Timing of Copper Intrauterine DeviceInsertion After Medical AbortionA Randomized Controlled Trial

Noaa Shimoni, MD, MPH, Anne Davis, MD, MPH, Maria Elena Ramos, MA, Linette Rosario, MD,and Carolyn Westhoff, MD, MSc

OBJECTIVE: To compare intrauterine device (IUD) use at6 months in women randomized to receive an intrauter-ine copper contraceptive 1 week compared with 1 monthafter medical abortion.

METHODS: We recruited women undergoing medicalabortion with mifepristone and misoprostol and choos-ing the copper IUD for contraception. We randomlyassigned participants to immediate insertion 1 weekafter mifepristone or delayed insertion 46 weekslater. We followed rates of IUD insertion, 6-month utili-zation, expulsion, removal, and pregnancy. Participantsrecorded bleeding in a diary for 4 weeks.

RESULTS: We randomized 156 participants. We insertedan IUD in 97% of participants in the immediate group and76% in the delayed group (P

immediate compared with delayed IUD insertionafter first trimester suction abortion (n259), 106women were assigned to delayed insertion; 42% ofthese women (n43) never returned.12 Whether tim-ing of IUD insertion immediately after medical abor-tion affects subsequent utilization, bleeding, or re-moval compared with delayed insertion remainsunknown.

The goal of our study was to compare immedi-ate copper IUD insertion 1 week after medicalabortion to delayed copper IUD insertion 46weeks later. We hypothesized that more womenoffered immediate copper IUD insertion would un-dergo insertion and would be using the IUD at 6months compared with those offered delayed inser-tion. We also sought to compare rates of expulsion,removal, subsequent pregnancy, bleeding, and inser-tion pain in the immediate and delayed groups.

MATERIALS AND METHODSThis study was conducted at Columbia University Med-ical Center from July 2008 to October 2009 with ap-proval from the local Institutional Review Board.Healthy English-speaking or Spanish-speaking womenseeking medical abortion up to 63 days from the lastmenstrual period were eligible to enroll if they desireda copper IUD (ParaGard, DuraMed Pharmaceuticals,Pomona, NY) for contraception for at least 6 months.Additional inclusion criteria were a working tele-phone number and plans to be in the area for the next6 months. We excluded women with contraindica-tions to IUD use such as a documented cervicalgonorrhea or Chlamydia infection in the past 3months, a known bleeding diathesis, serum hemoglo-bin less than 10 g/dL, or an untreated high-gradesquamous intraepithelial lesion.

All women undergoing medical abortion re-ceived routine contraceptive counseling and thoseselecting the copper IUD were offered participationin the study. All participants provided written in-formed research consent. We screened participantsfor gonorrhea and Chlamydia infection unless screen-ing results were negative in the past 3 months. Theinvestigator or research assistant enrolled participantsand administered a baseline questionnaire to obtaindemographic, contraceptive, and pregnancy history.

We specified gestational age based on transvagi-nal ultrasonography and first day of last menses. Weadministered 200 mg of oral mifepristone in the officeand participants placed 800 micrograms of misopros-tol in the buccal mucosa at home 24 to 48 hours later.Supportive medicines included promethazine, ibu-profen, and acetaminophen with codeine. All partic-

ipants received a prescription for doxycycline 100 mgorally twice daily for 1 week as infection prophylaxis.Each participant received a 4-week diary to notebleeding, spotting, or cramping beginning with mife-pristone administration.

Participants returned 1 week after mifepristoneadministration per usual clinic protocol. Participantswho confirmed interest in the copper IUD weresequentially randomized by the investigator or re-search assistant using opaque numbered envelopes toeither immediate or delayed insertion of the IUD inan allocation ratio of 5:6, respectively. We decided torandomize more women into the delayed group inanticipation of greater loss to follow-up. After ran-domization, we performed a transvaginal ultrasoundexamination to ascertain if the abortion was complete(defined as absence of the gestational sac). Random-ization occurred before ultrasound examination toprevent selective exclusions based on ultrasound find-ings. Those randomized to the immediate groupunderwent IUD insertion during the same visit; thoserandomized to the delayed group received an ap-pointment to return for insertion 46 weeks aftermifepristone administration. In cases of a retained sac(without evidence of growth), we provided a repeatdose of misoprostol or vacuum aspiration according topatient preference. Continuing pregnancies were man-aged with vacuum aspiration. We also planned a priorito defer insertion for endometrial stripes thicker than 3cm. Participants requiring these further interventionsremained in the study and IUDs were inserted after theabortions were complete.

