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. 2019 Sep 17;2019(9):CD003248. doi: 10.1002/14651858.CD003248.pub4

Rabe 2011.

Methods Randomised controlled trial
Participants Inclusion criteria
  • Preterm neonates between 24+0/7 and 32+6/7 completed weeks of gestation

  • N = 58 babies


Exclusion criteria
  • Multiple pregnancies (twins and more), fetal hydrops, Rhesus sensitisation, or known major congenital abnormalities

Interventions Intervention: DCC
  • Cord clamped at 30 secs

  • Babies were positioned 20 cm below the level of the placenta, between their mother’s thighs (vaginal birth) or to the mother’s side (caesarean).

  • The neonates in both groups were placed immediately in plastic bags to maintain their temperature. The 30 secs of cord clamping time was measured by using the wall‐mounted clocks in each delivery suite.

  • Women received a combination of oxytocin and ergometrine by intramuscular injection (unless the mother had hypertension, in which case oxytocin alone was administered) and, after caesarean intravenous oxytocin was administered.

  • N = 31 babies


Comparator: UCM
  • Cord milking involved holding the cord at the introitus or caesarean wound with 1 hand and milking the umbilical cord for its remaining accessible whole length toward the neonate 4 times. The cord was clamped after the 4th milking.

  • Neonates were positioned 20 cm below the level of the placenta, between the mother’s thighs (vaginal birth) or to the mother’s side (caesarean), with the cord being milked toward the neonate 4 times at a speed of 20 cm/2 secs. ·

  • The neonates in both groups were placed immediately in plastic bags to maintain their temperature. The 30 secs of cord clamping time was measured by using the wall‐mounted clocks in each delivery suite.

  • Women received a combination of oxytocin and ergometrine by intramuscular injection (unless the mother had hypertension, in which case oxytocin alone was administered) and, after caesarean birth intravenous oxytocin was administered.

  • N = 27 babies


Additional information
  • Gestational subgroup: < 32‐34 weeks' gestation

  • Resuscitation with cord intact: not available

  • Access to NICU: yes

  • Length of delay: 30 secs

  • Baby placed: low

  • Uterotonic: after cord clamping

  • UCM: 4 times with cord intact


Comparison 5
DCC with neonatal resuscitation after cord clamping vs UCM (subgroup by gestation)
Subgroup 1: < 32‐34 weeks' gestation
Comparison 6
DCC with neonatal resuscitation after cord clamping vs UCM (subgroup by type of intervention)
Subgroup 2: DCC at < 1 min with baby low (+ gravity)
Outcomes Primary
  • Neonatal blood Hct and Hb at 1 hour after birth.


Secondary
  • Cord blood pH; Apgar scores at 5 and 10 mins; temperature on admission to the neonatal unit; blood pressure at 4 hrs of age; blood sugar on admission; maximum serum bilirubin and duration of phototherapy; Hct and Hb at 24 hrs, day 3, day 7, and weekly thereafter; number of blood transfusions in first 42 days of life; IVH (staging according to Papile); number of septic episodes in first 42 days of life; death of newborn or mother; days requiring ventilation; number of surfactant treatments; days requiring oxygen; bronchopulmonary dysplasia defined as oxygen requirement at 36 weeks of corrected age; RoP; NEC (staging according to Bell); length of hospital stay.

Notes Setting: single tertiary care centre ‐ Royal Sussex County Hospital, Brighton, UK
Dates: 2007 to 2009
Declaration of interest: authors reported no potential conflicts of interest.
Trial funding source: quote: “Funded by a grant from the Brighton and Sussex University Hospitals Research and Development Directorate.” Also partly funded by National Institute of Health Research under Research for Patient Benefit Programme (PB‐PG‐1208‐18244).
Further information
  • In the follow‐up study in 2016, authors also reported on the Bayley‐III scores for cognitive, language and motor development using Bayleys 111 at 2 and 3.5 years. The paper also reported the scores 70‐84 and > 85 at both 2 years and 3.5 years.

  • H Rabe provided some unpublished data regarding this study. This included data on dates, the Bayley III overall scores and the composite of 'Death and neurosensory disability at 3.5 years' in an email on 29/04/18.

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Randomization was based on computer‐created tables performed by a person not involved in the trial. The randomization was stratified by gestational age, 24 0/7 to 27 6/7 completed weeks of gestation and 28 0/7 to 32 6/7 weeks of gestation”
Allocation concealment (selection bias) Low risk Quote: "The randomization allocation cards were kept on the labor ward in sealed opaque envelopes and consecutively numbered. The attending midwife opened the envelope before birth”
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Unable to blind participants/personnel due to quote: “nature of the interventions” and “routine practice that the neonatal team is directly present in the delivery room”.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Unable to blind data collector to allocation group but data retrospectively collected from patient records so difficult to influence numerical data, e.g. Hb or presence/absence of morbidity.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All randomised babies had data available. All exclusions accounted for. No loss to follow‐up and no failures to deliver intended intervention. Except the long‐term follow‐up where data were missing on 14/31 (45%) in DCC and 5/27 (18%) in UCM. Authors report that some parents did not want to come back for the 3.5. year follow‐up.
Selective reporting (reporting bias) Unclear risk All outcomes appear to be reported but 2 and 3.5 year neurological data reported in a later paper (Rabe 2015) and it was unclear in the original paper that these data were to be collected.
Other bias Unclear risk Baseline data on women and babies were similar. Long‐term follow up ‐ data missing on 14/31 (45%) in DCC and 5/27 (18%) in UCM. Authors report that some parents lost interest at 3.5 years as children were doing well and often families were busy.