A C TA Obstetricia et Gynecologica

AOGS M A I N R E SE A RC H A R TI C LE

Management of prolonged pregnancy by induction with a

Foley catheter
HEIDI KRUIT1, OSKARI HEIKINHEIMO1, VELI-MATTI ULANDER1, ANSA AITOKALLIO-TALLBERG1,
IRMELI NUPPONEN2, JORMA PAAVONEN1 & LEENA RAHKONEN1
1
2

Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Helsinki, and
Childrens Hospital, University of Helsinki and Helsinki University Hospital, Helsinki, Finland

Key words
Labor induction, Foley catheter, prolonged
pregnancy, cesarean delivery rate, nulliparous
women
Correspondence
Heidi Kruit, Department of Obstetrics and
Gynecology, Helsinki University Hospital,
Haartmaninkatu 2, 00029 HUS Helsinki,
Finland.
E-mail: heidi.kruit@hus.fi
Conflict of interest
The authors have stated explicitly that there
are no conflicts of interest in connection with
this article.
Please cite this article as: Kruit H,
Heikinheimo O, Ulander V-M, AitokallioTallberg A, Nupponen I, Paavonen J, et al.
Management of prolonged pregnancy by
induction with a Foley catheter. Acta Obstet
Gynecol Scand 2015; 94: 608614.
Received: 30 December 2014
Accepted: 4 March 2015

Objectives. To describe labor outcomes in women with prolonged pregnancy

and induction of labor with a Foley catheter, as compared with women with
spontaneous onset of labor. Design. Retrospective study. Setting. Helsinki University Hospital. Sample. 553 women with uncomplicated prolonged pregnancies between January 2011 and January 2012, divided into 303 women (54.8%)
with Foley catheter induction and 250 (45.2%) with spontaneous labor. Methods. Maternal and neonatal characteristics of women with uncomplicated singleton pregnancy of 41+5 weeks of gestation were analyzed. Main outcome
measures. Cesarean delivery rates, maternal and neonatal morbidity.
Results. The cesarean delivery rate was 30.7% (n = 93/303) in women with
labor induction and 4.8% (12/250) in women with spontaneous onset of labor
(p < 0.001). The cesarean delivery rate was 37.3% (91/244) among nulliparous
women with labor induction and 8.7% (11/126) among women with spontaneous labor, a sixfold increased risk (odds ratio 6.2). Among parous women,
cesarean section rates were low and not significantly different (3.4% vs. 0.8%,
p = 0.2). There were no differences in maternal intrapartum or postpartum
infection rates or adverse neonatal outcomes between the groups. Conclusions. Foley catheter induction of labor in prolonged pregnancy did not
increase maternal or perinatal morbidity compared with spontaneous onset of
labor but was associated with a considerably increased cesarean section rate,
particularly among nulliparous women.
Abbreviations:

GBS, Group B Streptococcus agalactiae; IOL, induction of labor.

DOI: 10.1111/aogs.12632

Introduction
The World Health Organization defines post-term pregnancy as one extending to 42+0 weeks (294 days) (1).
Post-term pregnancy occurs in approximately 5% of pregnancies, varying in reported frequency from 0.4 to 8.1%
in different countries (2). In Finland, 810% of all pregnancies extend beyond 41 weeks of gestation and the rate
of post-term pregnancy has ranged between 4.2 and 4.8%
during recent years (3,4). Post-term pregnancy is associated with maternal and fetal risks, raised rates of operative delivery, and increased perinatal mortality (5,6).

608

Key Message
Labor induction with Foley catheter in prolonged
pregnancy appears as safe as spontaneous labor in
terms of perinatal morbidity but is associated with a
high rate of cesarean delivery, particularly among nulliparous women. Given the major impact of the first
cesarean delivery on subsequent pregnancies, it is
important to optimize labor induction methods, not
least for nulliparous women.

