Keywords intrauterine device - cesarean section - postplacental intrauterine device insertion
- prenatal contraception counseling - intrauterine device continuation
Palavras-chave dispositivo intrauterino - cesárea - inserção de dispositivo intrauterino pós-dequitação
- aconselhamento contraceptivo pré-natal - continuidade do dispositivo intrauterino
Introduction
Intrauterine device (IUD) is an effective contraceptive method for postpartum period,
with the advantages over hormonal methods of being independent of women's compliance
and not affecting the coagulation system or lactation.[1 ]
Intrauterine device placement is usually performed 6 weeks following delivery (interval
insertion), due to evidence indicating a lower expulsion rate when compared with immediate
postplacental insertion.[2 ] However, in real life setting, women experience difficulties to return for a postpartum
visit, and it was reported that almost half of the women who had the intention of
using IUD for postpartum contraception turned out not to have an IUD inserted.[3 ] In face of these limitations of interval IUD placement, there has been growing interest
on immediate insertion. Immediate insertion is associated with an overall low expulsion
rate, of around 10%,[4 ] which is significantly lower when following cesarean when compared with vaginal
delivery.[4 ]
[5 ]
[6 ]
Brazil has an estimated population of over 200 million inhabitants and is among the
countries with the highest cesarean delivery rate.[7 ] Despite most women having access to prenatal care in Brazil,[8 ] postpartum contraception is not discussed frequently,[9 ] and health care providers view the moment of delivery as an inadequate setting to
provide information about IUD and for women to decide whether they want it to be inserted
or not.
In Brazil, almost two thirds of the women admitted to delivery are aged under 29 years
old.[10 ] Moreover, cesarean delivery rates are around 56%, and there is an established practice
of avoiding vaginal delivery in women with 2 or more previous cesarean sections. It
is, therefore, possible that offering postplacental IUD insertion to women who are
going to have a cesarean delivery, regardless of whether or not they received prenatal
contraception counseling, would be an effective strategy to avoid repeated cesarean
sections in young women.
The primary objective of this study was to determine the rates of IUD continuation,
uterine perforation and endometritis after 6 weeks and 6 months in women for whom
IUD contraception was offered at admission for delivery, immediately after the indication
of a cesarean section, and inserted after placental delivery. The secondary objective
was to estimate the proportion of women for whom the above mentioned strategy of immediate
IUD insertion potentially avoided a third or fourth cesarean section.
Methods
This was a prospective cohort study conducted between February 2012 and June 2013,
at the Hospital Universitário de Brasília, DF, Brazil. It was approved by the Ethics
Committee (register number 183/11) of the institution and conducted according to the
Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines
for cohort studies. Pregnant women aged 18 years or over for whom cesarean delivery
was indicated after admission were included when both the woman and the medical staff
on duty agreed to participate. The exclusion criteria were as follows: women with
a personal history of dysmenorrhea or menorrhagia, with a high risk of sexually transmitted
disease (arbitrarily defined as more than one sex partner over the last 6 months or
over the period of 6 months preceding pregnancy, or a positive human immunodeficiency
virus, venereal disease research laboratory or hepatitis B virus antigen test during
pregnancy), gestational age of less than 32 weeks at the time of delivery, fever over
the last 48 hours, membrane rupture for over 12 hours before delivery and signs of
vaginitis or cervicitis on gynecological examination.
Immediately after indication of cesarean section, the women were offered the possibility
of IUD insertion during surgery, and all their doubts about this contraception method
were clarified. Those who agreed with insertion signed a written informed consent.
Following placental delivery, the IUD (model TCu 380A, Injeflex, São Paulo, SP, Brazil)
was inserted using a standard technique: while one of the surgeon's hand held the
outer face of the fundus of the uterus, the other hand, with the IUD between the second
and third fingers, inserted the device in the fundus through the hysterotomy incision
and, after this, directed the strings to the cervix, without cutting them. The IUD
was inserted by the medical residents or staff on duty, who had received a brief training
provided by the researchers. All participants received one to two grams of cefazolin
prophylaxis before cesarean section.
To avoid follow-up losses, all participants received a phone number to contact the
researchers over the following 6 months, if necessary. The women returned for postpartum
visits with the researchers after 6 weeks and 6 months and underwent gynecological
examination and transvaginal sonography at the Hospital Universitário de Brasília.
For women who had not undergone oncologic colpocytology assessment during pregnancy,
this was done in the 6-week visit. When the participant missed one of the postpartum
visits and phone contact was unsuccessful, the researchers visited the women in her
residency to make the visit to the hospital feasible.
