Timing of Copper Intrauterine Device

Insertion After Medical Abortion

A Randomized Controlled Trial
Noaa Shimoni, MD, MPH, Anne Davis,
and Carolyn Westhoff, MD, MSc

MD, MPH,

Maria Elena Ramos,

MA,

Linette Rosario,

MD,

OBJECTIVE: To compare intrauterine device (IUD) use at

6 months in women randomized to receive an intrauterine copper contraceptive 1 week compared with 1 month
after medical abortion.

and delayed groups reported a median of 20 and 19

bleeding or spotting days, respectively (P.15). We detected no cases of serious infection, uterine perforation,
or hemorrhage.

METHODS: We recruited women undergoing medical

abortion with mifepristone and misoprostol and choosing the copper IUD for contraception. We randomly
assigned participants to immediate insertion 1 week
after mifepristone or delayed insertion 4 6 weeks
later. We followed rates of IUD insertion, 6-month utilization, expulsion, removal, and pregnancy. Participants
recorded bleeding in a diary for 4 weeks.

CONCLUSION: Immediate insertion increased uptake of

the IUD without increasing expulsions or bleeding.

RESULTS: We randomized 156 participants. We inserted

an IUD in 97% of participants in the immediate group and
76% in the delayed group (P<.001). At 6 months, 69% of
participants in the immediate group used the IUD compared with 60% in the delayed group (P.24). Expulsion
rates were comparable; 12% (8 of 69) in the immediate
group compared with 11% (7 of 65) in the delayed group.
Removals occurred in 14% (10 of 69) of immediate and
8% (5 of 65) of delayed group participants (P.21). Four
pregnancies occurred in delayed group participants who
did not return for IUD insertion (P.09). The immediate
From the Columbia University Department of Obstetrics and Gynecology and
New York Presbyterian Hospital, New York, New York.
Supported by an anonymous foundation. The CuT380A intrauterine copper
contraceptives were donated by DuraMed.
Presented as a poster at Reproductive Health 2010, September 2225, 2010,
Atlanta, Georgia.
Corresponding author: Noaa Shimoni, MD, MPH, 622 W. 168th Street, New
York, NY 10032; e-mail: ns2476@columbia.edu.
Financial Disclosure
Dr. Westoff received grant money that was paid to Columbia University from the
Department of Health and Human Services. She serves on the advisory board of
Duramed/Teva and is a member of Data Safety and Monitoring Boards for
Phase 4 safety studies sponsored by Merck and Bayer. She has received
investigator-initiated grants from Merck and Pfizer. The other authors did not
report any potential conflicts of interest.
2011 by The American College of Obstetricians and Gynecologists. Published
by Lippincott Williams & Wilkins.
ISSN: 0029-7844/11

VOL. 118, NO. 3, SEPTEMBER 2011

CLINICAL TRIAL REGISTRATION:

www.clinialtrials.gov, NCT00737178.

Clinicaltrials.gov,

(Obstet Gynecol 2011;118:6238)

DOI: 10.1097/AOG.0b013e31822ade67

LEVEL OF EVIDENCE: I

omen undergoing abortion are often at risk for

repeat pregnancy and are likely to benefit from
immediate initiation of highly effective contraceptive
methods such as the intrauterine device (IUD). Use of
IUDs has increased in the United States,1 and recent
studies demonstrate that women undergoing suction
abortion accept immediate IUD insertion when available.2,3 Intrauterine device perforation and expulsion
rates immediately after first trimester suction abortion
are low and comparable to interval insertion.3 6 A
recent observational study reported a low expulsion
rate of 4.1% when women received IUDs an average
of 8 days after medical abortion.7
Medical abortion now comprises 22% of all abortions under 9 weeks gestation in the United States.8
Insertion of an IUD on the day complete abortion is
confirmed may be ideal. Ovulation resumes as early
as 8 days after medical abortion,9 some couples
reinitiate sexual activity soon after the abortion is
complete,10 and many women cannot return for delayed insertion appointments. In one study (n53),
only 32% of women choosing the IUD as their
postabortion method received one by 6 months; the
others did not return because of time needed for an
additional visit.11 In a larger randomized trial of