2015 Nordic Federation of Societies of Obstetrics and Gynecology, Acta Obstetricia et Gynecologica Scandinavica 94 (2015) 608614

H. Kruit et al.

Labor induction in prolonged pregnancy

Post-term pregnancy is the most common indication for

labor induction (7). Nowadays, induction of labor (IOL)
is started before 42 weeks in many countries since several
clinical practice guidelines on the management of postterm pregnancy recommend elective induction and delivery by 41 completed weeks (1,8,9). While induction rates
have increased, the rates of post-term pregnancy have
decreased (8).
There is a concern that rising rates of IOL may increase
cesarean deliveries (10,11). However, it has been debated
whether the increased cesarean section rates are related to
the IOL or to the indication(s) for induction. In a
recently published Norwegian study, only insignificant
increases in the cesarean section rate were seen after a
change to a more liberal induction policy for prolonged
pregnancies (12). Furthermore, in a recent meta-analysis
the cesarean section rate in term and post-term pregnancies was lower among women with induced labor than in
women managed expectantly (13).
The Foley catheter method has been established for
IOL since it was first described in the early 1980s. Then,
it was used in conjunction with prostaglandin administration via the catheter (14). After 1990, additional studies
on the use of the Foley catheter for labor induction were
published. Recently, the Foley catheter has been shown to
result in a comparable vaginal delivery rate to that seen
following induction with prostaglandins in low-risk
women with an unfavorable cervical score at term
(15,16).
The aim of this study was to evaluate delivery outcomes
in prolonged pregnancies induced by Foley catheter.

Material and methods

This retrospective study of women with a prolonged
pregnancy of 41+5 gestational weeks between January
2011 and January 2012 (1 year) was conducted at the

Department of Obstetrics and Gynecology, Helsinki University Hospital, Finland. According to the departmental
management guidelines, all women with an uncomplicated prolonged pregnancy receive an appointment for an
antenatal visit in the maternity outpatient clinic at 41+5
weeks of gestation. The decision on IOL or expectant
management depends on an assessment of maternal and
fetal wellbeing and on maternal preference. Fetal wellbeing was examined by cardiotocography (non-stress test)
and ultrasonographic assessment of fetal growth, fetal
movements, and amniotic fluid volume (biophysical profile). Where expectant management was chosen, IOL was
scheduled no later than 42+1 weeks (4 days later) if spontaneous labor had not commenced. Since 2010, the Foley
catheter has been the main method of labor induction in
our department (17).
A total of 798 women with an uncomplicated singleton
pregnancy 41+5 weeks of gestation were identified from
the hospital database during the study year. Duration of
pregnancy was defined by the fetal crownrump length
measurement performed at the time of first trimester
ultrasound screening. We excluded 212 women with
breech presentation, a history of cesarean section or previous rupture of membranes in the current pregnancy
(Figure 1). Since we wanted to focus on Foley catheter
induction, a relatively new IOL method in our clinic at
the time, we also excluded women in whom other induction methods were used. The final database thus contained 553 deliveries, including 303 women (54.8%) with
Foley catheter IOL and 250 women (45.2%) with spontaneous labor by 42+1 weeks of gestation. In all cases the
main indication for IOL was prolonged pregnancy. The
study protocol was approved by the local Ethics Committee (No. 268/13/03/03/2012) and the management of the
Hospital district of Helsinki and Uusimaa.
In Foley catheter induction a single balloon catheter
(R
usch 2-way Foley Couvelaire tip catheter size 22 Ch,

Study population
n = 798
Primary exclusion (n = 212):
Previous cesarean section n = 79
Breech presentation
n=2
Amniotomy
n = 70
Prostaglandin
n = 61

Spontaneous labor
n = 250

Primiparous
n = 126

Multiparous
n = 124

Labor induction
n = 336

Primiparous
n = 244

Secondary exclusion:
Foley catheter +
prostaglandin
n = 33

Multiparous
n = 59

Figure 1. Flow chart of the study population.

