Original article

Arch Dis Child Fetal Neonatal Ed: first published as 10.1136/archdischild-2018-316649 on 9 May 2019. Downloaded from http://fn.bmj.com/ on February 3, 2020 at Swets Subscription
Postpartum use of oxytocin and volume of placental
transfusion: a randomised controlled trial
Nestor E Vain,1,2 Daniela S Satragno,2,3 Juan Esteban Gordillo,4 Ariel L Fernandez,2
Guillermo Carrolli,5 Norma P Romero,4 Luis M Prudent2

1
Pediatrics, Hospital Trinidad,
University of Buenos Aires,
Buenos Aires, Argentina
2
Fundasamin, Buenos Aires,
Argentina
3
Neonatology, Hospital de Ninos
Ricardo Gutierrez, Buenos Aires,
Argentina
4 vaginal delivery with informed consent provided in early
Neonatology, Instituto de
Maternidad y Ginecología
Nuestra Señora de Las
Mercedes, Tucumán, Argentina
5
Centro Rosarino de Estudios
Perinatales, Rosario, Argentina
Correspondence to
Abstract
Objective  To assess whether oxytocin administered What is already known on this topic?
before clamping the umbilical cord modifies the volume
►► Delaying umbilical cord clamping (DCC) for
of placental transfusion.
at least 1 min results in the passage of blood
Design  Randomised controlled trial.
from the placenta to the infant (placental
Methods  Mothers of term infants born vigorous by
transfusion).
►► DCC is currently recommended in term infants
labour were randomly assigned to oxytocin (10 IU) given
to decrease iron deficiency, and in preterm
intravenously within 15 s of birth (group 1) or after
births to improve cardiorespiratory transition
clamping the umbilical cord 3 min after delivery (group
and increase blood volume.
2). Soon after birth, all infants were weighed using a 1 g
►► Oxytocin is routinely administered to mothers
precision scale and subsequently placed on the mother’s
soon after birth to prevent postpartum
abdomen or chest. At 3 min, in both groups, the cord was
haemorrhage, but its influence on the volume of

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Dr Nestor E Vain, Pediatrics,
Hospital Trinidad, University
of Buenos Aires, Buenos Aires
1426, Argentina;
​nestorvain@​gmail.c​ om
Received 4 December 2018
Revised 21 March 2019
Accepted 25 March 2019
Published Online First
9 May 2019
© Author(s) (or their
employer(s)) 2020. No
commercial re-­use. See rights
and permissions. Published
by BMJ.
To cite: Vain NE, Satragno
DS, Gordillo JE, et al. Arch Dis
Child Fetal Neonatal Ed
2020;105:F14–F17.
F14   Vain NE, et al. Arch Dis Child Fetal Neonatal Ed 2020;105:F14–F17. doi:10.1136/archdischild-2018-316649
clamped and cut, and the weight was again obtained.
The primary outcome (volume of placental transfusion)
was estimated by the difference in weights.
Results  144 patients were included. There were no
differences in the primary outcome: infants in group
1 (n=70) gained a mean weight of 85.9 g (SD 48.3),
and in group 2 (n=74) 86.7 g (SD 49.6) (p=0.92). No
differences were found in secondary outcomes, including
newborns’ haematocrit and bilirubin concentrations
and severe maternal postpartum haemorrhage. On the
advice of the Data and Safety Monitoring Committee, the
trial was stopped due to futility at 25% of the planned
sample size.
Conclusions  When umbilical cord clamping is delayed
for 3 min, term newborn infants born vigorous receive
a clinically significant placental transfusion which is not
modified by the administration of intravenous oxytocin
immediately after birth.
Trial registration number  NCT02618499.
The optimal timing for umbilical cord clamping
(UCC) has been controversial. After delivery of the
infant and before the cord is clamped, passage of
blood from the placenta to the infant takes place;
this is known as placental transfusion (PT). Blood
returning from the placenta towards the infant
through the umbilical veins, and from the infant
to the placenta through the umbilical arteries,
continues for several minutes.1 A number of factors
influence the volume of PT, including timing of
UCC, onset of breathing, crying, uterine contrac-
tions and other less investigated factors.1–3 Gravity
has been considered another factor.4 However,
we demonstrated in a randomised controlled trial
(RCT) that gravity has no influence: in infants
with UCC at 2 min, there was no difference in the
volume of PT comparing a group held on the moth-
er’s abdomen or chest with others held at the level
of the vagina.5
placental transfusion is unknown.