OBSTETRICS & GYNECOLOGY

623

immediate compared with delayed IUD insertion

after first trimester suction abortion (n259), 106
women were assigned to delayed insertion; 42% of
these women (n43) never returned.12 Whether timing of IUD insertion immediately after medical abortion affects subsequent utilization, bleeding, or removal compared with delayed insertion remains
unknown.
The goal of our study was to compare immediate copper IUD insertion 1 week after medical
abortion to delayed copper IUD insertion 4 6
weeks later. We hypothesized that more women
offered immediate copper IUD insertion would undergo insertion and would be using the IUD at 6
months compared with those offered delayed insertion. We also sought to compare rates of expulsion,
removal, subsequent pregnancy, bleeding, and insertion pain in the immediate and delayed groups.

MATERIALS AND METHODS

This study was conducted at Columbia University Medical Center from July 2008 to October 2009 with approval from the local Institutional Review Board.
Healthy English-speaking or Spanish-speaking women
seeking medical abortion up to 63 days from the last
menstrual period were eligible to enroll if they desired
a copper IUD (ParaGard, DuraMed Pharmaceuticals,
Pomona, NY) for contraception for at least 6 months.
Additional inclusion criteria were a working telephone number and plans to be in the area for the next
6 months. We excluded women with contraindications to IUD use such as a documented cervical
gonorrhea or Chlamydia infection in the past 3
months, a known bleeding diathesis, serum hemoglobin less than 10 g/dL, or an untreated high-grade
squamous intraepithelial lesion.
All women undergoing medical abortion received routine contraceptive counseling and those
selecting the copper IUD were offered participation
in the study. All participants provided written informed research consent. We screened participants
for gonorrhea and Chlamydia infection unless screening results were negative in the past 3 months. The
investigator or research assistant enrolled participants
and administered a baseline questionnaire to obtain
demographic, contraceptive, and pregnancy history.
We specified gestational age based on transvaginal ultrasonography and first day of last menses. We
administered 200 mg of oral mifepristone in the office
and participants placed 800 micrograms of misoprostol in the buccal mucosa at home 24 to 48 hours later.
Supportive medicines included promethazine, ibuprofen, and acetaminophen with codeine. All partic-

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Shimoni et al

ipants received a prescription for doxycycline 100 mg

orally twice daily for 1 week as infection prophylaxis.
Each participant received a 4-week diary to note
bleeding, spotting, or cramping beginning with mifepristone administration.
Participants returned 1 week after mifepristone
administration per usual clinic protocol. Participants
who confirmed interest in the copper IUD were
sequentially randomized by the investigator or research assistant using opaque numbered envelopes to
either immediate or delayed insertion of the IUD in
an allocation ratio of 5:6, respectively. We decided to
randomize more women into the delayed group in
anticipation of greater loss to follow-up. After randomization, we performed a transvaginal ultrasound
examination to ascertain if the abortion was complete
(defined as absence of the gestational sac). Randomization occurred before ultrasound examination to
prevent selective exclusions based on ultrasound findings. Those randomized to the immediate group
underwent IUD insertion during the same visit; those
randomized to the delayed group received an appointment to return for insertion 4 6 weeks after
mifepristone administration. In cases of a retained sac
(without evidence of growth), we provided a repeat
dose of misoprostol or vacuum aspiration according to
patient preference. Continuing pregnancies were managed with vacuum aspiration. We also planned a priori
to defer insertion for endometrial stripes thicker than 3
cm. Participants requiring these further interventions
remained in the study and IUDs were inserted after the
abortions were complete.
Participants received 800 mg of ibuprofen before
insertion and we performed a transvaginal ultrasound
examination after insertion to document IUD location
in both groups. Insertion pain was rated on a 10-cm
visual analog scale twice: first before speculum insertion
(baseline) and then again after the IUD was inserted. Pain
in excess of baseline was attributed to IUD insertion.
We offered delayed group participants interim
contraception. If a participant did not return as scheduled, we contacted her and offered another insertion
appointment as soon as possible within the 6-month
study period.
We scheduled all participants for an IUD check 6
to 8 weeks after placement, which included a transvaginal sonogram. We defined expulsion as either
movement of the entire IUD into the vagina or
presence of any part of the IUD in the cervical canal
on physical or ultrasound examination. We removed
expelled IUDs and offered reinsertion.
We contacted participants 3 months after enrollment to ascertain contraceptive use. An exit interview

