eguia-Liz Cedillo R, Dewey KG. Effect of timing of umbilical cord clamping on iron status in Mexican infants: a randomised controlled trial. Lancet. 2006 Jun 17;367(9527):1997-2004. doi: 10.1016/S0140-6736(06)68889-2.
PubMed 16782490Lind J. Physiological adaptation to the placental transfusion: the eleventh blackader lecture. Can Med Assoc J. 1965 Nov 20;93(21):1091-100. No abstract available.
PubMed 5321023Hutton EK, Hassan ES. Late vs early clamping of the umbilical cord in full-term neonates: systematic review and meta-analysis of controlled trials. JAMA. 2007 Mar 21;297(11):1241-52. doi: 10.1001/jama.297.11.1241.
PubMed 17374818Yao AC, Lind J. Placental transfusion. Am J Dis Child. 1974 Jan;127(1):128-41. doi: 10.1001/archpedi.1974.02110200130021. No abstract available.
PubMed 4588934van Rheenen PF, Brabin BJ. Effect of timing of cord clamping on neonatal venous hematocrit values and clinical outcome at term: a randomized, controlled trial. Pediatrics. 2006 Sep;118(3):1317-8; author reply 1318-9. doi: 10.1542/peds.2006-1053. No abstract available.
PubMed 16951036Moore ER, Anderson GC, Bergman N. Early skin-to-skin contact for mothers and their healthy newborn infants. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003519. doi: 10.1002/14651858.CD003519.pub2.
PubMed 17636727Yao 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 4169972Yao AC, Moinian M, Lind J. Distribution of blood between infant and placenta after birth. Lancet. 1969 Oct 25;2(7626):871-3. doi: 10.1016/s0140-6736(69)92328-9. No abstract available.
PubMed 4186454Farrar 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 21083868Vain 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 24746755
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Placental Transfusion Volume Influenced by the Position of the New Born at Birth?
- ClinicalTrials.gov ID
- NCT01497353
- Acronym / sponsor ID
- funda04
- Conditions
- Placental Transfusion
- Keywords
- Cord clamping, newborn, Skin contact, Placental transfusion, Delivery room
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Fundacion para la Salud Materno InfantilUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 22 Dec 2011 (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.
To compare the evolution of the infant's weight before delayed cord clamping (2 minutes after birth) as an indirect measure of the volume of placental transfusion in a group of healthy and fullterm newborns, placed at the level of the introitus versus another group placed on the abdomen of the mother.
Detailed description
No inferiority, Randomized controlled trial not blind, Multicenter. Informed consent will be obtained during pregnancy or admittance and previous to birth.
Hypothesis: Placing the infant on the maternal abdomen without cord clamping during the first 2 minutes after birth does not change significantly the transfusion volume as compared to infants whose cord is clamped after 2 minutes but who are placed at the level of the introitus
Term newborns by vaginal delivery and without complications will be included. Study subjects will be assigned to two groups, both with delayed clamping,according to a sequence of random numbers generated by computer. The assignment will be done through opaque, sealed, easy opening envelopes, opening the envelope at the moment the mother enters the delivery room. Both parents and obstetric group will be then informed about which group the infant will be assigned to.
In both groups: The newborn will be immediately placed on a scale, previously set at the level of the maternal introitus to record his/her weight.
Group 1: Clamping at level of introitus: The infant will be held by the neonatologist at introitus level,immediately after the initial weight Group 2: Clamping on Maternal Abdomen: The newborn will be placed on the abdomen of the mother immediately after the first weight measurement.
In both groups:A plastic clamp will be put at approximately 1cm from the cutaneous insertion of the umbilical cord at 120 seconds after birth and then a new Weight will be obtained after clamping.
Weight differences will be evaluated when positioning the infant at the level of the introitus or on the maternal abdominal-thoracic level (at or over placental level).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Position at introitus level | Active comparator | Procedure: Position at introitus levelThe newborn will be held by the neonatologist at the level of the introitus, the cord will be clamped at 2 minutes after birth. New weigh will be obtained after that. |
| Position at Maternal Abdomen | Experimental | Procedure: position at Maternal AbdomenThe newborn will be placed on the abdomen and of the mother immediately after the first weigh measurement. The cord will be clamped at 2 minutes after birth . |
Who may qualify
- Ages
- Up to 2 minutes
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Term newborns
- vigorous born by vaginal delivery
- informed consent Signed.
Key exclusion criteria (13 listed)
- History of Placenta previa,
- postpartum hemorrhage background,
- Multiple gestation.
- Background of IUGR prenatally diagnosed.
- Major congenital malformations diagnosed previous to delivery.