What this study adds?
►► Routine administration of oxytocin to mothers
immediately after birth, before delayed
clamping of the umbilical cord, does not
influence the volume of placental transfusion.
►► To administer oxytocin after clamping, the
umbilical cord would not modify the positive
effects of delaying umbilical cord clamping on
term infants.
Because of the increase in haemoglobin levels,
iron stores and other potential benefits, delayed
UCC is currently recommended by the Interna-
tional Liaison Committee on Resuscitation and
other professional associations.6–8
To decrease the risk of maternal postpartum
haemorrhage, administration of oxytocin to
the mother soon after birth is currently recom-
mended.9 10 A study from 1968 suggested that
administration of another uterotonic, methylergo-
metrine, increases the passage of blood to the infant
during the first minute of life.11 It is important to
know whether postpartum oxytocin administered
before the umbilical cord is clamped, a sequence of
events occurring in a large number of deliveries all
over the world, influences the volume of PT. To our
knowledge no clinical studies evaluating its effects
have been previously published. We aimed to assess
whether administration of intravenous oxytocin
immediately after birth modifies the volume of PT
in infants whose umbilical cord was clamped at
3 min.

Methods
Study design and participants
This is a single-­ centre RCT conducted at a large maternity
hospital in Argentina (Instituto de Maternidad y Ginecología
Nuestra Señora de Las Mercedes, Tucumán) to test the hypoth-
esis that oxytocin given to mothers at birth increases the volume
of PT. Mothers were approached and gave written consent on
admittance to hospital for labour (mothers in advanced labour
were not approached because of insufficient time to obtain
an ethically valid informed consent). Women with a term
normal pregnancy in whom a vaginal uncomplicated delivery
was expected were eligible. Exclusion criteria were history of
placenta previa or postpartum haemorrhage, multiple gesta-
tion, intrauterine growth restriction, congenital malforma-
tions, maternal diseases and request by parents for cord blood
banking. Vigorous newborn babies born by vaginal delivery in
cephalic presentation were included in the analysis. According
to pre-­ established elimination criteria, infants delivered by
caesarean section or forceps, born with a short umbilical cord or
a tight nuchal cord, or needing resuscitation, although initially
randomised, were not considered in the analysis.
Randomisation and masking
Eligible newborns were randomly assigned in a 1:1 ratio to
group 1 (immediate oxytocin) or group 2 (oxytocin at 3 min)
using computer-­generated allocation sequence in block sizes
of four to eight. Allocation was concealed by sequentially
numbered, sealed, opaque envelopes.
Procedures
After obtaining informed parental consent, we randomly
assigned newborns to the immediate or 3 min oxytocin group,
and the obstetric team was notified. All infants were weighed
immediately after birth at the level of the vagina using an elec-
tronic 1 g precision scale (STW-6 BB Electronic, Balanzas CAM,
Argentina; coefficient of variation of 0.0006 g). A reliable weight
is usually obtained within the first 15 s. A towel with a known
dry weight was kept in advance on the weight scale. The infant
was wrapped with the towel during the process to prevent even-
tual loss of urine outside the weight scale. Time 0 was delivery of
the shoulders. Using a stopwatch (SH-688 STAR, Fuego, China),
a nurse notified the team at 15 s and 180 s. Ten international
units of oxytocin were administered intravenously to mothers
assigned to group 1 within the first 15 s after birth, and after
clamping the umbilical cord at 3 min to those assigned to group
2. All infants were placed after birth on the mother’s abdomen;
care was taken to avoid compression of the umbilical vessels.
At 3 min, the cord was clamped and cut in the babies of both
groups, and they were weighed again on the same scale.
Apgar scores and time to initial weight were recorded. Venous
haematocrit and bilirubin values were obtained at 36–48 hours
simultaneously with routine neonatal screening.
Outcomes
We used the increment in birth weight as a proxy for volume of
PT as it has been previously reported.5 12–14 The primary outcome
was the difference between the infant’s weight obtained immedi-
ately after birth and the one registered at 3 min.
