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A RCT of Foley Bulb For Labor Induction in PROM PDF
A RCT of Foley Bulb For Labor Induction in PROM PDF
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BACKGROUND: In premature rupture of membranes (PROM), the risk RESULTS: A total of 128 women were randomized. Baseline char-
of chorioamnionitis increases with increasing duration of membrane acteristics were similar between groups. We found no difference in
rupture. Decreasing the time from PROM to delivery is associated with induction-to-delivery time between women induced with concurrent
lower rates of maternal infection. The American College of Obstetricians Foley bulb/oxytocin vs oxytocin alone (median time 13.0 hours [inter-
and Gynecologists suggests that all women with PROM who do not have a quartile 10.7, 16.1] compared with 10.8 hours [interquartile range
contraindication to vaginal delivery have their labor induced instead of 7.8, 16.6], respectively, P ¼ .09). There were no significant differences
being managed expectantly. Although the use of oxytocin for labor in- in mode of delivery, rates of postpartum hemorrhage, chorioamnionitis,
duction has been demonstrated to decrease the time to delivery compared or epidural use. Both groups had similar rates of tachysystole as well as
with expectant management, no studies have evaluated the effectiveness total oxytocin dose. There were no differences in neonatal birth weight,
of cervical ripening with a Foley bulb to additionally decrease the time to Apgar scores, cord gases, or admissions to the neonatal intensive care
delivery. unit.
OBJECTIVE: To determine whether simultaneous use of an intra- CONCLUSION: This is the first randomized trial to compare
cervical Foley bulb and oxytocin decreases time from induction start to concurrent Foley bulb/oxytocin vs oxytocin alone in nulliparous
delivery in nulliparous patients with PROM compared with the use of patients undergoing induction of labor for PROM. We found no
oxytocin alone. difference in time from induction to delivery in patients induced with
STUDY DESIGN: A randomized trial was conducted from August 2014 concurrent Foley bulb/oxytocin vs oxytocin alone. In nulliparous
to February 2016 that compared the use of concurrent Foley bulb/oxytocin patients with PROM, this study suggests that addition of a Foley
vs oxytocin alone in nulliparous patients 34 weeks’ gestational under- bulb to oxytocin does not decrease the time from induction start to
going labor induction for PROM. Our primary outcome was time from delivery.
induction to delivery. Secondary outcomes were mode of delivery,
tachysystole, chorioamnionitis, postpartum hemorrhage, Apgar scores, Key words: Foley bulb, induction of labor, labor induction, nulliparous,
and admission to the neonatal intensive care unit. premature rupture of membranes, PROM
Amorosa et al. Foley for labor induction in PROM (FLIP). Am J Obstet Gynecol 2017. oxytocin group compared with the
oxytocin alone group (15.4 hours [IQR
FIGURE 2
Kaplan-Meier time curve for start of induction to delivery
There was no significant difference in time from induction start to delivery in nulliparous patients with PROM who were induced by the use of either a
combination of concurrent foley bulb plus oxytocin vs oxytocin alone.
PROM, premature rupture of membranes.
Amorosa et al. Foley for labor induction in PROM (FLIP). Am J Obstet Gynecol 2017.
13.2, 17.5] in the Foley bulb plus patients with PROM who were induced specifically address these outcomes, and
oxytocin group vs 11.8 hours [IQR 9.4, with a combination of a Foley bulb plus the overall numbers were small. In
14.2] in the oxytocin alone, P ¼ .02). oxytocin vs oxytocin alone. Although addition, no differences were found in
There were no differences in neonatal no significant differences were observed adverse neonatal outcomes such as
birth weight, Apgar scores, or admission in mode of delivery, labor complica- admission to the NICU, cord gas values,
to the neonatal intensive care unit tions, or maternal adverse outcomes or Apgar scores. Among patients who
(Table 4). Umbilical cord gases were such as chorioamnionitis and post- started their induction at 0 cm dilation,
similar in the 2 groups. partum hemorrhage, twice as many patients who were induced with a
patients in the Foley plus oxytocin combination of Foley bulb plus
Comment group had a postpartum hemorrhage or oxytocin had a significantly longer time
There was no difference in the time delivery affected by chorioamnionitis. to delivery than those who received
from start of induction until delivery in However, this study was not powered to oxytocin alone; however, the number of
TABLE 3
Median time and IQR in hours from start of induction to delivery by maternal characteristics
Foley þ oxytocin, Oxytocin alone,
Characteristic n median hours (IQR) N median hours (IQR) P valuea
Mode of delivery
Vaginal 43 13.2 (10.8, 15.9) 50 10.6 (7.1, 14.2) .02
Cesarean delivery 18 12.3 (10.5, 17.0) 16 16.0 (9.8, 18.2) .57
Dilation
0 13 15.4 (13.2, 17.5) 14 11.8 (9.4, 14.2) .02
1e2 47 12.0 (10.1, 15.9) 35 11.0 (8.2, 17.7) .86
Maternal prepregnancy BMI
<18.5 3 7.0 (5.2, 15.9) 1 6.1 1.0
18.5 and <25 35 13.0 (10.8, 15.2) 46 10.8 (7.2, 16.7) .14
25 to <30 16 12.2 (10.2, 16.3) 11 11.3 (8.7, 16.6) .86
30þ 7 18.5 (11.3, 21.1) 7 10.7 (5.9, 15.1) .15
BMI, body mass index; IQR, interquartile range.
