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OBSTETRICS
Randomized controlled trial of prolonged second stage:
extending the time limit vs usual guidelines
Alexis C. Gimovsky, MD; Vincenzo Berghella, MD
BACKGROUND: Guidelines for management of the second stage have Maternal and neonatal outcomes were compared secondarily. Statistical
been proposed since the 1800s and were created largely by expert analysis was done by intention-to-treat.
opinion. Current retrospective data are mixed regarding differences in RESULTS: Seventy-eight nulliparous women were assigned
maternal and neonatal outcomes with a prolonged second stage. There randomly. All of the women had epidural anesthesia. Maternal de-
are no randomized controlled trials that have evaluated whether extending mographics were not significantly different. The incidence of cesarean
the second stage of labor beyond current American College of Obstetri- delivery was 19.5% (n 8/41 deliveries) in the extended labor group
cians and Gynecologists recommendations is beneficial. and 43.2% (n 16/37 deliveries) in the usual labor group (relative
OBJECTIVE: The purpose of this study was to evaluate whether risk, 0.45; 95% confidence interval, 0.22e0.93). The number
extending the length of labor in nulliparous women with prolonged second needed-to-treat to prevent 1 cesarean delivery was 4.2. There were
stage affects the incidence of cesarean delivery and maternal and neonatal no statistically significant differences in maternal or neonatal morbidity
outcomes. outcomes.
STUDY DESIGN: We conducted a randomized controlled trial of CONCLUSION: Extending the length of labor in nulliparous women
nulliparous women with singleton gestations at 36 0/7 to 41 6/7 weeks with singleton gestations, epidural anesthesia, and prolonged second
gestation who reached the American College of Obstetricians and Gyne- stage decreased the incidence of cesarean delivery by slightly more
cologists definition of prolonged second stage of labor, which is 3 hours than one-half, compared with usual guidelines. Maternal or neonatal
with epidural anesthesia or 2 hours without epidural anesthesia. Women morbidity were not statistically different between the groups; however,
were assigned randomly to extended labor for at least 1 additional hour, our study was underpowered to detect small, but potentially clinical
or to usual labor, which was defined as expedited delivery via cesarean or important, differences.
operative vaginal delivery. The exclusion criteria were intrauterine fetal
death, planned cesarean delivery, age <18 years, and suspected major Key words: cesarean delivery, labor, prolonged second stage,
fetal anomaly. Primary outcome was incidence of cesarean delivery. randomized controlled trial, second stage of labor
sealed envelopes. The sequence was incidence of: vaginal delivery (SVD and birthweight, neonatal intensive care
generated by the primary investigator operative vaginal delivery [OVD] com- unit (NICU) admission, ventilation
(A.C.G.). Participants were consented bined), SVD, OVD, chorioamnionitis, support with the use of continuous
by labor and delivery providers in the endometritis, postpartum hemorrhage positive airway pressure or greater,
ofce or on admission. Women were (dened as >500 mL estimated blood sepsis, seizure, umbilical artery cord
assigned randomly to either extended loss in a vaginal delivery and >1000 mL pH <7.10, perinatal death, and NICU
care or usual care groups. Randomi- estimated blood loss in a CD), trans- length of stay.
zation was stratied by epidural status. fusion, third- and fourth-degree lacera- Race/ethnicity was classied by the
Suggested treatment for women who tion, and cervical laceration. study participants. The classications
were assigned randomly to the extended Neonatal secondary outcome mea- were non-Hispanic white, non-Hispanic
care group was continuing the second sures included shoulder dystocia, black, Asian, Hispanic, or other.
stage for at least 1 additional hour after
reaching the ACOG prolonged second
stage criteria (ie, after 3 hours in the FIGURE 1
second stage of labor with an epidural or Consolidated Standards of Reporting Trials flow diagram
2 hours without an epidural). Suggested
treatment for women who were assigned
randomly to the usual care group was
delivery soon after reaching the criteria
for prolonged second stage listed by
ACOG. Women were assigned randomly
by labor and delivery staff at either the
3-hour mark (with epidural) or 2-hour
mark (without epidural).
Except for the suggested manage-
ment regarding length of the second
stage as per randomization, the second
stage of labor was managed according
to the individual provider on labor and
delivery. All patients were treated by
house staff under the supervision of an
attending physician. In general, on the
nding of complete dilation, women
without an urge to push were offered
delayed pushing (ie, waiting about 1
hour before starting to push). Once
pushing started, this usually was done
via Valsalva maneuver. Delayed pushing
was included in the total time of second
stage. After reaching ACOG criteria for
prolonged second stage, women in the
extended care group were given at least
1 additional hour to have a sponta-
neous vaginal delivery (SVD) then
delivered by the labor and delivery team
with the option of CD, forceps-assisted
vaginal delivery (FAVD), or vacuum-
assisted vaginal delivery (VAVD).
Women in the usual care group who
reached ACOG criteria for prolonged
second stage were at that point expe-
ditiously delivered by the labor and
delivery team with the option of CD, Flow diagram of study participants.
FAVD, or VAVD. NFRHT, nonreassuring fetal heart tracing.
Primary outcome was CD. Maternal Gimovsky & Berghella. Randomized controlled trial of prolonged second stage. Am J Obstet Gynecol 2016.
secondary outcome measures included
vention; however, there was a 14.1% Gimovsky & Berghella. Randomized controlled trial of prolonged second stage. Am J Obstet Gynecol 2016.
crossover rate (extended labor, 2; usual
labor, 9). Reasons for crossover in the
extended labor group were maternal crossover in the usual labor group women withdrew from the study. There
request (n 1) and nonreassuring fetal included maternal request (n 4) and was no loss to follow up. Figure 1 shows
heart tracing (n 1). Reasons for delivery provider decision (n 5). No the trial ow diagram.
