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

Tiemersma 2015.

Methods Randomised controlled trial
Participants Inclusion criteria
  • Pregnant women expected to give birth vaginally to a low birthweight infant.

  • We used intrapartum symphysis‐fundal height (SFH) ≤ 32 cm as a predictor for low birthweight (Mohanty et al. 1998; Bothner et al. 2000). As the actual birthweight could only be assessed after delivery, we accepted an error of 500 g (20%) and included newborns up to 3000 g.

  • N = 108 babies but this included all gestations.


Exclusion criteria
  • Women admitted in advanced labour; multiple pregnancies; twin pregnancies; history of PPH; various maternal complications (antepartum blood loss, PIH, pre‐eclampsia and gestational diabetes).

  • Infants initially randomised but subsequently not studied were those who needed resuscitation, those who ended up being delivered by CS, those with major congenital abnormalities, those with a tight nuchal cord and those with a birthweight over 3000 g.

Interventions Intervention: DCC
  • Cord clamped between 120 secs and 180 secs after birth

  • N = 88 babies but this includes all gestations ‐ 26 babies were preterm


Comparator: ECC
  • Cord clamped within 30 secs

  • N = 93 babies but this includes all gestations ‐ 24 babies were preterm


Additional information
  • Gestational subgroup: mixed gestation

  • Resuscitation with cord intact: not available

  • Access to NICU: yes

  • Length of delay: 120‐180 secs

  • Baby placed: mother's abdomen

  • Uterotonic: before cord clamping

  • UCM: n/a


Comparison 1
DCC with neonatal resuscitation after cord clamping vs ECC (subgroup by gestation)
Subgroup 3: mixed gestation
Comparison 2:
DCC with neonatal resuscitation after cord clamping vs ECC (subgroup by type intervention)
Subgroup 5: DCC at > 2 mins with baby level with uterus and placenta
Outcomes Primary
  • Difference between the Hb obtained from the cord blood and the Hb at 2 months.


Secondary
  • Hyperviscosity syndrome

  • Hyperbilirubinaemia on the first day postnatally

  • Infant iron status 2 months later.


Also:
  • mortality, weight; length; head circumference; Hb and changes from baseline; anaemia; MCV; ferritin; transferrin saturation; breastfeeding; formula feeding; mixed feeding; positive HIV PCR result

Notes Setting: Stanger Provincial Hospital in Stanger, KwaZulu‐Natal, South Africa.
Dates: February to October 2012
Declaration of interest: not reported
Trial funding source: quote: “This study was supported by the Otto Kranendonk Fund of the Netherlands Society for Tropical Medicine and International Health and Drager Medical South Africa (Pty) Ltd. The funding organisations did not participate in the study design, collection, analysis and interpretation of data. They had no participation either in the writing of the report or in the decision to submit the manuscript for publication.”
Further information
  • S Tiemersma kindly provided data on the preterm babies (26 randomised to DCC and 24 to ECC) on 11 December 2015. The only data helpful to this review were that on infant mortality.

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Computer generated blocks of 10 participants"
Allocation concealment (selection bias) Low risk Quote: "...sequentially numbered sealed opaque envelopes. Randomisation cards were not reused in case of post‐randomisation exclusion."
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "The nature of the intervention prevented us from blinding the study."
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: "The nature of the intervention prevented us from blinding the study."
Not stated whether assessment postnatally was done by blinded assessors or not. If unblinded, unlikely to have influenced Hb/Hct or non‐subjective measures but may have influenced clinical judgement, e.g. regarding hyperviscosity diagnosis in the intervention. However, no diagnoses were made of this in either group – reduced effect of bias.
Incomplete outcome data (attrition bias) 
 All outcomes High risk 77 out of 181 randomised were excluded (42.5%) because birthweight was > 3 kg. also 7/88 (8%) babies in DCC group excluded because they needed resuscitation and had ECC. None in ECC group were excluded for this.
Selective reporting (reporting bias) Unclear risk Reported data on all primary and secondary objectives mentioned as well as reported non‐significant parameters. However, we have not assessed trial protocol.
Other bias Unclear risk There were no differences between groups with respect to maternal age, maternal nutritional status, HIV‐positivity, Hb, birthweight, gestational age, gender or cord blood values. Not using ITT because they excluded babies in DCC group who got ECC.