a
Analyzed with the Wilcoxon Rank Sum test.
Amorosa et al. Foley for labor induction in PROM (FLIP). Am J Obstet Gynecol 2017.
patients in this group was very small. A Membrane rupture is associated with cervical examination before the start of
subgroup analysis of the patients who prostaglandin release locally at the site their oxytocin because of provider
began their induction at 0 cm dilation of the membrane—this mechanism preference. It is possible that this subset
showed similar doses of total oxytocin alone is enough to trigger labor onset in of patients had a more favorable Bishop
whether they received oxytocin alone or most patients, as 60% will go into labor score than the other patients enrolled in
oxytocin with concurrent Foley balloon. within 24 hours and 95% within 72 the study and could have skewed the
To our knowledge, there have been no hours.1,13 It is plausible that the pros- results to shorter induction times in the
previous studies specifically comparing taglandin release thought to be stimu- oxytocin alone group as a whole. This is
the concurrent use of oxytocin and Foley lated by the Foley balloon is not unlikely however, as we compared the
bulb with oxytocin alone for labor in- necessary as perhaps the optimal phys- patients who had an initial examination
duction in patients with PROM. There iologic amount already is released at in the oxytocin alone group vs those
have been other studies that compared time of membrane rupture. who did not have an initial examination
other dual agent inductions in PROM. There are several limitations to this and found similar total times from in-
Our finding that concurrent Foley and study. First, 17 of 66 patients in the duction start to delivery. In the 49
oxytocin compared with oxytocin alone oxytocin-alone group did not have a women who had a cervical examination
did not shorten induction times is
similar to the results of a study by Tan
et al,12 in which concurrent dinopro-
stone and oxytocin was compared TABLE 4
against induction with oxytocin alone in Neonatal outcomes
term PROM patients. They randomized Foley þ oxytocin Oxytocin alone
116 term, nulliparous patients with Characteristics n ¼ 61 (%) n ¼ 66 (%) P value
PROM to receive either 3 mg of dino- Birth weight, g, mean (SD) 3163.6 (457.5) 3101.8 (500.5) .47a
prostone pessary plus oxytocin vs a
1-minute Apgar score, median (IQR) 9 (9, 9) 9 (9, 9) .14b
placebo plus oxytocin. There was no
significant difference in time from in- 5-minute Apgar score, median (IQR) 9 (9, 9) 9 (9, 9) .18b
duction to delivery between the 2 groups. Admission to the NICU 4 (7) 8 (12) .37c
Similar to our study, there also were Cord gas pH, mean (SD) 7.25 (0.06) 7.25 (0.07) .77a
no significant differences in mode of
IQR, interquartile range; NICU, neonatal intensive care unit.
delivery and rates of postpartum hem- a
Analyzed with the Student t test; b Analyzed with the Wilcoxon rank-sum test; c Analyzed with the Fisher exact test.
orrhage. There were also no differences Amorosa et al. Foley for labor induction in PROM (FLIP). Am J Obstet Gynecol 2017.
in Apgar scores and NICU admissions.