The secondary outcomes were haematocrit and bilirubin
concentrations, incidence of polycythaemia, need for photo-
therapy and severe maternal postpartum haemorrhage, defined
by the need for blood transfusion or the use of any treatment for
haemodynamic instability.
Vain NE, et al. Arch Dis Child Fetal Neonatal Ed 2020;105:F14–F17. doi:10.1136/archdischild-2018-316649
Original article
Arch Dis Child Fetal Neonatal Ed: first published as 10.1136/archdischild-2018-316649 on 9 May 2019. Downloaded from http://fn.bmj.com/ on February 3, 2020 at Swets Subscription
Figure 1  Flow chart.
Statistical analysis
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Based on our previous study using a similar model, for sample
size calculation, we assumed a weight difference of 55±46 g
(SD).5 A sample size of 275 infants per group was estimated to
detect a 20% difference in the increment in birth weight (two
tails), with 80% power and significance level of 5%.
We used t-­test, Mann-­Whitney U test and χ² test for group
comparison, and multivariable linear regression analysis to
adjust for confounding factors (Stata IC V.11).
An external Data and Safety Monitoring Committee (DSMC)
composed of three experienced investigators (a paediatrician,
a neonatologist and an obstetrician) who had no relationship
with the participating hospital was notified of any adverse event
throughout the study. A previously planned interim analysis was
performed after inclusion of the first 144 patients (25% of the
estimated population of the study) to ensure safety and to assess
the need for a re-­estimation of the sample size.
Results
Between May and November 2016, 171 newborns fulfilled
the inclusion criteria and 5 mothers refused consent. After
informed consent was obtained, some infants could not be
studied: 14 were delivered by caesarean section or forceps, 9
had a short umbilical cord or a tight nuchal cord, 3 needed resus-
citation, and in 1 case the investigator was not available. One
hundred and forty-­ four infants were analysed: 70 assigned
to immediate oxytocin and 74 to the 3 min oxytocin group
(figure 1). We recorded no serious adverse events. Following the
predetermined analysis of these 144 infants, the DSMC recom-
mended to stop recruitment due to futility after a predetermined
recalculation of the sample size based on the available data
resulted in an excessively large trial.
Table 1 presents the characteristics of the mothers and
newborn babies. Both groups were comparable with regard to
demographics and other clinical characteristics. We found a
difference in gender and time to first breath between the groups,
as shown in table 1. The linear regression model that considered
these covariates as possible confounding factors of the associa-
tion between the difference in PT and the  group was −1.95 g
(95% CI −19.13 to 15.22) (p=0.822).
F15
 Original article

Arch Dis Child Fetal Neonatal Ed: first published as 10.1136/archdischild-2018-316649 on 9 May 2019. Downloaded from http://fn.bmj.com/ on February 3, 2020 at Swets Subscription
Table 1  Characteristics of mothers and newborn babies
Group 1 Group 2
Oxytocin 15 s (n=70) 3 min (n=74)
Maternal age, years, mean±SD 25±6.8 24.2±6.2
First pregnancy, n (%) 27 (38) 26 (35)
Apgar score, median (IQR)
1 min* 8 (8–8) 8 (8–8)
5 min 9 (9–9) 9 (9–9)
Gestational age (weeks), mean±SD 39.1±0.9 39.1±0.9
Birth weight (g), mean±SD 3309±424 3218±377
Gender, female, n (%)‡ 26 (37) 44 (59)
Time to first breath (s), mean (SD)§ 9.5 (10) 6.2 (5.6)
Admitted to the NICU, n (%) 3 (4.2) 2 (2.7)
*P=0.2480.
†P=0.2497.
‡P=0.007.
Figure 2  Initial and 3 min weight in group 1 and group 2.
§P=0.016.