IUD Insertion Timing After Medical Abortion

OBSTETRICS & GYNECOLOGY

Enrolled
N=204

Randomized
n=156

Immediate insertion
n=71
IUD not placed: n=2
Declined IUD: 2

Excluded: n=48
Did not return for
randomization visit: 27
Chlamydia: 4
Anemia: 1
Declined IUD: 16

Delayed insertion
n=85
IUD not placed: n=20
Declined IUD: 16
Lost to follow-up: 4

IUD placed
n=69; 97%
Excluded after IUD placed: n=20
Lost to follow-up: 5
IUD removed: 10
IUD expelled, replaced, and
re-expelled: 2
IUD expelled and not
replaced: 3
IUD in place at 6 months*
n=49; 69%

IUD placed
n=65; 76%
Excluded after IUD placed: n=14
Lost to follow-up: 5
IUD removed: 5
IUD expelled, replaced, and
re-expelled: 1
IUD expelled and not
replaced: 3

VOL. 118, NO. 3, SEPTEMBER 2011

Shimoni. IUD Insertion Timing After

Medical Abortion. Obstet Gynecol
2011.

IUD in place at 6 months

n=51; 60%

was scheduled 6 months after enrollment; that visit

included a transvaginal sonogram and satisfaction
questionnaire. We conducted the exit interview by
telephone if participants could not return or were no
longer using the IUD. Participants received up to $60
for their participation. All visits occurred in the
outpatient setting. Study investigators were not
blinded to study arm.
We decided a priori that a 20% difference in IUD
utilization between the two groups at 6 months would
be clinically meaningful, and we assumed 70% of
participants in the delayed group and 90% in the
immediate group would be using the IUD at 6
months.1315 These two assumptions, together with
of 0.05 and 80% power, yielded a total sample size
needed of 142. We overenrolled to accommodate for
loss to follow-up. A staff member not involved with
enrollment used a random number table to generate
the allocation sequence. We performed statistical
analyses using Microsoft Access and SAS 9.2. We
compared categorical and continuous variables using 2, Fisher exact test, Student t test, or WilcoxonMann-Whitney U test, as appropriate. We used
intention-to-treat analysis for IUD utilization at 6
months and per-protocol analysis for expulsions
and removals. We fitted a logistic model to compare bleeding in the two groups. Missing bleeding
data were excluded.

Fig. 1. Randomization and follow-up

of study participants. Allocation into
the immediate and delayed groups
was performed in a ratio of 5:6. *The
49 women include 46 women whose
intrauterine devices (IUDs) remained
in place throughout the study, and
three women whose IUDs were expelled, replaced, and retained at 6
months. The 51 women include 48
women whose IUDs remained in
place throughout the study and three
women whose IUDs were expelled,
replaced, and retained at 6 months.

RESULTS
We enrolled 204 women. We excluded 48 participants for failure to return for the randomization visit
(n27), Chlamydia infection (n4), anemia (n1),
and change of decision (n16). We randomized 156
participants, 71 to immediate and 85 to delayed IUD
insertion (Fig. 1). Table 1 shows the two groups had
comparable baseline characteristics. Nine percent of
participants (n14) were lost to follow-up. Three
participants still using the IUD at 6 months completed
exit interviews by telephone.
Sixty-nine of 71 participants randomized to the
immediate group (97%) underwent IUD insertion
during the study. Two participants in the immediate
group declined IUD insertion after allocation. In
contrast, 65 of 85 randomized to the delayed group
(76%) underwent IUD insertion (P.001).
Use of IUDs was greater in the immediate group
but not statistically different; 69% (n49 of 71) of
immediate group participants compared with 60%
(n51 of 85) of delayed group participants were still
using the IUD at 6 months (P.24).
Of participants randomized to the immediate
group, 56 underwent IUD insertion within 8 days of
mifepristone administration, eight between days 9
and 14 of mifepristone administration, and five more
than 14 days after mifepristone administration. Two
immediate group participants delayed insertion be-

