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Uterine Massage to Reduce Blood Loss After

Vaginal Delivery
A Randomized Controlled Trial
Meng Chen, MD, Qing Chang, MD, Tony Duan, MD, Jing He, MD, Li Zhang, MD, and Xinghui Liu, MD

OBJECTIVE: To evaluate whether sustained transabdo- RESULTS: Of 2,340 eligible women, 1,170 were random-
minal uterine massage can reduce blood loss after ized to oxytocin plus uterine massage and 1,170 to the
vaginal delivery. oxytocin-only group. Baseline characteristics were simi-
METHODS: In this multicenter randomized controlled lar in both groups. The incidence of blood loss of 400 mL
trial, eligible women who had delivered vaginally were or more in the 2 hours after delivery was not significantly
randomly assigned to receive 10 units oxytocin intra- different between the two groups (143/1,170 [12.2%]
muscularly immediately after delivery of the shoulder compared with 144/1,170 [12.3%]; relative risk 0.99, 95%
plus 30 minutes of sustained transabdominal uterine confidence interval 0.88–1.13) according to intent-to-
massage after delivery of the placenta or to 10 units treat analysis with a power of more than 0.8. No signif-
oxytocin intramuscularly alone. The primary outcome icant differences were found in the secondary outcomes.
was blood loss of 400 mL or more in the 2 hours after CONCLUSION: In patients delivered vaginally, trans-
delivery of the neonate. Secondary outcomes included abdominal uterine massage after delivery of the placenta
blood loss of 1,000 mL or more, blood loss in the 2 hours in addition to oxytocin does not reduce blood loss when
after delivery, use of therapeutic uterotonics or other compared with administration of oxytocin alone.
hemostatic procedures, hemoglobin of lower than 80 g/L CLINICAL TRIAL REGISTRATION: Chinese Clinical Trial
before discharge, and need for blood transfusion. Anal- Registry, www.chictr.org, ChiCTR-TRC-11001763.
ysis was by intent to treat. With a one-sided a of 0.05 and (Obstet Gynecol 2013;122:290–5)
a power of 0.8, a sample size of 1,061 women per group DOI: 10.1097/AOG.0b013e3182999085
was calculated to detect a 3% absolute decrease in the
LEVEL OF EVIDENCE: I
primary outcome.

From the Departments of Obstetrics and Gynecology, West China Second


University Hospital of Sichuan University, Chengdu, Southwest Hospital of
Third Military Medical University, Chongqing, Shanghai First Maternity and
P ostpartum hemorrhage is a major cause of mater-
nal death and severe morbidity, particularly in
low-resource countries.1 Data from the Chinese
Infant Hospital of Tongji University, Shanghai, and Women’s Hospital School of National Maternal and Child Mortality Surveillance
Medicine of Zhejiang University, Hangzhou, China.
System indicate that postpartum hemorrhage contrib-
Funded by a grant from the Science and Technology Department of Sichuan Prov-
ince for the Prevention and Treatment of Postpartum Hemorrhage Program uted to 31.5% (997/3,164) of all maternal deaths from
(2010FZ0078) and a grant from the Ministry of Health of China (201002013). 1996 to 2006, making it the leading cause of maternal
The authors thank Hao Ying, Ming Liu, and Cheng Liang for assistance with mortality in China.2
study design; Professor Guanjian Liu for assistance with data analysis; Xiaofen The World Health Organization (WHO), together
Pu, Tangchun Li, the Labor and Delivery nurses, and the residents of the
Department of Obstetrics and Gynecology at each study center for participant
with the International Confederation of Midwives and
enrollment; and Shawna Williams for careful revision of the manuscript. the International Federation of Gynecology and
Corresponding author: Xinghui Liu, MD, Department of Obstetrics and Obstetrics recommends active management of the third
Gynecology, West China Second University Hospital of Sichuan University, stage of labor to prevent postpartum hemorrhage. The
Section 3 No. 20, Renmin Road South, Chengdu 610041, China; e-mail: recommended measures include prophylactic use of
xinghuiliu@163.com.
uterotonics after delivery of the shoulder and con-
Financial Disclosure
The authors did not report any potential conflicts of interest. trolled cord traction and uterine massage after delivery
of the placenta.3,4 The effectiveness of uterotonics in
© 2013 by The American College of Obstetricians and Gynecologists. Published
by Lippincott Williams & Wilkins. preventing postpartum hemorrhage has been well es-
ISSN: 0029-7844/13 tablished.5–7 Recently, Gülmezoglu et al8 conducted

