Methods |
Randomised controlled trial |
Participants |
Inclusion criteria
Exclusion criteria
Pregnant women carrying fetuses with known major fetal structural or chromosomal abnormalities, multiple gestations, diabetes, IUGR, or non reassuring fetal heart tracings.
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Interventions |
Intervention: UCM
3‐4 passes of milking of the umbilical cord toward the neonate
Cord clamped after 30 secs
Oxytocin after placental delivery
Care also included warming mattress, bulb suction and stimulation as appropriate
N = 99 babies
Comparator: ECC
Additional information
Gestational subgroup: < 32‐34 weeks' gestation
Resuscitation with cord intact: not available
Access to NICU: yes
Length of delay: UCM + delay 30 secs
Baby placed: no information so assume level with uterus or placenta
Uterotonic: after cord clamping (actually after birth)
UCM: 3‐4 times with DCC
Comparison 7 UCM vs ECC (subgroup by gestation) Subgroup 1: < 32‐34 weeks' gestation Comparison 8 UCM vs ECC (subgroup by type of intervention) Subgroup 1: cord intact during UCM |
Outcomes |
Primary
Secondary
Initial Hb and Hct (Hct and Hb were determined on venous blood drawn within the first 4 hrs of life)
IVH. Each preterm neonate had transfontanellar cranial ultrasound scans within the first 3 days of life and on day 7. Neurosonograms were evaluated by skilled radiologists not aware of the assigned group with regard to cord clamping. IVH was graded as described by Papile et al.8
Periventricular leukomalacia was diagnosed by the presence of persistent echogenicity or echolucent areas in the periventricular region on sagittal and coronal views
Requirement for resuscitation
Apgar scores at 5 mins and 10 mins
Hypothermia during first hour of life
Death
RDS (assessed by clinical signs, oxygen requirement, respiratory support, chest radiograph) during first 36 hrs of life.
Use of exogenous surfactant.
Days of ventilation.
Days of oxygen dependency.
Oxygen dependency at 28 days after birth.
Oxygen dependency at equivalent of 36 completed weeks of gestational age.
Chronic lung disease (Northway stage 2, 3, or 4).
Number and volume of blood transfusions
Volume (colloid, sodium chloride 0.9%, blood transfusion) administration for hypotension during the first 24 hrs of life, inotropic support for hypotension during the first 24 hrs of life, and
Treatment for PDA
Rate of anaemia of prematurity (defined as Hb less than 10 g/dL or Hct less than 30%)
Treatment for hyperbilirubinaemia with phototherapy
Treatment for hyperbilirubinaemia with blood exchange transfusion
IVH grades 3 and 4
Periventricular leukomalacia
NEC
Maternal outcome evaluated included postpartum haemorrhage, retained placenta, uterine inversion, and maternal mortality
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Notes |
Setting: Teaching and Research Center of Konya, University of Baskent, Turkey. Dates: September 2008 – April 2009 Declaration of interest: the authors reported no potential conflicts of interest. Trial funding source: sponsor was University of Oklahoma Further information:
Dr A Elimian kindly provided additional information (24.02.2016) regarding this study. In particular, the babies in the intervention group received UCM before the cord was clamped and cut at after 30 secs. We have chosen to regard the intervention, therefore, as UCM.
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Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Quote: “Allocation sequence was generated by a computer"
|
Allocation concealment (selection bias) |
Low risk |
Quote: “The allocation sequence was concealed by using sequentially numbered, opaque, sealed envelopes kept in a central location on labor and delivery.” |
Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Open label |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
The only blinding was the neuroradiologists who interpreted the cranial ultrasound scans so IVH and PVL are low risk of bias. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No losses after randomisation. |
Selective reporting (reporting bias) |
Unclear risk |
We checked the publication against the trial registration form, but the form did not list the outcomes to be measured. Requirement for resuscitation was the only unreported outcome. Some outcomes reported in categorical way when continuous data were suggested in methods and could easily have been given. |
Other bias |
Low risk |
Used ITT. No difference at baseline for maternal age, height and weight, ethnicity, and selected maternal outcome variables. No other biases apparent. |