S
imões
R
et
al
.
394
R
ev
A
ssoc
M
ed
B
ras
2015; 61(5):391-402
1. Hannah et al. (
A
).
8
•
•
Design: multicenter randomized controlled clini-
cal study involving 121 centers distributed in 26
countries, known as term breech trial (TBT).
•
•
Population: 2,088 women in labor of a term single-
ton fetus (gestational age ≥ 37 weeks) in complete
or incomplete breech position (except those with
evidence of cephalopelvic disproportion, estima-
ted fetal weight greater than or equal to 4,000g, ce-
phalic hyperextension, fatal fetal congenital ano-
maly, contraindication to vaginal delivery [low lying
placenta]), were randomized to elective cesarean
delivery n=1,041 (performed with gestational age
equal to or greater than 38 weeks) or planned va-
ginal delivery (n=1,042).
•
•
Outcome: assessing, as the primary outcome, peri-
natal and neonatal morbidity and mortality up to
28 days after birth, excluding cases related to fatal
congenital anomalies. The analysis included birth
trauma (bone fractures, subdural hematoma, brain
or intraventricular hemorrhage), spinal cord injury,
peripheral nerve injury, seizure (within 24 hours of
birth or need for two or more drugs to control),
Apgar score <4 at five minutes, hypotonia, intuba-
tion or need for ventilation for at least 24 hours,
need for tube feeding for four days or longer, ad-
mission into neonatal intensive care unit for lon-
ger than four days.
As a secondary outcome, to evaluate maternal mor-
bidity and mortality during the first six weeks post-
partum (including maternal death, severe bleeding,
need for blood transfusion, need for uterine curet-
tage due to presence of ovular debris, hysterectomy,
need for surgical treatment of vulvar or perineal
hematoma, pulmonary embolism, pneumonia, in-
fection, fever (not including the first 24 hours post-
partum), bowel, bladder or ureter injury requiring
surgical treatment, genital tract fistulas).
•
•
Result: of the 1,041 pregnant women randomized
to elective cesarean section, 941 (90.4%) underwent
the procedure; among those randomized to plan-
ned vaginal delivery (n=1,042), only 591 underwent
the procedure (56.7%). The authors found a lower
frequency of perinatal and neonatal morbidity and
mortality in patients referred to elective cesarean
delivery over planned vaginal delivery (factors such
as trauma at birth [RRA=0.017 with 95CI: 0.004 to
0.027]; seizure [RRA=0.011 with 95CI: 0.002 to
0.013]; hypotonia [RRA=0.028 with 95CI: 0.016 to
0.033]; Apgar < 7 at 5 minutes [RRA=0.044 with
95CI: 0.027 to 0.055]; intubation or need for ven-
tilation for at least 24 hours [RRA=0.019 with 95CI:
0.007 to 0.025]) were significantly reduced among
women undergoing cesarean delivery.
Regarding the secondary endpoints analyzed (ma-
ternal morbidity and mortality), no significant dif-
ferences were identified between the groups.
2. Hannah et al. (
B
).
9
•
•
Design: multicenter randomized controlled clini-
cal study involving 121 centers distributed in 26
countries, known as term breech trial (TBT).
•
•
Population: 2,088 women pregnant with a term sin-
gleton fetus (gestational age ≥ 37 weeks) in com-
plete or incomplete breech position (except those
with evidence of cephalopelvic disproportion [es-
timated fetal weight greater than or equal to 4,000g],
cephalic hyperextension, fatal fetal congenital ano-
maly, contraindication to vaginal delivery [low lying
placenta]), were randomized to elective cesarean
delivery n=1,041 (performed with gestational age
equal to or greater than 38 weeks) or planned va-
ginal delivery (n=1,042).
•
•
Outcome: to evaluate, by means of a questionnai-
re, complaints of urinary and fecal incontinence,
and flatus, and to analyze breastfeeding, sexual and
emotional relationship with husband/partner, post-
partum depression, satisfaction related to the birth
experience, and pain (perineal, abdominal) after th-
ree months from birth.
•
•
Result: 972 pregnant women randomly assigned to
elective cesarean delivery and 962 patients rando-
mized to the planned vaginal delivery were follo-
wed for three months providing answers to the
questionnaire. Regarding complaints of urinary in-
continence, the authors found that these were sig-
nificantly less frequent among patients submitted
to elective cesarean delivery (n=27 of 725 patients)
than among those undergoing planned vaginal
birth (n=35 of 456 patients) with RRA=0.04 (95CI:
0.01 a 0.06). For the other outcomes analyzed, no
significant differences between the delivery modes
were identified.
3. Golfier et al. (
B
).
10
•
•
Design: non-concurrent observational longitudi-
nal study.
•
•
Population: medical records of 1,116 pregnant wo-
men (nulliparous and multiparous) with singleton
fetus at term (gestational age between 37 and 42