Shimoni et al

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625

Table 1. Baseline Demographics of Immediate

and Delayed Group Participants

Baseline characteristic
Age (y)
Gestational age (d)
Race or ethnicity
Non-Hispanic
Hispanic
Education
Less than high school
High school degree
Bachelor degree or more
Language spoken at home
English
Spanish
Both
Past pregnancy
No
Yes
Past birth
No
Yes
Past birth control used
No
Yes
Past IUD use
No
Yes

Delayed
(n85)

26.96.0
49.36.7

26.45.8
48.47.3

2 (3)
69 (97)

4 (5)
81 (95)

45 (63)
19 (27)
7 (10)

54 (64)
24 (28)
7 (8)

15 (21)
45 (63)
9 (13)

11 (13)
61 (72)
13 (15)

3 (4)
68 (96)

7 (8)
78 (92)

10 (14)
61 (86)

14 (16)
71 (84)

4 (6)
67 (94)

5 (6)
85 (94)

66 (93)
5 (7)

79 (93)
6 (7)

IUD, intrauterine device.

Data are meanstandard deviation or n (%).

yond 8 days for management of a retained sac; both

participants had the IUD placed at the time of a
suction aspiration. No other insertions were delayed
for ultrasound findings; other delays resulted from
late follow-up (n10) and deferred IUD insertion
(n1). In the delayed group, 60 participants had the
IUD inserted within 42 days, and five delayed insertion further. Four delayed group participants presented with retained sacs at follow-up. Management
occurred with misoprostol or aspiration.
Expulsion of the IUD was similar in the two
groups: 12% (n8) in the immediate and 11% (n7)
in the delayed group (P.88). Eight participants
elected to have another IUD inserted after expulsion,
four in each group. Of these reinsertions, two in the
immediate and one in the delayed group expelled the
IUD again. Three expulsions in the immediate group
and four in the delayed group were diagnosed by
sonogram only.
More IUD removals occurred in the immediate
group; however, this difference did not reach statistical significance. Ten participants (14%) in the immediate group and five participants (8%) in the delayed

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Shimoni et al

Proportion reporting bleeding or spotting

Immediate
(n71)

IUD inserted
(immediate)
Immediate insertion
Delayed insertion

1.0
0.9
0.8
0.7
0.6
0.5
0.4
0.3

IUD inserted
(delayed)

0.2
0.1
0.0
1

11 13 15 17 19 21 23 25 27

Days from medical abortion

Fig. 2. Bleeding patterns for days 128, starting with

mifepristone administration.
Shimoni. IUD Insertion Timing After Medical Abortion. Obstet
Gynecol 2011.

group requested removal during follow-up (P.21). In

both groups, the most commonly cited reasons for
removal were bleeding and pain. Removals occurred
throughout the study in both groups. Number of
bleeding days reported on the 28-day bleeding diary
did not predict removal; participants requesting removal reported a median of 17 days (range 10 27) of
bleeding or spotting, whereas those continuing to use
the IUD reported 20 days (range 6 28).
Four pregnancies occurred during the study, all in
participants randomized to delayed insertion who did
not return for IUD insertion, whereas no pregnancies
occurred in the immediate group (P.09). Two participants continued their pregnancies, one terminated,
and one had a spontaneous abortion.
Participants returned 105 bleeding diaries, 45
(63%) from immediate and 60 (71%) from delayed
group participants, all initiated on the day of mifepristone administration and continued for 28 days. Immediate group participants reported a median of 20
days (range 8 28) of bleeding or spotting during the
28 diary days; delayed group participants reported a
median of 19 days (range 6 28; P.15). Immediate
and delayed group participants reported cramping for
a median of 5 days (range 0 24) and 4 days (range
0 19) days, respectively (P.14).
Figure 2 compares the proportion of women
reporting bleeding or spotting in each group over
time. A logistic regression model did not find bleeding or spotting differences in the two groups (P.11).
Pain recorded on a visual analog scale during
IUD insertion increased a median of 10 mm (range
44 to 93) from baseline in the immediate group and
13 mm (range 43 to 80) in the delayed group