2015 Nordic Federation of Societies of Obstetrics and Gynecology, Acta Obstetricia et Gynecologica Scandinavica 94 (2015) 608614

609

Labor induction in prolonged pregnancy

Teleflex Medical, Athlone, Ireland) was used. In 139

(45.9%) cases the catheter was inserted at gestational age
41+5, in 65 women (21.5%) at 41+6, in 83 (27.4%) at
42+0 and in 16 (5.2%) at 42+1 weeks. Before inserting the
catheter, a Bishop score was determined (18). At commencement of IOL all the women had unfavorable cervical scores (Bishop score 6). The catheter was introduced
into the endocervix and towards the space between the
amniotic membrane and the lower uterine segment. The
balloon reservoir was inflated with 4050 mL of saline
and retracted so that it rested on the internal os. Light
traction was applied and the catheter was taped on to the
inner aspect of the thigh. Fetal monitoring for a minimum of 20 min was continued. After spontaneous expulsion of the balloon, amniotomy was performed if the
Bishop score was 6. If spontaneous expulsion of the Foley catheter did not occur within 24 h, the balloon was
removed. If the cervix remained unripe with a Bishop
score <6 after balloon expulsion or removal, induction
was continued with intravaginal misoprostol. These
(n = 33) the woman was excluded from the final analysis
(Figure 1). Amniotomy was performed immediately after
expulsion or at the latest, after overnight rest on the next
morning depending on delivery unit capacity. Oxytocin
augmentation was started in the absence of spontaneous
contractions. The timing of oxytocin augmentation was at
the discretion of the obstetrician and varied between 2
and 24 h. The beginning of regular contractions was
defined from the start of contractions occurring at least
every 35 min after cervical dilation of 34 cm.
Data on delivery and neonatal outcomes were collected
from the hospital records. The outcomes included the
mode of delivery, oxytocin administration, postpartum
hemorrhage, maternal and neonatal infections, umbilical
artery blood gas values, Apgar scores, and admissions to
neonatal unit or neonatal intensive care unit (NICU).
When there was more than one indication for cesarean
delivery, the primary indication was categorized using the
following hierarchy: fetal distress, infection, failure to
progress and failed induction. Data on the study population characteristics and maternal antenatal risk factors,
such as maternal age, body mass index in early pregnancy, use of in vitro fertilization, parity, Bishop score,
smoking and gestational diabetes were collected from the
antenatal clinic charts. Obesity was defined as body mass
index 30 kg/m. Gestational diabetes was diagnosed by
an oral glucose tolerance test. All women with gestational
diabetes had normoglycemia and normal fetal growth
while on dietary care.
Streptococcus agalactiae of group B (GBS) was tested
for by culture from a vaginal and perianal specimen collected at a prenatal visit 4 weeks prior to delivery, or on
admission, using a risk-based strategy for GBS screening.

610

H. Kruit et al.

Maternal infections were categorized as intrapartum or

postpartum (from delivery to discharge). The criteria for
intrapartum infection were maternal fever (38C), fetal
tachycardia (160 bpm), uterine tenderness, purulent
amniotic fluid or vaginal discharge, and a total white cell
count >20 9 109/L. At least two of these criteria had to
be met, combined with administration of antibiotics.
Postpartum infection diagnoses included endometritis (by
the above criteria), wound infection, mastitis, urinary
tract infection and puerperal fever of unknown origin.
Neonatal infections were categorized into blood culture
positive sepsis, clinical sepsis, and suspected sepsis. Neonatal clinical sepsis was defined as a blood culture negative infection with symptoms and signs consistent with
sepsis (such as respiratory distress, apnea, tachycardia,
poor capillary perfusion, low blood pressure, fever, hypoor hyperglycemia, irritability, feeding problems, lethargy
and convulsions), abnormal blood values (such as elevated levels of the C-reactive protein, leukocytosis or leukopenia,
increased
neutrophil
precursors
and
thrombocytopenia) and positive response to a minimum
of 5 days of antibiotic treatment. The cases defined as
suspected sepsis had to have at least one symptom and
one abnormal laboratory test value, and a positive
response to antibiotic treatment.
All calculations were carried out using the Microsoft
Statistical Package for Social Sciences for Windows v18.0
(SPSS Inc., Chicago, IL, USA). Categorical variables were
compared by the chi-squared and Fishers exact tests when
appropriate. Data with continuous variables were analyzed
by the t-test when the data followed normal distribution
and by a MannWhitney U-test if this was not the case.
We used univariate logistic regression to estimate relative
risks represented by odds ratios with 95% confidence
intervals. A p-value < 0.05 was considered significant.