The IUD was considered adequately positioned at the 6-week and 6-month visits if it
was inside the uterine cavity, above the internal cervical os. Expulsion was defined
as total exteriorization of the IUD or when transvaginal sonography showed the device
was inside the cervical canal. In the latter situation, the IUD was immediately extracted.
Intrauterine device removal was defined by removal of the device, due to any reason,
when it was situated above the internal cervical orifice. Statistical analysis was
conducted using Graphpad Prism software, version 7.0 (GraphPad Software Inc., La Jolla,
CA, USA). The Chi-squared and Fisher exact tests were used to compare proportions,
and one-way analysis of variance (ANOVA) was used to compare means. Statistical significance
was considered when the p -value was lower than 0.05.
Results
One hundred women were included in the study, and their characteristics are presented
in [table 1 ]. The mean age of the participants was 27.7 (±5.6) years (95% confidence interval
26.6–28.7 years). Two thirds of the participants had at least a previous cesarean
section, and one in every five participants had two or more previous cesarean sections
([Table 1 ]).
Table 1
Characteristics of the women included in the study (n = 100)
Variables
N (%)
Age (years)
< 25
33 (33)
25-34
52 (52)
≥ 35
15 (15)
Previous deliveries
None
21 (21)
1 or more
79 (79)
Previous cesarean sections
None
33 (33)
1
45 (45)
2 or more
22 (22)
Gestational age at delivery (weeks)
< 37
5 (5)
37-40 + 6
77 (77)
41 or more
18 (18)
Among the 100 participants, 99 returned for the 6-week visit ([Fig. 1 ]). Five of them (5.1%) presented IUD expulsion, and one underwent IUD removal due
to endometritis. Two women requested IUD removal at this visit due to excessive bleeding,
and one requested removal after being informed that the device was rotated to the
transversal position (i.e. the main axis of the IUD was perpendicular to the main
uterine axis), despite being asymptomatic. Therefore, 90 (90.9%) women remained with
the IUD after 6 weeks of insertion during cesarean delivery ([Fig. 1 ]).
Fig. 1 Six-month follow-up of 100 participants for whom IUD insertion was offered immediately
after the indication of a cesarean section and inserted after placental delivery.
A total of 88 women returned for the 6-month visit, and 3 (3.4%) of them had IUD expulsion.
One woman presented endometritis between the 6-week and 6-month visits and was treated
with antibiotics without IUD removal, with good response. Two women requested IUD
removal at this visit because of excessive bleeding, and two requested removal after
being informed that the device was rotated to the transversal position, despite being
asymptomatic. Therefore, 81 (83.5%) of the participants remained with the IUD after
6 months ([Fig. 1 ]). Among these women, the strings were visible during gynecological assessment in
31 (38.3%).
The expulsion/removal rate during the first 6 weeks after insertion (9.1%) was similar
to that observed between 6 weeks and 6 months of insertion (9%, p > 0.05). When only women presenting expulsion were considered, there was also no
difference between both time points (5.1% at the 6-week visit vs. 3.4% at the 6-month
visit, p > 0.05). Among the 97 women who completed follow-up, 81 (83.5%) remained with the
IUD 6 months after cesarean delivery, 8 (8.2%) presented expulsion, and 8 (8.2%) requested
its removal. There were no cases of uterine perforation. There was no difference between
women who remained with the IUD at 6 months and women with IUD expulsion/removal with
respect to age, parity, the number of previous cesarean deliveries or gestational
age at delivery ([Table 2 ]).
Table 2
Comparision between the women who remained with de intrauterine device after a six-month
follow-up and those who presented expulsion/removal
Variables
With IUD (n = 81)
Without IUD (n = 16)
P -value
Age (mean ± SD)
29.1 ± 6.3
27.5 ± 5.5
p = 0.322[a ]
Age (years)
< 25
27 (32.9%)
5 (33.3%)
p = 0.3187[b ]
25–34
43 (52.4%)
7 (46.7%)
≥ 35
12 (14.6%)
3 (20.0%)
Previous deliveries
None
16 (19.5%)
5 (33.3%)
p = 0.3046[c ]
1 or more
66 (80.5%)
10 (66.7%)
Previous cesarean sections
None
25 (30.5%)
7 (46.7%)
p = 0.2193[b ]
1
36 (43.9%)
7 (46.7%)
2 or more
21 (25.6%)
1 (6.6%)
Gestational age at delivery (weeks)
< 37
4 (4.9%)
1 (6.7%)
p = 0.8723[b ]
37–40 + 6
63 (76.8%)
12 (80%)
41 or more
15 (18.3%)
2 (13.4%)
Abbreviations: IUD, intrauterine device, SD, standard deviation.
a Student t -test;
b Chi-square test;
c Fisher exact test.
