23/05/18

1

LENGTH OF ENDOMETRIAL CAVITY AND OTHER RISK FACTORS FOR IUD DISPLACEMENT, EXPULSIONS AND

REEXPULSIONS

ESC, Budapest, May 2018

Luis BahamondesProfessor of Gynaecology

Department of Obst & GynaecolUniversity of Campinas, Medical School

Campinas, SP, Brazil

COMMON IUCs WORLDWIDE

32 x 32 mm

52-mg LNG-IUS

28 x 30 mm

19.5-mg and 13.5-mg LNG-IUS

TCu380A IUD

32 x 32 mm

Multi Load 375IUD Nova T

36 x 38 mm31 x 33 mm24 x 30 mm35 x 19 mm

Gyne Fix

IUB

• For Cu-IUD and LNG-IUS: Bleeding disturbances

• For Cu-IUD and LNG-IUS: Pain at placement

• For Cu-IUD and LNG-IUS: Greater difficulty at placement among nulligravidas (?)

• For Cu-IUD and LNG-IUS: High expulsion rates among nulligravidas (?)

• Only for LNG-IUS Fear of hormonal effects

These concerns induced the:

Development of new Copper-IUD and new LNG-IUS with small size and low LNG dose

COMMON REASONS REPORTED BY HCPs AND WOMEN ABOUT IUC PLACEMENT DIFFICULTIES AND WHY THEY WANT

NEW SMALL IUC.

EVIDENCE IN IUC EXPULSIONS

• Between 2-10% of all insertions• More than 50% occurred in the first 6 months after placement

REPORTED ASSOCIATED FACTORS TO EXPULSION OF IUC• Young age

• Insertions performed by less skilled professionals• Post abortion and post partum insertion

• Heavy menstrual bleeding at time of insertion• Distorted cavity by uterine fibromas

HOWEVER• The length of endometrial cavity is not related to expulsions;

• The size of IUC is not related to expulsion.

Canadian Contraception Consensus (Part 3 of 4): Chapter 7 –Intrauterine Contraception. J Obstet Gynaecol Can 2016;38:182-222.

IT IS IMPORTANT THE ENDOMETRIAL LENGTH TO PREDICT EXPULSION?

Dragoman et al, Contraception 2016;94:195–201.J Minim Invasive Gynecol. 2018 Mar - Apr;25(3):411-417

TRUE UTERINE CAVITY LENGTH IS UNDERESTIMATED BY BLIND SOUNDING

23/05/18

2

DISTRIBUTION OF ENDOMETRIAL LENGTH (only cavity) (IN Cm) ASSESSED BY UTERINE SOUND (A) AND ULTRASOUND (B) (N=570).

Canteiro R et al. Contraception, 2010

Length of uterine cavity UTERINE SOUND (cm) ULTRASOUND (cm)

Minimum 2.5 2.2

Median 4.0 3.7

Maximum 6.0 6.5

Mean 4.06 3.78

S.D. 0.67 0.62

S.E.M. 0.02 0.02

DESCRIPTIVE VALUES OF THE ENDOMETRIAL LENGHT ASSESSED BY UTERINE SOUND AND ULTRASOUND (n=570)

Canteiro R et al. Contraception, 2010

ENDOMETRIAL CAVITY LENGTH OF THE 10 WOMEN WHOSE IUC WERE EXPELLED (n=395)

Participantnumber

Type ofIUC

Number ofpregnancies

Endometrial lengthby uterine sound, cm

Endometrial lengthby ultrasonography, cm

1 LNG-IUS 1 4.0 3.7

2 LNG-IUS 2 5.0 4.0

3 TCu380A 0 3.4 3.6

4 TCu380A 0 3.5 3.5

5 TCu380A 0 5.0 5.3

6 TCu380A 1 4.0 3.7

7 TCu380A 1 4.7 5.4

8 TCu380A 2 3.0 3.99 TCu380A 2 4.0 3.010 TCu380A 4 3.0 3.3

Int J Gynaecol Obstet. 2011 Apr;113(1):50-3

DISTRIBUTION OF CHANGE IN UTERINE LENGTH BEFORE AND AFTER TERM DELIVERY AMONG 495 INFERTILE WOMEN

J Matern Fetal Neonatal Med. 2014 Jul;27(10):989-93

GROSS CUMULATIVE RATES MLCu375 – 2 YEARS USE

Adv Contracept. 1993 Dec;9(4):285-90

0

1

2

3

4

5

6

7

8

9

Pregnancy Expulsion P < 0.01 Bleeding/Pain

ECL < 45mmECL > 45mm

%

WHO’s QUESTION: DOES CHECKING FOR THE PRESENCE OF AN

IUD STRING(s) INCREASE THE METHOD’S EFFECTIVENESS BY ALERTING THE USER

WHEN/IF AN EXPULSION HAS OCCURRED?

Dragoman et al, Contraception 2016;94:195–201.

23/05/18

3

TIME BETWEEN IUC PLACEMENT AND EXPULSION. CAMPINAS, BRAZIL

Month(s) between IUC placement and expulsion TCu380A (n=1532) SIU-LNG (n=254)

Between placement and month 6 49.1 % 54.3 %

7 to 12 11.8 % 14.6 %

13 to 24 12.3 % 15.0 %

Simonatto et al. J Obstet Gynaecol Res 2016;42(5):554-9.

TCu380A IUD and 52-mg LNG-IUS.NUMBER OF EXPULSIONS ACCORDING TO MONTHS OF USE

N=2,235 EXPULSIONS, CAMPINAS, BRAZIL

Number of expulsions according to months of use

Months

WOMEN AGE AND EXPULSION RATE

MYTH: ADOLESCENTS ARE PRONE TO EXPULSIONS IN COMPARISON TO ADULTS

WOMEN

EXPULSION RATE IN 52-mg LNG-IUS USERS OVER 3 YEARS

[N (%)].