Results
The characteristics of the study population are shown in
Table 1. The women with induced labor were more often
nulliparous (p < 0.001) and more often had an extended
gestational age of 42 weeks at the start of IOL
(p < 0.001) compared with women with spontaneous
labor onset at or after 41+5 weeks. The medians of gestational weeks at the start of IOL and spontaneous labor
were, however, similar in both groups: 41.9 (range 41.7
42.3) and 41.9 (range 41.742.6).
Maternal outcomes are shown in Table 2. The nulliparous, but not parous, women with IOL more often
received prophylactic antibiotics and epidural or spinal
analgesia than women with spontaneous labor onset did
(p < 0.001, p = 0.03, respectively). Oxytocin augmentation was more common in IOL cases than among women

2015 Nordic Federation of Societies of Obstetrics and Gynecology, Acta Obstetricia et Gynecologica Scandinavica 94 (2015) 608614

H. Kruit et al.

Labor induction in prolonged pregnancy

Table 1. Characteristics of the study population.

Maternal age 35 years

Nulliparous
IVF
Smoking
BMI (kg/m)a 30 kg/m
Gestational diabetes
Gestational age 42 weeks

Foley catheter induction

(n = 303)

Spontaneous labor
(n = 250)

p-value

65
244
7
42
34
27
197

21.5
80.5
2.3
13.9
11.2
8.9
65.0

70
126
2
35
22
22
65

28.0
50.4
0.8
14.0
8.8
8.8
26.0

0.07
<0.001
0.19
0.96
0.28
0.96
<0.001

Chi-squared test or Fishers exact probability test.

BMI, body mass index; IVF, in vitro fertilization.
a
One missing value (spontaneous labor).
Table 2. Maternal outcomes.
Primiparous

Prophylactic antibiotic
Oxytocin augmentation
Epidural/spinal analgesia
Bishop score 3 at 41+5 gestational weeksa
Bishop score 3 at start of labor inductionb
Mode of delivery
Vaginal
Vacuum extraction
Cesarean section
Indication for cesarean section
Fetal distress
Infection
Labor arrest
Failed induction
Post partum haemorrhage 1000 ml
Vaginal delivery
Cesarean delivery
Fever 38C during labor
Suspected intrapartum infection
Postpartum infection
Endometritis
Wound infection
Fever of unknown origin

Multiparous

Foley
catheter
induction
(n = 244)

Spontaneous
labor
(n = 126)

146
233
216
119
112

59.8
95.5
88.5
50.4
47.3

33
112
120
20

26.2
88.9
95.2
23.5

153
45
91

62.7
18.4
37.3

115
30
11

91.3
23.8
8.7

38
7
27
19

41.8
7.7
29.7
20.9

6
0
5
0

54.5

21
33
12
15
9
6
2
1

13.7
36.3
4.9
6.1
3.7
2.4
0.8
0.4

13
3
2
3
2
0
2
0

Foley
catheter
induction
(n = 59)

Spontaneous
labor
(n = 124)

p-value

<0.001
0.02
0.03
<0.001

9
51
48
29
24

15.3
86.4
81.4
50.9
41.4

8
60
90
18

6.5
48.4
72.6
20.5

57
4
2

96.6
6.8
3.4

123
3
1

99.2
2.4
0.8

p-value

<0.001
0.55

0.20

45.5

0.42
0.34
0.29

0
0
2
0

11.3
27.3
1.6
2.4
1.6

0.56
0.93
0.11
0.13
0.26

4
1
1
1
1
0
1
0

1.6

0.06
<0.001
0.2
<0.001

100

7.0
50
1.7
1.7
1.7
1.7

0
1
0
0
10
0
2
1
0
0
0
0

0.21

100

8.1

0.80

1.6
0.8

Chi-squared test or Fishers exact probability test.

