Copper intrauterine device use by nulliparous women: review of side effects

doi:10.1016/j.contraception.2006.12.005

Contraception

Volume 75, Issue 6, Supplement, June 2007, Pages S8-S11

https://doi.org/10.1016/j.contraception.2006.12.005 Get rights and content

Abstract

Background

Nulliparity was once a relative contraindication to using the copper IUD. However, new research and changes in product labeling have eased safety concerns. Side effects remain a major problem with copper IUD use in this population.

Methods

A review of published articles was undertaken to find information on expulsion rates and removals for bleeding and pain among nulliparous women using a copper IUD; approximately 500 articles and abstracts were found.

Results

In 15 studies comparing IUD performance in parous vs. nulliparous women, nulliparous women had higher rates of expulsion and removals due to bleeding and pain. Among 8 studies examining different types of copper IUDs in nulliparous women, some evidence suggests IUD size and shape play a role in performance.

Conclusion

All existing copper IUDs are suitable for use by nulliparous women. However, more research is needed to determine whether expulsions and removals due to bleeding and pain can be reduced with improved copper devices.

Introduction

When the CuT380A intrauterine device (IUD) was first marketed in the US in 1988, the product label contained a section titled “Recommended patient profile.” Within this section was the following phrase: “T380A is recommended for women who have had at least one child….” This feature of the product label and restrictive practices by clinicians limited use of the IUD among nulliparous women in the United States and elsewhere. In September 2005, however, the U.S. Food and Drug Administration approved a new product label for the CuT380A; it is now void of any language to discourage use by nulliparous women.

If more nulliparous women are going to use copper IUDs, then it is important to know if the CuT380A is the optimal device or whether other devices perform better. A recent review on copper IUDs [1] found that in comparative studies (in mostly parous women) the CuT380A was superior to other devices in terms of contraceptive efficacy, yet not clearly superior in terms of expulsions and removals due to bleeding and pain. Childbirth has unclear effects on subsequent IUD performance, yet a larger uterus may reduce side effects from a framed copper device. The size of the uterine cavity (depth and width) has been shown to increase with parity [2].

Section snippets

Materials and methods

A systematic review of the literature was conducted to summarize information on copper IUD expulsions and removals for bleeding and pain among nulliparous/nulligravid women. As a first step, the papers cited in a recent Cochrane library publication on copper IUDs [1] were reviewed for information on nulliparous women, including results from 35 randomized trials (included in the meta-analysis) and 34 additional trials (excluded from the meta-analysis for various reasons). In addition, 307

Results

A total of 20 different published papers contributed to this review of copper IUD use by nulliparous women; they all contained information on (1) expulsions or IUD removals due to bleeding and pain and (2) internal comparisons. In nearly all of the papers, no information was available on the number of nulligravid women included in the nulliparous population and, thus, it was not feasible to provide this possible distinction in the analysis presented here. For ease of reporting, only the label

Discussion

This systematic review of the literature on copper IUD use among nulliparous women revealed that, in general, nulliparous women experience higher rates of expulsion and removals for bleeding and/or pain compared with parous women. Also, the review found some evidence that among nulliparous women, event rates may vary by type of device; in particular, smaller framed devices may have lower rates compared with their standard-sized comparisons.

Nulliparous women who need or want better nonhormonal

Acknowledgment

Support for this review was provided by Family Health International (FHI) with funds from the U.S. Agency for International Development (AID/CCP-A-00-95-00022-00), although the views expressed in this publication do not necessarily reflect those of FHI or other participating institutions. The author thanks Carol Manion and Sonja Jerome for literature searches and library assistance.

