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Delayed cord clamping in Rh-isoimmunised infants: an open labelled randomised control trial

Delayed cord clamping in Rh isoimmunised infants

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/12/007592
Enrollment
62
Registered
2016-12-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: null- Rh isoimmunised infants with more that 28weeks 0days gestation to 41weeks days gestation

Interventions

Intervention1: delayed cord clamping: delayed cord clamping for 60 seconds after delivery in Rh isoimmunised infants Control Intervention1: immediate cord clamping: immediate cord clamping in Rh isoim

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Rh isoimmunised infants at time of birth from 28wks 0 days to 41 weeks 6 days willing for follow up till 12weeks postnatal age

Exclusion criteria

Exclusion criteria: 1. Babies with major congenital anomalies 2. Rh isoimmunised babies born to Retro positive mother 3. Babies born with significant antepartum hemorrhage due to causes like abruptio placentae (significant antepartum bleed into placenta after separation of decidua), cord prolapsed ( protrusion of cord along with or ahead of delivery of baby) and cord anomalies like true knot all of which are associated with significant peripartum asphyxia and need immediate resuscitation

Design outcomes

Primary

MeasureTime frame
To measure Packed cell volume within 2(±1)hr of birth, in Rh isoimmunised infants randomised to early cord clamping group or late cord clamping group, with gestation age more than 28weeks and 0 days to 41weeks and 6 daysTimepoint: To measure Packed cell volume within 2(±1)hr of birth, in Rh isoimmunised infants randomised to early cord clamping group or late cord clamping group, with gestation age more than 28weeks and 0 days to 41weeks and 6 days

Secondary

MeasureTime frame
Echocardiographic evidence of fluid overload and hemodynamic compromiseTimepoint: once at 8-16hours of age(mean at 12hours.;Incidence of blood transfusion in initial 12weeks (±2) weeksof age inRh isoimmunised infantsTimepoint: Blood transfusion done as per unit protocol cutoffs).After discharge will be assessed at wk,6wk, 10 week of age with variation of 2 wks at each visit;Number of babies undergoing double volume exchange transfusion( DVET)Timepoint: at time of discharge;Number of babies undergoing partial exchange transfusion (PET)Timepoint: at birth, using as per unit protocol;Total duration of phototherapy(PT)Timepoint: At time of discharge

Countries

India

Contacts

Public ContactDr Ashok Deorari

AIIMS,New Delhi

ashokdeorari_56@hotmail.com01126593619

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026