Missing values 10 (induction) and 77 (spontaneous labor).
b
Seven missing values.
a

with spontaneous labor, among both nulliparous and parous women (p < 0.001 and p < 0.02, respectively).
The overall cesarean delivery rate was 30.7% (n = 93)
in women with IOL and 4.8% (n = 12) among women
with spontaneous labor (p < 0.001). Differences in the

cesarean delivery rates were observed in nulliparous

women (37.3 vs. 8.7%, p < 0.001) but not among the
parous women (3.4 vs. 0.8%, p = 0.2). The odds ratio for
cesarean delivery among nulliparous women was 6.2
[95% confidence interval (CI) 3.212.1]. The indications

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Labor induction in prolonged pregnancy

H. Kruit et al.

Table 3. Neonatal outcomes.

Primiparous

Male
Birthweight, g [mean (SD)]
Macrosomia (>4500 g)
Apgar 1 min <7
Apgar 5 min <7
Umbilical artery pH <7.05a
Umbilical artery BE 12.0a
Neonatal infection
Suspected sepsis
Clinical sepsis
Infection of unknown origin
Admission to NICU
Admission to neonatal ward

Multiparous

Foley catheter
induction
(n = 244)

Spontaneous
labor (n = 126)

135
3701
8
22
8
5
7
19
13
5
1
30
7

55.3
(428)
3.3
9.0
3.3
2.1
3.0
7.8
68.4
26.3
5.2
12.3
2.9

69
3765
4
9
1
5
6
3
2
1
0
12
2

54.8
(352)
3.2
7.1
0.8
4.0
4.8
2.4
66.7
33.3

0.92
0.45
0.96
0.50
0.23
0.32
0.40
0.04

9.5
1.6

0.45
0.43

p-value

Foley catheter
induction
(n = 244)

Spontaneous
labor (n = 126)

23
3765
3
3
0
3
1
2
2
0
0
0
2

39.0
(352)
5.1
5.1

64
3871
9
5
1
1
1
2
1
1
0
1
5

51.6
(431)
7.3
4.0
0.8
0.8
0.8
1.6
50
50

0.11
0.12
0.58
0.75
0.53
0.09
0.52
0.60

0.8
4.0

0.49
0.83

5.5
1.8
3.4
100

3.4

p-value

Chi-squared test, Fishers exact probability test or t-test.

BE, base excess; NICU, neonatal intensive care unit.
a
Eleven missing values (primiparous).

for cesarean delivery did not differ between the groups of

nulliparous women. No difference was found in the rates
of postpartum hemorrhage between the groups of nulliparous or parous women (Table 2).
The Bishop score was 3 in 50.4% (n = 119) in the
nulliparous women and in 23.5% (n = 20) in women
with spontaneous labor (p < 0.001). The corresponding
figures among parous women were 50.9% (n = 29) and
20.5% (n = 18) (p < 0.001).
Of the nulliparous women who had a Bishop score 3
at IOL, 43.8% (49/112) had a cesarean delivery compared
with 31.2% of those with a Bishop score 4 (39/125)
(p = 0.04). Of parous women with a Bishop score 3,
only two of 24 had cesarean delivery, whereas all parous
women with a higher score delivered vaginally. The rate
of cesarean delivery following IOL of labor did not differ
between obese and women with normal weight (38.2 vs.
29.7%, p = 0.31). There were no differences in the overall
intrapartum or postpartum infection rates between
women with IOL and women with spontaneous labor
onset. However, postpartum endometritis occurred only
following IOL (Table 2). No cases of blood culture-positive maternal sepsis were found. Of the nulliparous
women with intrapartum infection, 66.7% (10/15) of the
induced and 33.3% (1/3) of the spontaneous labor group
had had a cesarean delivery.
No differences were found in the adverse neonatal outcomes (low Apgar score, low umbilical artery pH or low
base excess value), NICU or neonatal unit admissions

612

between the induced and spontaneous labor groups

(Table 3). There were more neonatal infections diagnosed
after IOL than after spontaneous labor. After excluding
cases of suspected neonatal sepsis and comparing only
clinical neonatal sepsis cases, there was no difference
between the two groups (p = 0.43). No blood culturepositive cases were found. Of neonatal infections among
nulliparous women, 6/19 followed vaginal delivery and 13
(68.4%) cesarean delivery. All parous women whose neonate was diagnosed with infection (n = 4) had delivered
vaginally. Overall, GBS was tested on only 11.2%
(n = 62) of the women.
Of the 33 women (9.8%) with a Bishop score <6 after
Foley catheter and continued induction with misoprostol,
29 (87.9%) were nulliparous and had a cesarean section
rate of 51.7% (15/29) if nulliparous, whereas 25% of parous women required section.