Among the 81 women who remained with the IUD 6 months following the delivery, 25 (30.8%)
had undergone only the cesarean section in which the device was inserted, 36 (44.4%)
had undergone 2 cesarean sections, 18 (22.2%) had undergone 3 cesarean sections, and
2 (2.5%) had undergone 4 cesarean sections. Therefore, taking into account that offering
vaginal delivery for women who have undergone 2 or more previous cesarean sections
is exceptional in Brazil, IUD insertion hypothetically prevented the 3rd , 4th and 5th cesarean sections in 36, 18 and 2 of the participants, respectively. There was no
statistically significant difference among women who had undergone one, two, three
or more cesarean sections with respect to age ([Fig. 2 ]).
Fig. 2 Age distribution of women with one, two, or three or more cesarean sections. The
mean ± SD was 25.4 (±5.6), 28.2 (±5.5) and 28.9 (±4.7) years, respectively (p > 0.05 by one-way analysis of variance).
Fig. 3 Suggested approach for offering postpartum contraception. IUD: Intrauterine device.
Discussion
In the present study, we found that offering IUD contraception immediately before
cesarean delivery, followed by device insertion during surgery, was an effective strategy,
since after 6 weeks the rate of IUD permanence was 90%. This strategy is also possibly
more convenient, because women who wish to use IUD contraception do not need to return
early in the postpartum, a period with well-known difficulties.[3 ] Moreover, the fact that there was no difference in the expulsion rate during the
first 6 weeks and in the period between 6 weeks and 6 months reinforces the convenience
of IUD insertion during surgery, when the uterus is literally “in the hand and open”,
and the procedure can be carried out without any additional expense.
Three previous studies, 2 conducted in Brazil and the other in North America, reported
a 100% rate of IUD continuation 6 months after insertion during cesarean section.[6 ]
[11 ]
[12 ] However, 2 studies assessed a limited number of women (19 and 25),[6 ]
[11 ] and in the other one, 52% of the 90 women included were lost to follow-up.[12 ] Since the rate of IUD expulsion is overall low, it is expected that small samples
comprise more frequently women in whom the IUD remained in the uterus. In addition,
large losses to follow-up may impair data interpretation, because it is not possible
to conclude that the women who did not return for follow-up were those more often
presenting IUD expulsion. These aspects may explain the differences between the findings
from previous studies[6 ]
[11 ]
[12 ] and our data. We assessed 100 women and had a low rate of loss to follow-up (3%).
Intrauterine device permanence rates after 6 weeks (90%) and 6 months (81%) were similar
to those reported by Çelen et al (93% and 82%, respectively), who assessed 245 women
and had no losses to follow-up.[13 ]
Levi et al[14 ] recently reported an 83% IUD continuation rate after 6 months among women randomly
assigned for IUD insertion during cesarean section. Despite the similarity with our
finding, the studies have methodological differences. In particular, Levi et al[14 ] inserted another IUD in the 3 participants presenting expulsion and in the participant
from whom the initial device was removed due to endometritis, and these 4 women were
considered as cases of IUD permanence at 6 months. In the current study, we reported
the continuation rate of IUD exclusively inserted during the cesarean section, and
it could be expected that if the expulsed or removed IUDs had been replaced the rate
at 6 months would have been higher. It is important to point that from a public health
perspective, immediate IUD replacement after expulsion or removal could be an interesting
strategy for increasing the continuation rate in women who had the IUD inserted during
cesarean delivery.
Another approach to increase the continuation rate would be to avoid unnecessary removal
of IUDs inserted during cesarean sections. Two participants (2.1%) included in our
study presented endometritis, one of them underwent IUD removal, and the other one
maintained the IUD and showed a good response to antibiotic treatment. There are currently
no data to provide definitive recommendations for or against IUD maintenance in women
with endometritis, and, therefore, the best approach for treating these women is based
on clinical judgement. The Center for Diseases Control and Prevention from North America
recommends that women outside the puerperium with inflammatory pelvic disease receiving
IUD contraception should be treated with antibiotics, and the device should be removed
only if there is no satisfactory response to therapy after 48to 72h.[15 ] We believe that this recommendation could be extended to women with endometritis
following cesarean delivery, since this approach would enable the assistant physician
to determine, on an individual basis, those women for whom antibiotic therapy should
be best accompanied by IUD removal.