16–35 years old

(n= 1600)

36–45 years old

(n= 151)

Total

(n= 1751)

56 (3.5) 6 (4.0) 62 (3.4)

Contraception. 2015 Jul;92(1):10-6.

ADJUSTED HAZARD RATIOS OF RISKS OF EXPULSION

VariableExpulsion

HR (95% CI) P-value

Age (y)

13–19Reference

20–24 0.79 (0.47–1.35) .39

25–35 0.68 (0.40–1.13) .14

IUD type

LNG-IUS Reference

Copper-IUD 1.62 (1.06–2.50) .03

Obstet Gynecol. 2014 Mar;123(3):585-92

CUMULATIVE PROBABILITY OF NOT HAVING AN INTRAUTERINE DEVICE EXPULSION STRATIFIED BY AGE.

Madden. IUD Expulsion. Obstet Gynecol 2014.

Higher expulsions at girls aged 14-19 years old

23/05/18

4

EXPULSION RATES OF IUDs AMONG ADOLESCENTS

Am J Obstet Gynecol 2017

Overall8%

PARITY AND EXPULSION RATE

MYTH: NULLIGRAVIDAS ARE PRONE TO EXPULSIONS IN COMPARISON TO PAROUS

WOMEN

CUMULATIVE PROBABILITY OF NOT HAVING AN IUC EXPULSION STRATIFIED BY PARITY

Madden. IUD Expulsion. Obstet Gynecol 2014.

TIME OF INSERTION:POSTPARTUM IUC PLACEMENT AND

EXPULSION RATE

CLINICAL OUTCOMES OF PPIUD BY MODE OF DELIVERY

Vaginal Delivery CaesareanDelivery P-value

Total women 137 73

Strings present on examd 93.1% (81/87) 44.2% (23/52) <.01

IUD present by ultrasounde 13.7% (13/95) 42.9% (24/56) <.01

IUD in place at 6 ws PP 84% (95/113) 100% (56/56) <.01

Insertions at CD are more likely to less expulsion (p<.01);IUC placed after CD are more likely to have nonvisible strings with a pelvicexam (p<.01) and undergo pelvic ultrasound evaluation (p<.01) compared to aPPIUD placed at the time of a VD.

Contraception 97 (2018) 215–218

Rate per 100 women/years p-value

Timing of insertion 0.4

Postpartum/postabortion 5.1

Interval 6.5

CUMULATIVE RATES OF EXPULSION OF COPPER-IUD AND LNG-IUS ACCORDING TO TIMING OF INSERTION. USA. N=1,164 WOMEN

Backman et al. EJCRHCare 2001;6:23-6.

23/05/18

5

LNG-IUS PLACEMENT AT THE TIME OF ACCUTE HMB EPISODE AND EXPULSION

All womenRegular

menstrual cycles

HMB

Expulsion 4.1 2.9 8.9

Number of placements 256 206 50

SMALL LNG-IUS AND EXPULSION RATE

PHASE III: THREE-YEAR OUTCOMES (JAYDESS)

Outcome Jaydess®

(N=1,432)

Partial and total expulsion, K-M analysis % 4.6

PROBALITY OF PARTIAL OR TOTAL EXPULSION AT MONTH 36, BY PARITY AND AGE (K-M ANALYSIS)

Probability of at leastpartial expulsion

Probability of total expulsion

LCS 12 and LCS 16

0 births 2.63% 0.84%

1 birth or more 4.92% 2.72%

Age ≤ 25 years 4.78% 2.42%

Age >25 <35 years 3.61% 1.77%

Total 4.05% 2.01%

PROBALITY OF PARTIAL OR TOTAL EXPULSION BY GROUP –ALL SUBJECTS TREATED WITH LCS16

23/05/18

6

LEVEL OF TRAINING OF THE HCP AND EXPULSION RATE Rate per 100

women/yearsp-value

HCP 0.37

Faculty member 5.7

Resident 7.0

CUMULATIVE RATES OF EXPULSION OF COPPER-IUD AND

LNG-IUS ACCORDING TO LEVEL OF TRAINING OF THE HCP.

USA. N=1,164 WOMEN

Backman et al. EJCRHCare 2001;6:23-6.

ULTRASOUND EXAMINATION REDUCE THE RISK OF EXPULSION?

DIAGRAM SHOWING A CORRECTLY PLACED IUD AS DETECTED BY ULTRASOUND

Contraception. 1996 Nov;54(5):287-9.

SCATTERGRAM OF THE IUD-MYOMETRIUM DISTANCE ACCORDING TO ENDOMETRIAL THICKNESS, EXCLUDING

SUBJECTS BELOW THE 90 PERCENTILE

Contraception. 1998 Jun;57(6):413-5.

WE CONCLUDE THAT THE T-SHAPED IUD ACCOMMODATES ITS

POSITION IN THE UTERINE CAVITY DURING THE FIRST 3 MONTHS

FOLLOWING INSERTION, AND THAT ULTRASOUND EVALUATION OF ITS

POSITION IS NOT A GOOD PREDICTOR OF FUTURE EVOLUTION.

23/05/18

7

IN CONCLUSIONVARIABLES ASSOCIATED TO HIGHER EXPULSION RATES

• Adolescents• LNG-IUS placement at the time of acute HMB episode

• First 6 months after IUC placement• Insertions performed by less skilled professionals

• Distorted cavity by uterine fibromas

CONFLICTED VARIABLES ASSOCIATED TO HIGHER EXPULSION RATES

Nulligravidas• Post partum insertion in comparison to CD placement

HOWEVER• The length of endometrial cavity is not related to expulsions;

• The size of IUC is not related to expulsion.