290 VOL. 122, NO. 2, PART 1, AUGUST 2013 OBSTETRICS & GYNECOLOGY
a large, multicenter, noninferiority, randomized con- questioning the woman. Baseline information was
trolled trial that justified the omission of controlled collected from each participant.
cord traction from active management of the third stage The participants were randomized into an oxyto-
of labor. However, the effectiveness of uterine massage cin plus uterine massage group and an oxytocin-only
remains unclear. group shortly after delivery of the placenta. The
Two randomized controlled trials assessed the random allocation sequence was computer-generated
effectiveness of uterine massage for preventing post- at West China Second University Hospital. Random-
partum hemorrhage after vaginal delivery with conflict- ization was stratified by each participating hospital
ing results.9,10 However, one trial was underpowered according to its annual number of childbirths (ie,
because of a small sample size and the other investigated a 1.4:1.4:1.4:1.0 ratio) and restricted with a random
uterine massage applied before rather than after delivery block of six. Numbered opaque envelopes containing
of the placenta. Therefore, we performed a multicenter randomized allocations were kept in the labor room in
randomized controlled trial to estimate the effectiveness each study site. As a result of the nature of the
of sustained transabdominal uterine massage, started intervention, neither participants nor research staff
after delivery of the placenta, in reducing blood loss could be blinded to group allocation.
after vaginal delivery. In both groups, 10 units of oxytocin were given
intramuscularly immediately after delivery of the shoul-
MATERIALS AND METHODS der and controlled cord traction was performed to assist
This was a randomized controlled trial conducted in placental delivery for all participants, per WHO guide-
four university hospitals (West China Second Univer- lines.3 The umbilical cord was clamped and cut approx-
sity Hospital of Sichuan University, Southwest Hos- imately 1 minute after delivery of the neonate in all
pital of Third Military Medical University, Shanghai study sites. The uterine fundus was rubbed and blood
First Maternity and Infant Hospital of Tongji Univer- clots expelled as quickly as possible after delivery of the
sity, and Women’s Hospital School of Medicine Zhe- placenta. Once the placenta was delivered, the next
jiang University) in China between March 2012 and numbered opaque envelope was opened and the alloca-
November 2012. The protocol was approved by tion revealed. Those allocated to the oxytocin-only
Ethics Committee of West China Second University group were managed expectantly, whereas women allo-
Hospital of Sichuan University (approval date March cated to the uterine massage group were provided with
16, 2012, approval number M-2012-005). This trial is 30 minutes sustained transabdominal uterine massage
registered with one of the primary registries in the starting promptly after placental delivery. At least two
WHO Registry Network, Chinese Clinical Trial Reg- research staff stayed with the participant to ensure
istry (ChiCTR.org#ChiCTR-TRC-11001763). All 30-minute sustained transabdominal uterine massage.
participants provided written informed consent. The massage was performed as follows: finding the uter-
Women who were expected to deliver vaginally ine fundus, manually stimulating the fundus and the
were evaluated for potential participation. Consent whole body of the uterus using fingers and palms
was obtained before full dilation of the cervix if the steadily and repetitively, and trying not to cause discom-
woman was eligible for recruitment and willing to fort to the woman. Postpartum hemorrhage was treated
participate after discussing the study with a midwife or according to the local policy of each study site, mainly
a resident. Inclusion criteria included women giving based on WHO guidelines.11 All participants were dis-
birth vaginally, aged between 20 and 35 years, with charged no earlier than 24 hours after delivery.
a singleton pregnancy, gestational age of 36 or more The procedure for collection and weighing of lost
weeks, and with fewer than three previous childbirths. blood was similar to that of a previous study.12 Col-
Exclusion criteria included fetal malpresentation, lection of lost blood was initiated immediately after
emergent cesarean delivery, the third stage of labor delivery of the neonate by putting a drape under the
lasting more than 30 minutes, a previous cesarean woman’s buttocks. Blood collected was weighed on an
delivery, three or more previous induced abortions, electronic scale together with the drape, and the
hypertensive disorders of pregnancy, fetal death, an amount was recorded in grams after subtracting the
amniotic fluid index of 20 cm or more, hemoglobin of weight of the drape. The amount of blood loss was
90 g/L or less before delivery, coagulopathy, and recorded 2 hours after delivery of the neonate. An
having an abdominal wall too thick to palpate the additional drape was placed under the woman’s but-
fundus of the uterus or to perform uterine massage tocks whenever needed. The amount of lost blood in
after delivery. Screening for eligibility was accom- grams was converted to volume by dividing by 1.06
plished by checking the medical record and directly (blood density in g/mL) for the analysis.13