Participants received 800 mg of ibuprofen beforeinsertion and we performed a transvaginal ultrasoundexamination after insertion to document IUD locationin both groups. Insertion pain was rated on a 10-cmvisual analog scale twice: first before speculum insertion(baseline) and then again after the IUDwas inserted. Painin excess of baseline was attributed to IUD insertion.

We offered delayed group participants interimcontraception. If a participant did not return as sched-uled, we contacted her and offered another insertionappointment as soon as possible within the 6-monthstudy period.

We scheduled all participants for an IUD check 6to 8 weeks after placement, which included a trans-vaginal sonogram. We defined expulsion as eithermovement of the entire IUD into the vagina orpresence of any part of the IUD in the cervical canalon physical or ultrasound examination. We removedexpelled IUDs and offered reinsertion.

We contacted participants 3 months after enroll-ment to ascertain contraceptive use. An exit interview

624 Shimoni et al IUD Insertion Timing After Medical Abortion OBSTETRICS & GYNECOLOGY

was scheduled 6 months after enrollment; that visitincluded a transvaginal sonogram and satisfactionquestionnaire. We conducted the exit interview bytelephone if participants could not return or were nolonger using the IUD. Participants received up to $60for their participation. All visits occurred in theoutpatient setting. Study investigators were notblinded to study arm.

We decided a priori that a 20% difference in IUDutilization between the two groups at 6 months wouldbe clinically meaningful, and we assumed 70% ofparticipants in the delayed group and 90% in theimmediate group would be using the IUD at 6months.1315 These two assumptions, together with of 0.05 and 80% power, yielded a total sample sizeneeded of 142. We overenrolled to accommodate forloss to follow-up. A staff member not involved withenrollment used a random number table to generatethe allocation sequence. We performed statisticalanalyses using Microsoft Access and SAS 9.2. Wecompared categorical and continuous variables us-ing 2, Fisher exact test, Student t test, or Wilcoxon-Mann-Whitney U test, as appropriate. We usedintention-to-treat analysis for IUD utilization at 6months and per-protocol analysis for expulsionsand removals. We fitted a logistic model to com-pare bleeding in the two groups. Missing bleedingdata were excluded.

RESULTSWe enrolled 204 women. We excluded 48 partici-pants for failure to return for the randomization visit(n27), Chlamydia infection (n4), anemia (n1),and change of decision (n16). We randomized 156participants, 71 to immediate and 85 to delayed IUDinsertion (Fig. 1). Table 1 shows the two groups hadcomparable baseline characteristics. Nine percent ofparticipants (n14) were lost to follow-up. Threeparticipants still using the IUD at 6 months completedexit interviews by telephone.

Sixty-nine of 71 participants randomized to theimmediate group (97%) underwent IUD insertionduring the study. Two participants in the immediategroup declined IUD insertion after allocation. Incontrast, 65 of 85 randomized to the delayed group(76%) underwent IUD insertion (P.001).

Use of IUDs was greater in the immediate groupbut not statistically different; 69% (n49 of 71) ofimmediate group participants compared with 60%(n51 of 85) of delayed group participants were stillusing the IUD at 6 months (P.24).

Of participants randomized to the immediategroup, 56 underwent IUD insertion within 8 days ofmifepristone administration, eight between days 9and 14 of mifepristone administration, and five morethan 14 days after mifepristone administration. Twoimmediate group participants delayed insertion be-