Discussion
Our results indicate that IOL for prolonged pregnancy is
as safe when a Foley catheter is used as when awaiting
onset of spontaneous labor during a 4-day period extending just past 42 weeks. However, this is associated with a
high cesarean delivery rate among nulliparas. IOL did not
seem to increase maternal or neonatal infections and neonatal outcomes were similar following induced and spontaneous labor. Nonetheless, there are major limitations
with regard to conclusions in a retrospective study affected

2015 Nordic Federation of Societies of Obstetrics and Gynecology, Acta Obstetricia et Gynecologica Scandinavica 94 (2015) 608614

H. Kruit et al.

by a selection bias whereby more women with post-term

pregnancy ended up in the induction group and where
there was skewness towards a higher proportion of nulliparous women in group induced by Foley catheter. Large
randomized controlled trials on post-term pregnancy
management have been published (19) but we focused on
a narrow time frame (gestational length 41+5 to
42+1 weeks). The value of this study lies in the use of that
approach, which offsets to some extent our lack of power.
Alexander et al. (20) have demonstrated a 40% increase
in the cesarean delivery rate (from 14 to 19%) following
IOL compared with spontaneous labor at 41 weeks.
Overall, for induction at term, cesarean delivery rates
seem to increase three- to eightfold regardless of whether
induction is mechanical or pharmacological (21,22). In
our study the rate was sixfold higher among nulliparous
women. This is of concern given the overall 14% cesarean
rate among women aiming for vaginal delivery in our
hospital during 2012. However, some recent studies have
shown that the risk of cesarean delivery in prolonged and
post-term gestations may be lower among women with
induced labor compared with those managed expectantly
(8,12,13). The reasons for the different results are not
known but could depend on the induction method used
and the definition of prolonged pregnancy.
Nulliparity and obesity increase the risk for prolongation
of pregnancy, but they are also independent risk factors for
cesarean delivery after induced labor (20,2325). Low
Bishop scores are associated with high rates of induction
failure and operative delivery (11,26,27), also seen in our
study. The cesarean delivery rate was even higher, almost
50%, among the women in whom there was sequential use
of the Foley catheter and intravaginal misoprostol.
Cervical ripening was assessed using the Bishop score,
which was originally derived from parous women (18).
We used a score of 6 as a cut-off for the use of amniotomy and oxytocin augmentation. A more modern concept would be a Bishop score 8 (28). The exact
mechanism of cervical ripening is not completely understood. Studies have proposed that it relates to a reduction
in collagen density coupled to remodeling of the collagen
fibers (29). A recent study suggests that cell-free fetal
DNA initiates an inflammation process and with that cervical ripening, leading to onset of labor (30). What happens with the use of a Foley catheter is not known.
The most common cesarean delivery indication following IOL was failure to progress (failed induction and
labor arrest), as also noted previously (15,27,31).
In previous studies, as shown in a recent Cochrane
review, IOL by means of Foley catheter has not been
associated with increased rates of maternal infection
(15,16,32), as also found in this study, but contrasting
results have also been described (33). Likewise, clinical

Labor induction in prolonged pregnancy

neonatal infectious morbidity was not more common following induced labor, as shown previously (15). IOL itself
has, however, been linked to increased admissions to neonatal unit (34).
Our key finding was the high rate of cesarean delivery
among nulliparous women undergoing IOL by Foley
catheter between 41+5 and 42+1 weeks of gestation. Given
the major impact that the first cesarean delivery has on
subsequent pregnancies, there is a need to optimize labor
induction among nulliparous women.

Funding
This study was supported by a grant from the Finnish
Medical Society Duodecim and Helsinki University Central Hospital Research Funds.
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2015 Nordic Federation of Societies of Obstetrics and Gynecology, Acta Obstetricia et Gynecologica Scandinavica 94 (2015) 608614