VOL. 122, NO. 2, PART 1, AUGUST 2013 Chen et al Uterine Massage After Vaginal Delivery 291
The primary outcome was blood loss of 400 mL or Women assessed
more in the 2 hours after delivery of the neonate. for eligibility
N=3,829
Secondary outcomes were blood loss of 1,000 mL or Excluded: n=1,489
Ineligible: 776
more in the 2 hours after delivery, blood loss in Declined participation: 713
milliliters in the 2 hours after delivery, use of thera- Participants
randomized
peutic uterotonics, use of other hemostatic procedures n=2,340
(eg, uterine tamponade, bimanual compression of the
uterus, surgical procedures, uterine artery emboliza- 10 units oxytocin 10 units oxytocin
tion) for postpartum hemorrhage, hemoglobin lower and uterine n=1,170
massage
than 80 g/L before discharge, and need for blood n=1,170
transfusion.
Protocol violation Protocol violation
The investigators collected the data and entered n=16 n=7
them into a database in EpiData 3.1 in a double-entry
Received Received
and validation manner, ie, two investigators entered allocated allocated
the data independently and all inconsistent data were intervention intervention
n=1,154 n=1,163
resolved by checking the participants’ obstetric and
nursing records. Accuracy of information was ensured Analyzed Analyzed
by checking each participant’s medical records. n=1,170 n=1,170
The sample size was determined according to the Fig. 1. Flow of participants through the study.
results of our previous study, which showed a 9.6% Chen. Uterine Massage After Vaginal Delivery. Obstet Gynecol
incidence of blood loss of 500 mL or more within 24 2013.
hours after a vaginal delivery.14 We assumed the inci-
dence of blood loss of 400 mL or more within 2 hours
after vaginal delivery to be approximately this high. was high in both groups: 98.6% (1,154/1,170) in the
On the basis of this, inclusion of at least 1,061 women uterine massage group and 99.4% (1,163/1,170) in the
in each group would be required to detect a reduction oxytocin-only group, respectively. Massage was dis-
from 9.6% to 6.6% in the primary outcome in the continued in 16 women in the uterine massage group
uterine massage group with a one-sided a of 0.05 because of discomfort when they were receiving uter-
and a power of 0.8. Factoring in a 10% dropout rate, ine massage. In the oxytocin-only group, seven women
a total of 1,170 women would be required in each arm received sustained uterine massage and bimanual uter-
for adequate power. ine compression for the treatment of postpartum hem-
Data in the EpiData database were transferred into orrhage. No woman was lost to follow-up in the study.
SPSS 21.0 for analysis. Analysis was by intent to treat; There were no significant differences between the
participants were analyzed in the groups to which they two groups with regard to baseline characteristics
were initially randomized no matter whether they including maternal age, height, weight at admission,
received the assigned intervention or not. Per-protocol gestational age at delivery, weight of the newborn or
analysis was also performed to compare outcomes use of labor induction, operative vaginal delivery,
between the two groups. Categorical data were ana- episiotomy or perineal tear, length of labor, manual
lyzed with Pearson’s x2 test or Fisher’s exact test where removal of placenta, use of curettage, or hemoglobin
appropriate and continuous data were analyzed with before delivery (Table 1). Most of the participants
Student’s t test. Relative risks (RRs) and 95% confi- were primiparous women and received episiotomy,
dence intervals (CIs) of all outcomes are reported. and approximately half received labor analgesia.
The threshold for statistical significance was set at Intent-to-treat analysis showed that the incidence
P5.05. of blood loss of 400 mL or more in the 2 hours after
delivery of the neonate was not significantly different
RESULTS between the two groups (12.2% compared with 12.3%;
Between March 2012 and November 2012, a total of RR 0.99, 95% CI 0.88–1.13, P5.95) (Table 2). The
3,829 women were assessed for eligibility, and 2,340 average amount of blood loss in the 2 hours after deliv-
were included in our study. They were randomized ery was higher in the uterine massage group than in the
into the oxytocin plus uterine massage group (1,170 oxytocin-only group, but the difference was not statis-
women) or the oxytocin-only group (1,170 women). tically significant. The incidences of blood loss of
Figure 1 shows participant flow through this trial. 1,000 mL or more in the 2 hours after delivery, admin-
Overall, the adherence to the allocated intervention istration of therapeutic uterotonics, other hemostatic