EnrolledN=204

Randomizedn=156

Immediate insertionn=71

Delayed insertionn=85

IUD placedn=69; 97%

IUD placedn=65; 76%

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

IUD not placed: n=2Declined IUD: 2

Excluded: n=48Did not return for

randomization visit: 27Chlamydia: 4Anemia: 1Declined IUD: 16

Excluded after IUD placed: n=14 Lost to follow-up: 5IUD removed: 5IUD expelled, replaced, and

re-expelled: 1IUD expelled and not

replaced: 3

Excluded after IUD placed: n=20 Lost to follow-up: 5IUD removed: 10IUD expelled, replaced, and

re-expelled: 2IUD expelled and not

replaced: 3

IUD in place at 6 months*n=49; 69%

IUD in place at 6 monthsn=51; 60%

Fig. 1. Randomization and follow-upof study participants. Allocation intothe immediate and delayed groupswas performed in a ratio of 5:6. *The49 women include 46 women whoseintrauterine devices (IUDs) remainedin place throughout the study, andthree women whose IUDs were ex-pelled, replaced, and retained at 6months. The 51 women include 48women whose IUDs remained inplace throughout the study and threewomen whose IUDs were expelled,replaced, and retained at 6 months.Shimoni. IUD Insertion Timing AfterMedical Abortion. Obstet Gynecol2011.

VOL. 118, NO. 3, SEPTEMBER 2011 Shimoni et al IUD Insertion Timing After Medical Abortion 625

yond 8 days for management of a retained sac; bothparticipants had the IUD placed at the time of asuction aspiration. No other insertions were delayedfor ultrasound findings; other delays resulted fromlate follow-up (n10) and deferred IUD insertion(n1). In the delayed group, 60 participants had theIUD inserted within 42 days, and five delayed inser-tion further. Four delayed group participants pre-sented with retained sacs at follow-up. Managementoccurred with misoprostol or aspiration.

Expulsion of the IUD was similar in the twogroups: 12% (n8) in the immediate and 11% (n7)in the delayed group (P.88). Eight participantselected to have another IUD inserted after expulsion,four in each group. Of these reinsertions, two in theimmediate and one in the delayed group expelled theIUD again. Three expulsions in the immediate groupand four in the delayed group were diagnosed bysonogram only.

More IUD removals occurred in the immediategroup; however, this difference did not reach statisti-cal significance. Ten participants (14%) in the imme-diate group and five participants (8%) in the delayed

group requested removal during follow-up (P.21). Inboth groups, the most commonly cited reasons forremoval were bleeding and pain. Removals occurredthroughout the study in both groups. Number ofbleeding days reported on the 28-day bleeding diarydid not predict removal; participants requesting re-moval reported a median of 17 days (range 1027) ofbleeding or spotting, whereas those continuing to usethe IUD reported 20 days (range 628).

Four pregnancies occurred during the study, all inparticipants randomized to delayed insertion who didnot return for IUD insertion, whereas no pregnanciesoccurred in the immediate group (P.09). Two par-ticipants continued their pregnancies, one terminated,and one had a spontaneous abortion.

Participants returned 105 bleeding diaries, 45(63%) from immediate and 60 (71%) from delayedgroup participants, all initiated on the day of mifepri-stone administration and continued for 28 days. Im-mediate group participants reported a median of 20days (range 828) of bleeding or spotting during the28 diary days; delayed group participants reported amedian of 19 days (range 628; P.15). Immediateand delayed group participants reported cramping fora median of 5 days (range 024) and 4 days (range019) days, respectively (P.14).

Figure 2 compares the proportion of womenreporting bleeding or spotting in each group overtime. A logistic regression model did not find bleed-ing or spotting differences in the two groups (P.11).

Pain recorded on a visual analog scale duringIUD insertion increased a median of 10 mm (range44 to 93) from baseline in the immediate group and13 mm (range 43 to 80) in the delayed group

0.30.40.50.60.70.80.91.0 Immediate insertion

Delayed insertion

IUD inserted(immediate)

0.00.10.2

1 11 13 15 17 19 21 23 25 27

Days from medical abortion

Pro

porti

on re

porti

ng b

leed

ing

or s

potti

ng

IUD inserted(delayed)

3 5 7 9

Fig. 2. Bleeding patterns for days 128, starting withmifepristone administration.Shimoni. IUD Insertion Timing After Medical Abortion. ObstetGynecol 2011.