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 |
|---|---|---|
| Position at introitus levelAfter birth: Weigh at 10 + 2 sec then Held the baby at the level of introitus and Cord clamping will be performed at 120 sec then another Weigh will be obtained after clamping | Procedure or surgery | Position at introitus level |
| position at Maternal AbdomenAfter birth: Weight at 10 + 2 sec then the baby will be placed at maternal abdomen and Cord clamping will be performed at 120 sec and new Weigh will be obtained after clamping | Procedure or surgery | Position at Maternal Abdomen |
Primary outcome
Compare infant's birth weight before delayed cord clamping as an indirect measure of the volume of placental transfusion in a group of healthy fullterm newborns placed at the level of the introitus versus at the the mother's abdomen.
Time frame: inmediately after birth until 2 minutes after birth
Every elegible and randomiced newborn will be Immediately after birth placed on a scale at the level of the introitus, and the infant's weight will be recorded at 10± 2 sec. Group 1: The infant will be held by the neonatologist at introitus level. The cord will be clamped at 120 seconds after birth. Group 2: The newborn will be placed on the abdomen of the mother immediately after the first weight measurement. The cord will be clamped at 120 seconds after birth. Both groups will be weigth after the cord clamping.
1 secondary outcome
To compare venous hematocrit and bilirubin values between the 2 groups.
Time frame: 36-48 hs
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 19 Oct 2012.
- BackgroundFonseca D. Importancia del aporte de sangre placentaria al niño recién nacido. Su medida por medio del registro ponderal continuo.Arch. Pediatr.Uruguay 1962; 7: 444
- Results publication: PubMed 17890882Rabe H, Reynolds G, Diaz-Rossello J. A systematic review and meta-analysis of a brief delay in clamping the umbilical cord of preterm infants. Neonatology. 2008;93(2):138-44. doi: 10.1159/000108764. Epub 2007 Sep 21.
- Results publication: PubMed 15541437Diaz-Rossello JL. A difficult ethics issue. Lancet. 2004 Nov 13-19;364(9447):1751-2; author reply 1752. doi: 10.1016/S0140-6736(04)17385-6. No abstract available.
- Results publication: PubMed 16567393Ceriani Cernadas JM, Carroli G, Pellegrini L, Otano L, Ferreira M, Ricci C, Casas O, Giordano D, Lardizabal J. The effect of timing of cord clamping on neonatal venous hematocrit values and clinical outcome at term: a randomized, controlled trial. Pediatrics. 2006 Apr;117(4):e779-86. doi: 10.1542/peds.2005-1156. Epub 2006 Mar 27.
- Results publication: PubMed 18425897McDonald SJ, Middleton P. Effect of timing of umbilical cord clamping of term infants on maternal and neonatal outcomes. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD004074. doi: 10.1002/14651858.CD004074.pub2.
- Results publication: PubMed 16782490Chaparro CM, Neufeld LM, Tena Alavez G, Eguia-Liz Cedillo R, Dewey KG. Effect of timing of umbilical cord clamping on iron status in Mexican infants: a randomised controlled trial. Lancet. 2006 Jun 17;367(9527):1997-2004. doi: 10.1016/S0140-6736(06)68889-2.
- Results publication: PubMed 5321023Lind J. Physiological adaptation to the placental transfusion: the eleventh blackader lecture. Can Med Assoc J. 1965 Nov 20;93(21):1091-100. No abstract available.
- Results publication: PubMed 17374818Hutton EK, Hassan ES. Late vs early clamping of the umbilical cord in full-term neonates: systematic review and meta-analysis of controlled trials. JAMA. 2007 Mar 21;297(11):1241-52. doi: 10.1001/jama.297.11.1241.
- Results publication: PubMed 4588934Yao AC, Lind J. Placental transfusion. Am J Dis Child. 1974 Jan;127(1):128-41. doi: 10.1001/archpedi.1974.02110200130021. No abstract available.
- Results publication: PubMed 16951036van Rheenen PF, Brabin BJ. Effect of timing of cord clamping on neonatal venous hematocrit values and clinical outcome at term: a randomized, controlled trial. Pediatrics. 2006 Sep;118(3):1317-8; author reply 1318-9. doi: 10.1542/peds.2006-1053. No abstract available.
- Results publication: PubMed 17636727Moore ER, Anderson GC, Bergman N. Early skin-to-skin contact for mothers and their healthy newborn infants. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003519. doi: 10.1002/14651858.CD003519.pub2.
- Results publication: 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.
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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 principal investigator
Fundasamin
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Position at introitus level and position at Maternal Abdomen in people with Placental Transfusion, run by Fundacion para la Salud Materno Infantil at 3 sites 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 3 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: finished, as of the sponsor's last update on 19 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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?
Compare infant's birth weight before delayed cord clamping as an indirect measure of the volume of placental transfusion in a group of healthy fullterm newborns placed at the level of the introitus versus at the the mother's abdomen. (time frame: inmediately after birth until 2 minutes after birth). 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 NCT01497353, which also lists 15 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 19 Oct 2012.