292 Chen et al Uterine Massage After Vaginal Delivery OBSTETRICS & GYNECOLOGY
Table 1. Baseline Characteristics of Participants the primary nor any of the secondary outcomes dif-
fered significantly between the two groups.
Oxytocin Plus In the uterine massage group, 378 (32.3%) women
Uterine Oxytocin reported pain or discomfort when receiving uterine
Massage Only
Characteristic (n51,170) (n51,170) massage and 16 (1.4%) asked to have massage
discontinued as a result of discomfort. No severe
Age (y) 28.562.7 28.462.9 maternal morbidity such as admission to the intensive
Maternal height (cm) 161.364.5 161.464.5 care unit, sepsis or hysterectomy, or maternal death
Maternal weight at 66.767.4 67.267.8
admission (kg)
occurred in this trial.
Gestational age (wk) 39.561.1 39.461.1
Weight of newborn (g) 3,292.86348.9 3,301.86346.4
DISCUSSION
Primiparous 1,010 (86.3) 1,003 (85.7)
Previous induced abortion 369 (31.5) 398 (34.0) Uterine massage after delivery of the placenta is a part
Labor induction 177 (15.1) 195 (16.7) of active management of the third stage of labor
Operative 35 (3.0) 39 (3.3) according to the guidelines of WHO and the Interna-
vaginal delivery
tional Confederation of Midwives and the Interna-
Episiotomy or perineal 1,062 (90.8) 1,041 (89.0)
tear requiring suture tional Federation of Gynecology and Obstetrics.3,4 It
Labor analgesia 572 (48.9) 596 (50.9) may not be routinely used in developed countries
Duration of cervical 7.663.7 7.463.6 where effective preventive and therapeutic uterotonics
dilation from 2 cm are readily available, whereas in many underre-
to 10 cm (h)
sourced areas (eg, Egypt, Thailand, and Uganda), it
Duration of second 56.8648.3 57.3645.4
stage of labor (min) remains a routine practice.8 The results of our study
Duration of third stage 7.164.8 7.365.2 indicate there may be no need for routine uterine
of labor (min) massage after vaginal delivery, because it neither
Manual removal of 97 (8.3) 103 (8.8) reduced the amount of blood loss nor decreased the
placenta
incidence of the primary and secondary outcomes.
Uterine curettage for 62 (5.3) 44 (3.8)
retained placenta Instead, both the incidence of use of therapeutic ute-
Hemoglobin before 112.0624.4 111.8626.6 rotonics and the average amount of blood loss in the
delivery (g/L) 2 hours after delivery were higher in the uterine mas-
Data are mean6standard deviation or n (%). sage group, although the differences between the
groups were not statistically significant.
procedures for postpartum hemorrhage, hemoglobin Only two previous randomized controlled trials
of lower than 80 g/L before discharge, or blood trans- assessed the effectiveness of uterine massage in
fusion also did not differ significantly between the two preventing postpartum hemorrhage, and they were
groups. Per-protocol analysis also showed that neither conducted by the same research team. The earlier trial

