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AzTrials

AnemiaPhase 2NCT01081977

Effect of Timing of Umbilical Cord Clamping on Haematological and Clinical Outcomes of Infants

A Phase 2 study testing Early Cord Clamping and Delayed Cord Clamping in people with Anemia and Ferritin, run by Aga Khan University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In developing countries up to 50% of children become anemic by 12 months of age(1. Iron deficiency anemia is a major risk factor for neonatal and infantile mortality and morbidity in Pakistan. It has detrimental effects on neurodevelopment of infants and may be irreversible even after iron therapy(2). Read more about this study

Who is it for?
Ages 1 minute to 3 monthsHealthy volunteers can take part
Conditions the study is for
Anemia, Ferritin, Complications
What is being tested?
Early Cord Clamping and Delayed Cord Clamping
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
340 participants
Where
1 sitePakistan
Study dates
Aug 2008to Apr 2010
Phase
Phase 2
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 1 minute to 3 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Mother-infant pairs, between 35 weeks and 41 completed weeks of pregnancy, planned to deliver through vaginal or Elective lower segment cesarean section(ELSCS)

Who cannot join

  • Women with multiple gestation
  • Complications like pregnancy induced hypertension (PIH), Gestational diabetes Mellitus (GDM), Pre/Eclampsia, placental insufficiency, suboptimal CTG (late deceleration, variable deceleration)
  • Rh-isoimmunization
  • Chronic maternal illnesses (hypertension, cardiomyopathies, chronic renal diseases, haemoglobinopathies
  • Pre-existing risk factor for postpartum haemorrhage, like polyhydramnios, previous PPH
  • Infants with antenatal diagnosis of congenital malformations of any system (CVS, GIT, RENAL CNS ,RESP), anomalies or syndromes
Show all 9Show fewer
  • Emergency caesarean section (EmLSCS)
  • Need for neonatal resuscitation at birth and NICU admission due to causes not directly related to the intervention trial.
  • Criteria 1 to 6 will be applied before randomization and criteria 7 and 8 assess after randomization.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • The Aga Khan University Hospital

    Karachi, Sindh, 75300

Other trials in Pakistan

About this study

Official title: Effect of Timing of Umbilical Cord Clamping on Haematological and Clinical Outcomes of Infants at Birth and Three Months of Age

In developing countries up to 50% of children become anemic by 12 months of age(1. Iron deficiency anemia is a major risk factor for neonatal and infantile mortality and morbidity in Pakistan. It has detrimental effects on neurodevelopment of infants and may be irreversible even after iron therapy(2). Type of cost effective interventions during perinatal period for prevention of anemia in later infancy is limited. Delayed cord clamping has a beneficial effect on prevention of anemia in later infancy because of increased iron stores at birth(3. However there are controversies in incorporating delayed cord clamping practice in the management of third stage of labour globally(4) Paucity of national guidelines and lack of substantial data in Pakistan on this topic strongly necessitates such study trials. This study may contribute to develop a protocol on the timing of cord clamping which will be cost effective in prevention of iron deficiency anemia in the investigators infantile population.

The investigators will conduct a randomized controlled trial and the investigators hypothesis is that delayed cord clamping will result in higher hemoglobin (Hb), hematocrit (Hct) and ferritin at third month as compared to early cord clamping.

Read more

OBJECTIVES:

A- Primary:

  1. To study the effect of timing of umbilical cord clamping on hemoglobin (Hb), Hematocrit (Hct) at birth, 48 hours and Hb, Hct and ferritin at three months of age.
  2. To study the effect of timing of umbilical cord clamping on short term clinical profile of neonates like jaundice, respiratory distress, anemia, polycythemia etc. during fist 24 to 48 hours of life.

B- Secondary:

To assess whether delayed cord clamping is associated with undesirable effects on mothers followed till 48 hours postpartum.

Read the detailed description

Delayed umbilical cord clamping (DCC) results in approximately 30-40 ml additional placental blood volume transfusion to the neonate and 30-35 mg increase in iron stores at birth(5).The neonatal benefits include higher hematocrit (Hct), higher red blood cells flow to vital organs, better cardiopulmonary adaptation, additional iron stores and less anemia in later infancy(6).It is evident from different studies that no adverse effects of DCC have been noticed in mothers as well as in their neonates(7). The beneficial effect of delayed cord clamping is not only observed in term infants but it has a positive impact on preterm and small for gestational age (SGA) infants too. The requirement of packed cell transfusion in first six months has significantly reduced as noticed from different studies(8).It is also associated with lower risk of intraventricular hemorrhage and late onset sepsis in preterm infants(9).

The practice of early cord clamping (ECC) is commonly following in our maternity units. It is believed that it reduces the risk of post partum haemorrhage (PPH) and duration of third stage of labour. But at the same time it does not provide any benefit to the neonate(4).Conversely it increases the possibility of fetomaternal transfusion, hypovolemic damage, neonatal anemia, respiratory distress syndrome and type 2 diabetes in later life(5).The risk of iso immunization in rhesus negative mothers are also increased with ECC(10).