NICU, neonatal intensive care unit.
found that in infants whose mothers received oxytocin during
the first 15 s after birth, the volume of PT estimated by the
Table 2 and figure 2 show the data on the primary outcome. The weight gain was 85.9±48.3 g, almost identical to the weight
average weight gain for newborn babies in the immediate oxytocin gain in the group receiving oxytocin at 3 min after clamping the
group was 85.9 g (SD 48.3), and 86.7 g (SD 49.6) in the 3 min

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umbilical cord (86.7±49.6 g).
oxytocin group (after clamping the umbilical cord). This could also The difference in PT between the two groups adjusted for
be expressed as 26.2 g/kg (SD 15.4 g/kg) in group 1 and 27 g/kg (SD gender and time to first breath was on average −1.95 g. Based
15.4 g/kg) in group 2. The weight increase represents 2.62% of on the 95% CI, the difference can vary between an increase of
the body weight in group 1 and 2.7% in group 2. 15.2 g or a decrease of 19 g. This difference was considered of no
There were no differences in venous bilirubin and haematocrit clinical relevance. The DSMC recommended stopping the trial
concentrations obtained at 36–48 hours (table 3). Four infants in due to futility. They considered that the study demonstrated no
group 1 and five in group 2 had haematocrit ≥65%. In none of effect of oxytocin on the volume of PT.
the groups we observed cases of symptomatic polycythaemia or In 1968, a study by Yao et al11 suggested that administration
severe maternal postpartum haemorrhage. of methylergometrine, a different uterotonic in use at that time,
increased the speed but not the final volume of PT in infants
Discussion whose umbilical cords were clamped at 3 min. The authors
Delayed cord clamping is recommended by leading professional postulated that after birth the contraction of the uterus gener-
organisations.6 15 Its use in term births contributes to decreased ated by methylergometrine squeezes the placenta, creating a
iron deficiency in infants and children, a frequent public health pressure gradient between the placenta and the baby, affecting
problem in low-­income countries,16 17 but also common in devel- the initial phase of PT. Our study was not designed to evaluate
oped regions such as North America and Western Europe.18 Up this sequence of events; we did not routinely record uterine
to 20% of preschool children in the USA have depleted iron contractions after the delivery of the infant and before clamping
stores and up to 8% have iron deficiency anaemia.19 of the umbilical cord. Our results confirm that the administra-
Oxytocin is routinely administered to mothers soon after birth tion of a uterotonic does not influence the total volume of PT.
to decrease the risk of postpartum haemorrhage.10 However, A recent study performed in sheep by Polglase et al20 evalu-
optimal timing for its administration (before or after clamping ated the effects of intravenous oxytocin given to the ewe at birth
the umbilical cord) is unknown since the potential impact of on fetuses instrumented in utero and delivered by caesarean
oxytocin on the volume of PT had not previously been investi- section. They found that the contractions produce a significant
gated in clinical studies. decrease in placental blood flow by reducing flow through the
Our RCT demonstrated that 10 IU of intravenous oxytocin umbilical arteries and subsequently blood return through the
administered to mothers immediately after birth does not umbilical veins. As a consequence, there was a decrease in fetal
modify the volume of PT in term infants born vigorous by
vaginal delivery and in whom clamping of the cord was delayed
for 3 min. Table 3  Secondary outcomes
The predetermined evaluation by the DSMC performed on Secondary outcomes Group 1 (n=70) Group 2 (n=74) P value
recruitment of 144 infants (25% of the estimated sample size)
Total bilirubin (mg/dL), 10.7±4.3 10.3±4.15 0.59
mean±SD*
95% CI 9.6 to 11.8 9.3 to 11.4
Table 2  Primary outcome Mean difference −0.4 (−1.1 to 1.9)
Group 1 Group 2 Haematocrit (%), mean±SD* 56.8± 5.9 57.3±4.5 0.64
Weight change (g) 15 s (n=70) 3 min (n=74) P value
95% CI 55.4 to 58.3 56.2 to 58.4
Mean±SD 85.9±48.3 86.7±49.6 0.92 Mean difference −0.4 (−2.3 to 1.4)
95% CI 74.3 to 97.4 75.2 to 98.2 Phototherapy, n (%) 2 (2.8) 2 (2.7) 0.95
Mean difference 0.8g; 95% CI −16.9 to 15.4 (g).
*Values obtained at 36–48 hours.

F16 Vain NE, et al. Arch Dis Child Fetal Neonatal Ed 2020;105:F14–F17. doi:10.1136/archdischild-2018-316649

oxygenation and an increase in cerebral blood flow and heart
rate. They did not quantify the impact of oxytocin on the total
volume of PT. The authors recommended postponing the admin-
istration of oxytocin until the umbilical cord has been clamped.