IUD Insertion Timing After Medical Abortion

OBSTETRICS & GYNECOLOGY

(P.30). There was no difference in pain before or

during insertion between the two groups (data not
shown).
We identified no cases of serious infection, uterine perforation, hemorrhage, or anemia requiring
IUD removal or transfusion. One IUD was inserted in
a participant before review of results identifying a
Chlamydia infection. She was treated and the IUD was
left in place. One ectopic pregnancy was identified,
treated successfully with methotrexate, and the IUD
was subsequently inserted. Both participants were
included in the analysis. One delayed group participant received a levonorgestrel intrauterine system.
She was included in the analysis.

DISCUSSION
This randomized trial examined timing of IUD insertion after medical abortion. Intrauterine copper contraceptive uptake was significantly greater in women
offered early insertion after medical abortion, with
97% receiving the IUD compared with 76% in the
delayed group. We attribute this high level of uptake
to easy IUD access incorporated into the medical
abortion follow-up visit.
More women randomized to immediate insertion
used the IUD at 6 months than those randomized to
the delayed group; however, this modest difference
did not reach statistical significance. Our study environment may have contributed to the smaller than
expected difference between the two groups. In this
study, we provided close follow-up, flexible and
prompt appointments, and free IUDs for participants.
This seamless access likely resulted in a higher rate of
insertion and use than would occur outside a research
setting, especially for women delaying IUD insertion.
Early IUD insertion did not increase expulsions,
which were similar in the two groups. Our expulsion
rate is higher than reported in recent studies of IUDs
inserted after suction abortion. When we exclude the
eight expulsions diagnosed by sonogram only, our
expulsion rate is similar to expulsion rates reported
elsewhere.3,16
The rate of IUD removal was greater among the
immediate group, although this difference did not
reach statistical significance. Bleeding and pain were
common reasons for removal in both groups and
removals occurred throughout the study in both
groups. The reason for this modest removal difference
is unclear.
The four pregnancies in the study occurred
among the 20 delayed group participants who did not
return for IUD insertion. This underscores the impor-

VOL. 118, NO. 3, SEPTEMBER 2011

tance of early initiation of effective contraception in

women after abortion.
Reported bleeding during the first 28 days after
mifepristone was similar in the two groups; early IUD
insertion did not increase the duration of bleeding.
Prolonged bleeding or spotting is common after medical abortion; one study reported an average of 24
days, which is consistent with our results.17 Emphasizing the possibility of prolonged bleeding after
medical abortion may improve IUD retention in
women selecting early placement. Clinicians should
be reassured that early insertion is safe and will not
significantly worsen bleeding or pain after medical
abortion.
Our study has limitations. We provided the intrauterine copper contraceptive to participants; thus, our
results may not be generalized to the levonorgestrel
intrauterine system. This study was designed to detect
a 20% difference in IUD use at 6 months. The
observed difference at 6 months was only 9% and was
not statistically significant. Differences in IUD insertion were substantial; however, both groups had less
IUD continuation than we expected. A larger study
may have demonstrated greater IUD utilization after
early insertion, as seen in a recent study of IUD
insertion after uterine aspiration.3 Our study did not
have sufficient power to detect differences in secondary outcomes. Because we only collected bleeding
diaries for 28 days, we cannot assess whether later
bleeding contributed to the removals requested by
women in both groups.
Our data support that offering IUD insertion at
the medical abortion follow-up visit results in more
IUD insertions and is not associated with adverse
outcomes such as expulsion or more bleeding. We
conclude immediate intrauterine copper contraceptive insertion after medical abortion should be offered
routinely to patients.
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