TABLE 3
Neonatal outcomes
Extended labor Usual labor 95% Confidence
Outcome (n 41) ( n 37) Relative risk interval P value
Shoulder dystocia, n (%) 1 (2.4) 0 (0) Not estimable Not estimable
Birthweight, g a
3437 527 3506 534 .6b
Neonatal intensive care unit admission, n (%) 13 (31.7) 14 (37.8) 0.8 (0.46e1.54)
Continuous positive airway pressure or 1 (2.4) 3 (8.1) 0.3 (0.03e2.77)
greater, n (%)
Sepsis, n (%) 0 0
Seizure, n (%) 0 0
Umbilical artery cord pH <7.10, n (%) 0 0
Perinatal death, n (%) 0 0
Neonatal intensive care unit length of stay, d a
2.66 1.02 4.03 5.67 .3c
a
Data are given as mean standard deviation; Two sample t-test; Wilcox Rank-Sum test.
b c
Gimovsky & Berghella. Randomized controlled trial of prolonged second stage. Am J Obstet Gynecol 2016.
hours) second stage of labor, extending differences were found, postpartum There were differences in insurance
the second stage of labor decreases the hemorrhage, endometritis, and third- type and fetal position between groups.
incidence of CD by a signicant per- and fourth-degree lacerations all had We analyzed both of these possible
centage (55%) compared with usual la- wide condence intervals. This study was confounders and found that they had no
bor guidelines, from 43.2% with usual underpowered to determine differences interaction with the results. The effects
labor to 19.5% with extended labor. in these outcomes. Additionally, the time were in different directions for each in-
Importantly, the decrease in CD was difference between the 2 groups was not surance type and fetal position. Thus,
obtained without increasing maternal statistically signicantly different 92 65 there does not appear to be confound-
or neonatal morbidity. The number minutes vs 78 46 minutes; P .3). The ing, but this is more likely effect modi-
needed-to-treat to prevent 1 CD in this lack of time difference was contributed cation. The safety and effectiveness of
cohort of women was 4.2. by several factors that included the 14.1% prolonged second stage has been evalu-
There are several strengths of this overall crossover, time spent waiting for ated previously only in retrospective
study. First, the trial was designed as a operating rooms to be available, and studies. There are only 2 studies that
randomized controlled trial with an time waiting to set up for an OVD. specically report outcomes for nullip-
intention-to-treat analysis, and recruit- Nevertheless, the lack of time difference arous women with epidural anes-
ment of the desired women was com- and the presence of crossover strengthen thesia.7,9 In 1 retrospective review that
pleted. Second, there are no similar trials our results because of the analysis as included 548 nulliparous women with
in the literature on this subject. Third, intention-to-treat. It was the intention prolonged second stage and an epidural
there was no loss to follow up. Fourth, of extending the second stage of labor who were allowed to labor longer, the
there were no changes to the protocol to at least 4 hours that seemed to have CD rate (17.9%) was comparable with
during the trial. Fifth, the estimated contributed to the results. our extended labor results (19.5%).
incidence of CD of the extended labor The generalizability of this study A second larger retrospective study of
group that we used for our power calcu- was limited by the fact that no women 3533 nulliparous women with prolonged
lations was very similar as in the popu- without an epidural were assigned ran- second stage plus epidural who were
lation that was studied. Last, recruitment domly. Out of the entire cohort of allowed to labor longer also conrmed a
was relatively easy for this study; consents nulliparous women who presented to la- similar CD rate of 20.0%. In terms of
were obtained from 87.3% of the women bor and delivery during the study time maternal and neonatal morbidities, this
who were approached, which suggests period and did not have an epidural, only study showed rates of third- and fourth-
that most women are highly motivated 4 of 107 women (3.7%) had prolonged degree laceration of 8.8%, postpartum
to have an SVD. second stage >2 hours. Of these 4 women, hemorrhage of 7.3%, chorioamnionitis
Although we reached our pretrial none was consented for the trial. This is of 11.1%, endometritis of 1.2%, and a
goal for sample size, a potential limita- an important nding because it supports NICU admission rate of 7.1%. Impor-
tion of this study was the relatively previous studies that suggest that epi- tantly, our maternal and neonatal
small number of women who were in- dural anesthesia is a signicant contrib- complication incidences did not differ
cluded. Although no maternal morbidity utor to a prolonged second stage.11,12 by group. However, our incidences of
chorioamnionitis and NICU admission staff, attending physicians, and residents who maternal outcomes with prolonged second
in general were higher across both the helped with recruitment of women and who did not stage of labor. Obstet Gynecol 2014;124:57-67.
receive funding or compensation and Ben Leiby, 8. American College of Obstetricians and Gy-
extended labor and usual labor groups PhD, Division of Biostatistics, Department of necologists. Operative vaginal delivery. ACOG
than those found by prior studies, Pharmacology and Experimental Therapeutics, Practice Bulletin no.: 17. Washington (DC): The
although the ndings were similar for Sidney Kimmel Medical College at Thomas College; 2012.
the other outcomes. These ndings Jefferson University, who contributed to the data 9. Menticoglou SM, Manning F, Harman C,
could be explained by differences in our analysis and did receive nancial compensation Morrison I. Perinatal outcome in relation to
from the Division of Maternal Fetal Medicine. second-stage duration. Am J Obstet Gynecol
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Acknowledgments Obstet Gynecol 2009;201:357.e1-7. The authors report no conflict of interest.
We acknowledge Sidney Kimmel Medical College 7. Laughon SK, Berghella V, Reddy UM, Corresponding author: Alexis Gimovsky, MD. alexis.
at Thomas Jefferson University Labor and Delivery Sundaram R, Lu Z, Hoffman MK. Neonatal and gimovsky@jefferson.edu