Although it is unknown if these findings in the sheep model can
be extrapolated to humans born by vaginal delivery or even by
caesarean section, it may be justified to administer oxytocin after
the umbilical cord is clamped. There are no studies demonstrating
any differences in maternal blood loss comparing oxytocin given
intravenously immediately after birth with the administration a
few minutes later. In many cases of natural birth with no intra-
venous in place during labour, oxytocin is given intramuscularly
after the delivery. It is unlikely that oxytocin provided intrave-
nously at 3 min would be less rapid and/or effective than intra-
muscular administration given at birth.10 21 22
Another interesting aspect of our findings is the total volume
of transfusion received by the infants. In the current trial, with
cord clamping at 3 min in both groups, the weight increments
were approximately 86 g, equivalent to 82 cc of blood.23 In a
previous study using a similar model, we showed no difference
in the volume of PT of infants held on the mother’s abdomen
or chest compared with those held at the level of the vagina.5 In
that study, the cord was clamped in all infants at 2 min, and the
weight increments tested with the same methodology and using
the same weight scale were only approximately 55 g. We may
assume that in vigorous infants born by vaginal delivery, PT is
incomplete when the cord is clamped at 2 min. Furthermore, the
increments of weight in the present study are similar to those
reported by Farrar et al and with the results from the most recent
Cochrane review of clinical trials comparing early versus delayed
cord clamping.7 14 Of note, by protocol, all infants in our study
were born by vaginal delivery, and therefore our results may not
apply to infants born by caesarean section.
We did not find any difference in the occurrence of severe
maternal haemorrhage, but the study is underpowered to confirm
this finding. Similarly, we found differences between groups in
gender, most likely related to chance because of the small sample size
due to early stopping of recruitment than to an effect of oxytocin.
The advantages of avoiding early clamping of the umbilical cord
have been clearly demonstrated. Delayed UCC in term newborns
increases haemoglobin levels and iron stores.7 In premature
infants it appears to facilitate cardiovascular stabilisation at birth,
and decrease the need for blood transfusions and the risk of necro-
tising enterocolitis.6 In both preterm and term infants, there is a
slight increase in the development of jaundice.6 7 24 Based on these
findings, delayed UCC is currently recommended for infants born
vigorous.6 8 25 26 In all preterm and term deliveries, oxytocin is indi-
cated soon after birth to decrease the risk of maternal postpartum
haemorrhage. Our study demonstrates that there is no difference
in the volume of PT by giving oxytocin immediately after birth or
after clamping the umbilical cord at 3 min.
Contributors  NV was responsible for the idea of the study, developed the protocol,
organised the study methods, managed and coordinated the study, participated
in data analysis, and wrote the report. DSS developed the protocol, managed and
coordinated the study, trained the staff, participated in data analysis, reviewed the
study methods and data collection procedures, and wrote the report. GC developed
the protocol and reviewed the report. LMP developed the protocol and wrote the
report. ALF participated in the development of the protocol, designed the statistical
methodology, and performed the data analysis and statistical evaluation. JEG and
NPR participated in data management and analysis of the results, and reviewed
the report. All authors approved the final manuscript as submitted and agree to be
accountable for all aspects of the work.
Funding  Perez Companc Foundation and Foundation for Maternal-­Infant Health
(Fundasamin) funded the study. The sponsor of the study had no role in study
Vain NE, et al. Arch Dis Child Fetal Neonatal Ed 2020;105:F14–F17. doi:10.1136/archdischild-2018-316649
Original article
Arch Dis Child Fetal Neonatal Ed: first published as 10.1136/archdischild-2018-316649 on 9 May 2019. Downloaded from http://fn.bmj.com/ on February 3, 2020 at Swets Subscription
design, data collection, data analysis, data interpretation and writing of the report.
The corresponding author had full access to all the data in the study and had final
responsibility for the decision to submit for publication.
Competing interests  None declared.
Patient consent for publication  Not required.
Ethics approval  Protocol and consent were approved by the hospital’s
institutional review board.
Provenance and peer review  Not commissioned; externally peer reviewed.
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