Being tested
Early Cord Clamping, Delayed Cord Clamping
Keywords
Delayed cord clamping, Ferritin, Hemoglobin, Neonatal anemia, Postpartum haemorrhage, Neonatal jaundice
Medical subject headings
Anemia, Hemorrhage, Jaundice, Anemia, Neonatal, Postpartum Hemorrhage, Jaundice, Neonatal

What participants receive

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

  • Early Cord ClampingProcedure or surgery

    Also called Cord clamping, Neonate, Anemia

    Early Umbilical Cord Clamping (Clamping of Umbilical Cord within 30 seconds of shoulder delivery of neonate)

  • Delayed Cord ClampingProcedure or surgery

    Also called Cord clamping, Ferritin, Infant

    Delayed Umbilical Cord Clamping (Clamping Umbilical Cord after 2 minutes of shoulder delivery of neonate

Study groups in NCT01081977
Study groupRoleWhat they receive
Early Cord Clamping GroupActive comparatorEarly Cord Clamping Group (Clamping of Umbilical Cord within 30 seconds of shoulder delivery of neonate).
Receives: Procedure: Early Cord Clamping
Delayed Cord Clapming GroupExperimentalDelayed Umbilical Cord Clamping Group (Clamping of Umbilical Cord within 2 minutes of shoulder delivery of neonate).
Receives: Procedure: Delayed Cord Clamping

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hematological Characteristics of Infants

    Infantile hematological characteristics ( hemoglobin, hematocrit at birth(cord),48 hours of age and Hemoglobin, Hematocrit and serum ferritin at third month).

    Measured: From Birth to Third month of age

  2. Short term Clinical Profiles

    Short term neonatal clinical profile (respiratory distress, polycythemia hematocrit ≥65%), neonatal anemia , clinical jaundice hyperbilirubinemia),requirement of phototherapy or exchange transfusion)

    Measured: From birth to 48 hours of age

Secondary outcomes (1)

  1. Maternal Characteristics

    Maternal characteristics ( Primary PPH, duration of third stage of labour ≥ 30 min, mean blood loss during the third stage of labour, need for therapeutic oxytocin, manual removal of placenta and Hb at 48 hours postpartum).

    Measured: From Delivery to 48 hours postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2010 (estimated)
  2. Study startAug 2008
  3. Primary completionMar 2010
  4. Study completionApr 2010

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
340 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01081977
Sponsor's protocol ID
991-Ped/ERC-08
Status last verified
Aug 2012
First submitted
4 Mar 2010
Last updated
2 Aug 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 1. World Health Organozation. Newborns: No longer going unnoticed. The World Health Report:2005.p 79-101. . 2005 [updated 2005; cited]; Available from: http://www.who.int/whr/2005/en/. 2. Shafir T, Angulo-Barroso R, Jing Y, Angelilli ML, Jacobson SW, Lozoff B. Iron deficiency and infant motor development. Early Hum Dev. 2008 Jul;84(7):479-85. 3. 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. 4. Ononeze AB, Hutchon DJ. Attitude of obstetricians towards delayed cord clamping: a questionnaire-based study. J Obstet Gynaecol. 2009 Apr;29(3):223-4. 5. Bhutta ZA, Ahmed T, Black RE, Cousens S, Dewey K, Giugliani E, et al. What works? Interventions for maternal and child undernutrition and survival. Lancet. 2008 Feb 2;371(9610):417-40. 6. Zaramella P, Freato F, Quaresima V, Secchieri S, Milan A, Grisafi D, et al. Early versus late cord clamping: effects on peripheral blood flow and cardiac function in term infants. Early Hum Dev. 2008 Mar;84(3):195-200. 7. McDonald SJ, Middleton P. Effect of timing of umbilical cord clamping of term infants on maternal and neonatal outcomes. Cochrane Database Syst Rev. 2008(2):CD004074. 8. Strauss RG, Mock DM, Johnson KJ, Cress GA, Burmeister LF, Zimmerman MB, et al. A randomized clinical trial comparing immediate versus delayed clamping of the umbilical cord in preterm infants: short-term clinical and laboratory endpoints. Transfusion. 2008 Apr;48(4):658-65. 9. Mercer JS, Vohr BR, McGrath MM, Padbury JF, Wallach M, Oh W. Delayed cord clamping in very preterm infants reduces the incidence of intraventricular hemorrhage and late-onset sepsis: a randomized, controlled trial. Pediatrics. 2006 Apr;117(4):1235-42. 10. Levy T, Blickstein I. Timing of cord clamping revisited. J Perinat Med. 2006;34(4):293-7.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Early Cord Clamping and Delayed Cord Clamping in people with Anemia and Ferritin, run by Aga Khan University at 1 site in Pakistan.

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 1 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 2 Aug 2012. 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 Pakistan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 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?

Hematological Characteristics of Infants (time frame: From Birth to Third month of age). The study lists 2 primary outcomes in all. 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 NCT01081977, 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 2 Aug 2012.

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