Table 1. Baseline Demographics of Immediateand Delayed Group Participants

Immediate(n71)

Delayed(n85)

Baseline characteristicAge (y) 26.96.0 26.45.8Gestational age (d) 49.36.7 48.47.3

Race or ethnicityNon-Hispanic 2 (3) 4 (5)Hispanic 69 (97) 81 (95)

EducationLess than high school 45 (63) 54 (64)High school degree 19 (27) 24 (28)Bachelor degree or more 7 (10) 7 (8)

Language spoken at homeEnglish 15 (21) 11 (13)Spanish 45 (63) 61 (72)Both 9 (13) 13 (15)

Past pregnancyNo 3 (4) 7 (8)Yes 68 (96) 78 (92)

Past birthNo 10 (14) 14 (16)Yes 61 (86) 71 (84)

Past birth control usedNo 4 (6) 5 (6)Yes 67 (94) 85 (94)

Past IUD useNo 66 (93) 79 (93)Yes 5 (7) 6 (7)

IUD, intrauterine device.Data are meanstandard deviation or n (%).

626 Shimoni et al IUD Insertion Timing After Medical Abortion OBSTETRICS & GYNECOLOGY

(P.30). There was no difference in pain before orduring insertion between the two groups (data notshown).

We identified no cases of serious infection, uter-ine perforation, hemorrhage, or anemia requiringIUD removal or transfusion. One IUD was inserted ina participant before review of results identifying aChlamydia infection. She was treated and the IUD wasleft in place. One ectopic pregnancy was identified,treated successfully with methotrexate, and the IUDwas subsequently inserted. Both participants wereincluded in the analysis. One delayed group partici-pant received a levonorgestrel intrauterine system.She was included in the analysis.

DISCUSSIONThis randomized trial examined timing of IUD inser-tion after medical abortion. Intrauterine copper con-traceptive uptake was significantly greater in womenoffered early insertion after medical abortion, with97% receiving the IUD compared with 76% in thedelayed group. We attribute this high level of uptaketo easy IUD access incorporated into the medicalabortion follow-up visit.

More women randomized to immediate insertionused the IUD at 6 months than those randomized tothe delayed group; however, this modest differencedid not reach statistical significance. Our study envi-ronment may have contributed to the smaller thanexpected difference between the two groups. In thisstudy, we provided close follow-up, flexible andprompt appointments, and free IUDs for participants.This seamless access likely resulted in a higher rate ofinsertion and use than would occur outside a researchsetting, especially for women delaying IUD insertion.

Early IUD insertion did not increase expulsions,which were similar in the two groups. Our expulsionrate is higher than reported in recent studies of IUDsinserted after suction abortion. When we exclude theeight expulsions diagnosed by sonogram only, ourexpulsion rate is similar to expulsion rates reportedelsewhere.3,16

The rate of IUD removal was greater among theimmediate group, although this difference did notreach statistical significance. Bleeding and pain werecommon reasons for removal in both groups andremovals occurred throughout the study in bothgroups. The reason for this modest removal differenceis unclear.

The four pregnancies in the study occurredamong the 20 delayed group participants who did notreturn for IUD insertion. This underscores the impor-

tance of early initiation of effective contraception inwomen after abortion.

Reported bleeding during the first 28 days aftermifepristone was similar in the two groups; early IUDinsertion did not increase the duration of bleeding.Prolonged bleeding or spotting is common after med-ical abortion; one study reported an average of 24days, which is consistent with our results.17 Empha-sizing the possibility of prolonged bleeding aftermedical abortion may improve IUD retention inwomen selecting early placement. Clinicians shouldbe reassured that early insertion is safe and will notsignificantly worsen bleeding or pain after medicalabortion.

Our study has limitations. We provided the intra-uterine copper contraceptive to participants; thus, ourresults may not be generalized to the levonorgestrelintrauterine system. This study was designed to detecta 20% difference in IUD use at 6 months. Theobserved difference at 6 months was only 9% and wasnot statistically significant. Differences in IUD inser-tion were substantial; however, both groups had lessIUD continuation than we expected. A larger studymay have demonstrated greater IUD utilization afterearly insertion, as seen in a recent study of IUDinsertion after uterine aspiration.3 Our study did nothave sufficient power to detect differences in second-ary outcomes. Because we only collected bleedingdiaries for 28 days, we cannot assess whether laterbleeding contributed to the removals requested bywomen in both groups.

Our data support that offering IUD insertion atthe medical abortion follow-up visit results in moreIUD insertions and is not associated with adverseoutcomes such as expulsion or more bleeding. Weconclude immediate intrauterine copper contracep-tive insertion after medical abortion should be offeredroutinely to patients.

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