before the start of their oxytocin, the Many obstetrical providers question 5. Dare MR, Middleton P, Crowther CA,
median time from the start of induction whether the introduction of the Foley Flenady VJ, Varatharaju B. Planned early birth
versus expectant management (waiting) for
to delivery was 11.0 hours (IQR 8.4 bulb in patients with PROM may in- prelabour rupture of membranes at term (37
hours, 16.6 hours). In the 17 women crease rates of maternal complications weeks or more). Cochrane Database Syst Rev
who did not have a cervical examina- such as infection and postpartum hem- 2006;(1):CD005302.
tion before the start of their oxytocin, orrhage. Although twice as many pa- 6. ACOG Committee on Practice Bulletins—
the median time form the start of in- tients in the Foley plus oxytocin group Obstetrics. ACOG Practice Bulletin No. 107:
induction of labor. Obstet Gynecol 2009;114:
duction to delivery was 10.8 hours had their delivery complicated by either 386-97.
(IQR 6.1 hours, 14.3 hours). There was chorioamnionitis or postpartum hem- 7. Connolly KA, Kohari KS, Rekawek P, et al.
no statistical difference in these times orrhage in this study, the overall A randomized trial of Foley balloon induction of
based on the Wilcoxon rank sum test numbers were small, and the difference labor trial in nulliparas (FIAT-N). Am J Ostet
(P ¼ .44). did not meet statistical significance. A Gynecol 2016;215:392.e1-6.
8. Levine L, Downes K, Elovitz M, Parry S,
Second, there is a potential for selec- much larger study would be needed to Sammel M, Srinivas S. Mechanical and
tion bias in our study—we do not have address these specific questions. pharmacologic methods of labor induction.
data available to compare the women We found no difference in time from Obstet Gynecol 2016;128:1357-64.
with PROM who participated in our induction to delivery in nulliparous pa- 9. Pettker CM, Pocock SB, Smok DP, Lee SM,
study with all women with PROM at our tients with PROM who were induced Devine PC. Transcervical Foley catheter with
and without oxytocin for cervical ripening: a
institution. Another potential imitation either using a combination of concur- randomized controlled trial. Obstet Gynecol
of the study has to do with institution- rent Foley bulb plus oxytocin versus 2008;111:1320-6.
specific protocols. Our oxytocin proto- oxytocin alone. These findings address a 10. Sanchez-Ramos L, Chen AH, Kaunitz AM,
col for labor induction may vary from frequently asked question about whether Gaudier FL, Delke I. Labor induction with intra-
other institutions and our protocol is to there is utility in using Foley bulbs to vaginal misoprostol in term premature rupture of
membranes: a randomized study. Obstet
fill Foley bulbs to 60 cc, whereas other assist with cervical ripening in patients Gynecol 1997;89:909-12.
institutions may use other standard with PROM in an effort to shorten the 11. Carbone JF, Tuuli MG, Fogertey PJ,
volumes. duration of labor induction. This study Roehl KA, Macones GA. Combination of Fo-
This study used a sample size calcu- suggests that Foley bulbs should not be ley bulb and vaginal misoprostol compared
lation that was based on the assumption used in induction of labor for PROM in with vaginal misoprostol alone for cervical
ripening and labor induction: a randomized
that times from the start of induction to nulliparous patients, as no additional controlled trial. Obstet Gynecol 2013;121:
delivery would be normally distributed. benefit is conferred. n 247-52.
The times from the start of induction to 12. Tan PC, Daud SA, Omar SZ. Concurrent
delivery observed in this study were not References dinoprostone and oxytocin for labor induction in
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that the addition of Foley does not 3. Soper DE, Mayhall CG, Froggatt JW. Char-
decrease time from the start of induc- acterization and control of intraamniotic infection Author and article information
tion to delivery, which was the clinically in an urban teaching hospital. Am J Ostet From the Division of Maternal Fetal Medicine, Department
relevant outcome we were studying. Gynecol 1996;175:304-9. discussion 309-10. of Obstetrics, Gynecology and Reproductive Science,
Based on the results of this study, the 4. Hannah ME, Ohlsson A, Farine D, et al. In- Mount Sinai Hospital, New York, NY.
duction of labor compared with expectant Received March 4, 2017; accepted April 24, 2017.
addition of Foley is not recommended The authors report no conflict of interest.
management for prelabor rupture of the mem-
to shorten induction times in patients branes at term. TERMPROM Study Group. Corresponding author: Jennifer M. H. Amorosa, MD.
with PROM. N Engl J Med 1996;334:1005-10. amorje@valleyhealth.com