Table 2. Outcomes by Intent-to-Treat Analysis

Oxytocin Plus
Uterine Oxytocin Only Relative Risk
Outcomes Massage (n51,170) (n51,170) (95% CI) P

Primary outcome
Blood loss 400 mL or more in the 2 h after delivery 143 (12.2) 144 (12.3) 0.99 (0.88–1.13) .95
Secondary outcomes
Blood loss 1,000 mL or more in the 2 h after 5 (0.4) 6 (0.5) 0.92 (0.53–1.57) .76
delivery
Blood loss in mL in the 2 h after delivery* 266.6 (146.5) 259.3 (143.8) 7.2 (24.5 to 19.0) .23
Therapeutic uterotonics 225 (19.2) 210 (17.9) 1.04 (0.94–1.16) .43
Other hemostatic procedures 7 (0.6) 9 (0.8) 0.78 (0.29–2.08) .62
Hemoglobin lower than 80 g/L before discharge† 7 (0.9) 5 (0.6) 1.43 (0.46–4.50) .58
Blood transfusion 7 (0.6) 9 (0.8) 0.78 (0.29–2.08) .62
CI, confidence interval.
Data are n (%) or mean (standard deviation) unless otherwise specified.
* Mean difference (95% confidence interval) is presented for blood loss in milliliters in the 2 hours after delivery.

Hemoglobin after childbirth was obtained before discharge for 807 participants in the oxytocin plus uterine massage group and 827
participants in the oxytocin-only group.

VOL. 122, NO. 2, PART 1, AUGUST 2013 Chen et al Uterine Massage After Vaginal Delivery 293
reported that mean blood loss was reduced at 30 mi- Despite these strengths, our study has several
nutes (168.8 mL compared with 210.4 mL, P5.02) and limitations. First, our study would be underpowered if
60 minutes (204.3 mL compared with 281.7 mL, we had used blood loss of 1,000 mL or more (ie,
P,.001) after delivery, and fewer women needed addi- severe postpartum hemorrhage) after delivery as the
tional uterotonics (6% compared with 25%; RR 0.20, primary outcome as other studies had.8,20,21 Second,
95% CI 0.08–0.50, P,.001), but the incidence of blood there was potential bias because blinding was impos-
loss of over 500 mL was not reduced (5% compared sible. Third, this trial was carried out in four university
with 7%; RR 0.52, 95% CI 0.16–1.67) in the uterine hospitals where effective uterotonics and other hemo-
massage group.9 However, this trial only included 200 static methods for treating postpartum hemorrhage
women and therefore was underpowered to detect a dif- were readily available, so clinical practitioners should
ference between the two groups with regard to inci- be cautious when applying our findings in resource-
dence of blood loss of over 500 mL. For this reason, poor areas.
the same team conducted another randomized con- Our findings indicate that routine uterine massage
trolled trial with a total of 1,964 women and found that provides no additional benefit when combined with
uterine massage was inferior to oxytocin in reducing oxytocin administration and therefore may not be
blood loss after delivery and that massage did not bring a necessary step for the prevention of postpartum
about additional benefit when oxytocin was adminis- hemorrhage after vaginal delivery. Performing uterine
tered.10 Our findings are partly in accordance with those massage for every woman is a time-consuming and
of the latter trial. The difference is that we started uter- strenuous procedure. Elimination of routine uterine
ine massage after delivery of the placenta in accordance massage from active management of the third stage of
with international guidelines, whereas in the previous labor will help obstetric staff spare more time and
trial, massage was performed before delivery of the pla- efforts for other work.
centa. The frequency of the use of therapeutic uteroton-
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