An unexpected finding in our study was that eight women exhibited IUD rotation to
a transversal situation inside the endometrial cavity in sonographic assessment. According
to criteria established in the study design, they were considered to be well positioned,
but, on the basis of radiologic criteria, rotated devices are considered malpositioned
due to displacement.[16 ] This finding was informed to all eight participants, and three of them decided to
remove the IUD despite being asymptomatic. To our knowledge, this situation was not
reported in previous studies. Outside the puerperium, IUD rotation is associated with
pain and bleeding,[16 ] and, in the current study, two participants exhibiting IUD rotation requested its
removal due to bleeding. We, therefore, suggest that women showing IUD rotation and
presenting bleeding or feeling unsafe should undergo prompt IUD replacement.
We did not observe any case of uterine perforation, a complication that was also not
reported in a study involving over 17,000 women undergoing IUD insertion during cesarean
section in 6 different countries.[5 ]
Six months after insertion, IUD strings were visible in 38% of the participants with
well-positioned device. In this same time period and using the same IUD model, data
from other studies indicated visible strings in between 40[14 ] and 78% of the participants.[17 ] Both women and health care providers should acknowledge that the strings may not
be visible in appropriately positioned IUDs that were inserted during cesarean delivery.
By offering IUD insertion to women who had received no prenatal contraception counseling,
we challenged a common dogma in Brazil: that the time point immediately before cesarean
delivery is an inadequate moment for the women to receive counseling and freely decide
about IUD insertion. Data from Brazilian studies indicate that most women do not receive
prenatal contraception counseling.[9 ] Among those who do, after delivery, only one third has access to the contraceptive
method that was chosen, with contraceptive injection being the method showing higher
concordance between the women's previous choice and the method used in the puerperium,
and IUD showing the lowest concordance in this respect.[18 ] Although we believe that contraception counseling should be routinely provided in
prenatal care because this is the most effective postpartum contraception strategy,[5 ]
[19 ] we acknowledge that not offering IUD insertion at the moment of delivery only because
the method was not discussed during the pregnancy represents, indeed, a “second failure”
in providing appropriate contraception counseling.
The current study sought solutions for a common problem in public Brazilian maternities.
Since Brazil is the second country with the higher cesarean section rate worldwide,[7 ] with a population of young parturients, and a law system that restricts surgical
sterilization during cesarean delivery, it is common that pregnant women younger than
30 years old have a previous history of one or more cesarean deliveries. Additionally,
because vaginal delivery is exceptionally offered for women who have undergone two
or more cesarean sections, thousands of young women are annually exposed to the risks
of repeated cesarean sections. In the current study, we strongly believe that the
cases in which the IUDs remained in the endometrial cavity after 6 months of insertion
potentially prevented an additional cesarean section in two thirds or the participants,
since 68% of women were undergoing the 2nd , 3rd or even 4th cesarean delivery at the moment of IUD insertion.
Women undergoing repeated cesarean sections are at increased risk of bowel and urinary
tract injury, but the most feared complication is placenta accreta,[20 ] which is associated with high morbidity and mortality. Due to the dramatic increase
in the frequency of placenta accreta in the United States over the last two decades,
the implementation of centers of excellence for managing this condition was recently
proposed.[21 ] Despite the reduction in morbidity and mortality when women with established placental
accretism are managed in these high complexity centers (tertiary prevention), providing
effective contraception would be an effective mean to promote primary prevention of
this condition.
It is important to point that, in the present study, there was a great effort to avoid
losses to follow-up, particularly at the 6-week visit. This is a time period when
women face difficulties in returning to the health service. Assessment at this time
may, therefore, not reflect the real-life setting, and therefore reinforces the importance
of assuring that the contraceptive method desired by the woman is provided at discharge.
Our findings are limited by the fact that the participants were recruited from only
one center. However, the high rates of cesarean deliveries are evenly distributed
in the country, and one may, therefore, speculate that the results of offering IUD
insertion at the moment of the indication of cesarean section would be similar among
Brazilian public maternities.
In light of our findings, we strongly believe that health care providers should not
view the lack of antenatal contraception counseling as a barrier to offering IUD insertion
at the time point of cesarean section indication. This approach not only enables women
to enjoy their sexual and reproductive rights but potentially discontinues a myriad
of health injuries. We hence propose a strategy to optimize contraception in the postpartum
period in [Figure 3 ].
Conclusion
Our findings indicate a high rate of IUD continuation and low rates of complications
after postplacental insertion for women undergoing cesarean sections in a setting
of high cesarean delivery rates and deficient prenatal contraception counseling. Since
offering trial of labor is unusual after two or more previous cesareans, it is possible
that offering IUD after admission for delivery may reduce the risk of repeated cesarean
sections and its inherent risks.