Delay Cord ClampingNCT01497340

Position at Birth,Placental Transfusion Volume and Cord Clamping

A study testing Position at introitus level and Position at Maternal Abdomen in people with Delay Cord Clamping and Placental Trasfusion, run by Fundacion para la Salud Materno Infantil at 1 site in Argentina.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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: Delay Cord Clamping, Placental Trasfusion
What is being tested?: Position at introitus level and Position at Maternal Abdomen
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteArgentina
Study dates: Oct 2010to Dec 2010
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, cephalic or vertex presentation.
Signed informed consent.

Who cannot join

History of Placenta previa,
postpartum hemorrhage background, hemorrhage before 20- week- gestation.
Multiple gestation. Background of IUGR prenatally diagnosed. Major congenital malformations diagnosed previous to delivery.
Maternal diseases such as: eclampsia, Rh incompatibility, congestive cardiac failure.
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,

Show all 9Show fewer

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

1 site in 1 country.

Argentina1 site

Hospital General de Agudos Juan A. Fernandez
Ciudad Autonoma de Buenos Aires, Buenos Aires

Other trials in Argentina

About this study

Official title: Is the Placental Transfusion Volume Influenced by the Position of the New Born at Birth? a Pilot Study

Read the detailed description

Pilot study. Randomized controlled trial not blind, in one center. 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 with cord clamping at 2 minutes after birth. 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 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 obteined after clamping.

Conditions: Delay Cord Clamping, Placental Trasfusion
Being tested: Position at introitus level, Position at Maternal Abdomen
Keywords: Cord clamping, newborn, Placental trasfusion, Delivery room

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Position at introitus levelOther
After birth: Weight at 10 + 2 sec then Held the baby at the level of introitus and Cord clamping will be performed at 120 sec Weight after clamping
Position at Maternal AbdomenOther
Newborns weight's difference between having them weighed immediately after birth and when cord is clamped in both positions(introitus and abdomen).

Study groups in NCT01497340
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 with a plastic clamp placed at 1 cm from its cutaneous insertion. Receives: Other: 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 weight measurement. The cord will be clamped at 2 minutes after birth . Receives: Other: 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 peripherical 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.

Oct 2010Dec 2010

First posted22 Dec 2011 (estimated)
Study startOct 2010
Primary completionDec 2010
Study completionDec 2010

Why it stopped: difficulties with the center

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Delay Cord ClampingStudies 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: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01497340
Sponsor's protocol ID: funda03
Status last verified: Dec 2011
First submitted: 20 Dec 2011
Last updated: 22 Dec 2011
Results posted: No

Publications

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 17890882
Diaz-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 15541437
Ceriani 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 16567393
McDonald 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 18425897
Chaparro 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 16782490
Lind 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 5321023
Hutton 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 17374818
Yao 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 4588934
van 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 16951036
Moore 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 17636727
Bystrova K, Widstrom AM, Matthiesen AS, Ransjo-Arvidson AB, Welles-Nystrom B, Wassberg C, Vorontsov I, Uvnas-Moberg K. Skin-to-skin contact may reduce negative consequences of "the stress of being born": a study on temperature in newborn infants, subjected to different ward routines in St. Petersburg. Acta Paediatr. 2003;92(3):320-6. doi: 10.1080/08035250310009248.
PubMed 12725547
Yao 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 4169972
Yao 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 4186454
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Prone Positioning During Delayed Cord Clamping
Delayed Cord Clamping
Active, not recruiting
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
IVH- Intraventricular Hemorrhage, Extreme Prematurity
Not yet recruiting
30-Second Versus Pulsation-Based Delayed Cord Clamping in Term Newborns
Umbilical Cord Clamping
Recruiting
Cord Clamping Among Neonates With Congenital Heart Disease
Congenital Heart Disease (CHD)
Enrolling by invitation
The Effect of Different Positions Given to the Newborn During Delayed Cord Clamping on Physiological Indicators and Comfort
Newborn Infant, Newborn Health

All Delay Cord Clamping trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2011. 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? a Pilot Study
ClinicalTrials.gov ID: NCT01497340
Acronym / sponsor ID: funda03
Conditions: Delay Cord Clamping, Placental Trasfusion
Keywords: Cord clamping, newborn, Placental trasfusion, Delivery room
Study type: Interventional
Recruitment status: TerminatedReason stopped: difficulties with the center
Enrolment: 27 participants (actual)
Lead sponsor: Fundacion para la Salud Materno InfantilUniversity, hospital or other
Study start: Oct 2010
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (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.

Detailed description

Pilot study. Randomized controlled trial not blind, in one center. Informed consent will be obtained during pregnancy or admittance and previous to birth.

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.

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 obteined after clamping.

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	Other: 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 with a plastic clamp placed at 1 cm from its cutaneous insertion.
position at Maternal Abdomen	Experimental	Other: Position at Maternal AbdomenThe newborn will be placed on the abdomen and of the mother immediately after the first weight 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 (2 listed)

Term newborns, vigorous born by vaginal delivery, cephalic or vertex presentation.
Signed informed consent.

Key exclusion criteria (9 listed)

History of Placenta previa,
postpartum hemorrhage background, hemorrhage before 20- week- gestation.
Multiple gestation. Background of IUGR prenatally diagnosed. Major congenital malformations diagnosed previous to delivery.
Maternal diseases such as: eclampsia, Rh incompatibility, congestive cardiac failure.
Extraction of blood sample for bank of umbilical cord stem cells.

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: Weight at 10 + 2 sec then Held the baby at the level of introitus and Cord clamping will be performed at 120 sec Weight after clamping	Other	Position at introitus level
Position at Maternal AbdomenNewborns weight's difference between having them weighed immediately after birth and when cord is clamped in both positions(introitus and abdomen).	Other	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 peripherical hematocrit and bilirubin values between the 2 groups .
Time frame: 36-48 hs

Results and safety

The study was stopped early (reason given: difficulties with the center). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2011.
Background: 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.
Background: 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.
Background: 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.
Background: 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.
Background: 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.
Background: 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.
Background: 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.
Background: 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.
Background: 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.
Background: 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.
Background: PubMed 12725547Bystrova K, Widstrom AM, Matthiesen AS, Ransjo-Arvidson AB, Welles-Nystrom B, Wassberg C, Vorontsov I, Uvnas-Moberg K. Skin-to-skin contact may reduce negative consequences of "the stress of being born": a study on temperature in newborn infants, subjected to different ward routines in St. Petersburg. Acta Paediatr. 2003;92(3):320-6. doi: 10.1080/08035250310009248.
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.

Related trials for Delay Cord Clamping

Active, not recruiting
Prone Positioning During Delayed Cord Clamping
Delayed Cord Clamping
Active, not recruiting
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
IVH- Intraventricular Hemorrhage, Extreme Prematurity
Not yet recruiting
30-Second Versus Pulsation-Based Delayed Cord Clamping in Term Newborns
Umbilical Cord Clamping
Recruiting
Cord Clamping Among Neonates With Congenital Heart Disease
Congenital Heart Disease (CHD)
Enrolling by invitation
The Effect of Different Positions Given to the Newborn During Delayed Cord Clamping on Physiological Indicators and Comfort
Newborn Infant, Newborn Health

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.

Jorge Tavosnanska, MD principal investigator

HOSPITAL GENERAL DE AGUDOS JUAN A. FERNANDEZ

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 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: stopped early, as of the sponsor's last update on 22 Dec 2011. 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.

Are results available for this study?

The study was stopped early (reason given: difficulties with the center). 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?

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 NCT01497340, which also lists 14 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 22 Dec 2011.