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Cited by (99)

Menstrual cup use and intrauterine device expulsion in a copper intrauterine device randomized trial
2024, Contraception
To evaluate menstrual cup use and intrauterine device (IUD) expulsion.
We performed a secondary analysis of a 3-year contraceptive efficacy trial comparing two copper 380 mm² IUDs. Investigators randomized participants approximately 1:4 to the TCu380A or NTCu380-Mini IUD. Approximately 12 months after enrollment began, we advised participants against menstrual cup use due to observed IUD expulsions in cup users. We evaluated IUD expulsion (including spontaneous partial and complete expulsion and accidental self-removal) at 12 and 36 months. We used multivariable logistic regression to evaluate IUD expulsion by age, baseline menstrual volume, body mass index, IUD type, menstrual cup use, parity, and uterine length.
This analysis included 1046 participants (203 TCu380A and 843 NTCu380-Mini), with 879 (84.0%) nulliparas. Through 12 and 36 months, expulsion occurred in 74 (7.1%, 95% CI 5.5–8.6%) and 133 (12.7%, 95% CI 10.7–14.7%) participants, respectively. Overall, 250 (23.9%) reported menstrual cup use. More menstrual cup users than non-users experienced expulsion through 12 months (32/203 [15.8%] vs. 42/843 [5.0%]) and 36 months (58/250 [23.2%] vs. 75/796 [9.4%]). Through 36 months, NTCu380-Mini menstrual cup users had higher expulsion odds, while TCu380A cup users did not. Menstrual cup users more frequently experienced accidental self-removal than non-users in participants using the TCu380A (3/53 [5.7%] vs. 0/150 [0.0%]) and the NTCu380-Mini (20/197 [10.2%] vs. 7/646 [1.1%]). In multivariable regression, we found increased odds of expulsion through 36 months in participants using menstrual cups with the NTCu380-Mini (aOR 3.13, 95% CI 1.16–8.46) and <25 years (aOR 1.59, 95% CI 1.07–2.34).
We found higher odds of IUD expulsion with menstrual cup and concurrent NTCu380-Mini IUD use over 36 months of use, but not with concurrent TCu380A IUD use. Menstrual cup users experienced higher likelihood of accidental self-removal regardless of IUD type.
Menstrual cup and NTCu380-Mini use may increase IUD expulsion risk and may increase accidental self-removal risk with TCu380A and NTCu380-Mini use. Clinicians should advise patients of these risks and consider warning patients using an IUD shaped like the NTCu380-Mini (Nova-T frames) of expulsion risk with menstrual cup use.
Continuation rates of two different-sized copper intrauterine devices among nulliparous women: Interim 12-month results of a single-blind, randomised, multicentre trial
2022, eClinicalMedicine
The most widely used copper intrauterine device (IUD) in the world (the TCu380A), and the only product available in many countries, causes side effects and early removals for many users. These problems are exacerbated in nulliparous women, who have smaller uterine cavities compared to parous women. We compared first-year continuation rates and reasons/probabilities for early removal of the TCu380A versus a smaller Belgian copper IUD among nulliparous users.
This 12-month interim report is derived from a pre-planned interim analysis of a sub population and focused on key secondary comparative endpoints. In this participant-blinded trial at 16 centres in the USA, we randomised participants aged 17–40 in a 4:1 ratio to the NT380-Mini or the TCu380A. In the first year, participants had follow-up visits at 6-weeks and 3, 6, and 12-months, and a phone contact at 9 months; we documented continued use, expulsions, and reasons for removal. Among participants with successful IUD placement, we compared probabilities of IUD continuation and specific reasons for discontinuation using log-rank tests. This trial is registered with ClinicalTrials.gov number NCT03124160 and is closed to recruitment.
Between June 1, 2017, and February 25, 2019, we assigned 927 nulliparous women to either the NT380-Mini (n = 744) or the TCu380A (n = 183); the analysis population was 732 (NT380-Mini) and 176 (TCu380A). Participants using the NT380-Mini, compared to the TCu380A, had higher 12-month continuation rates (78·7% [95% CI: 72·9–84·5%] vs. 70·2% [95% CI: 59·7–80·7], p = 0·014), lower rates of removal for bleeding and/or pain (8·1% vs. 16·2%, p = 0·003) and lower IUD expulsion rates (4·8% vs. 8·9%, p = 0·023), respectively.
The NT380-Mini offers important benefits for a nulliparous population compared to the TCu380A in the first twelve months, when pivotal experiences typically occur. Higher continuation rates with the NT380-Mini may avert disruptions in contraceptive use and help users avoid unintended pregnancy.
Bill & Melinda Gates Foundation, Eunice Kennedy Shriver National Institute of Child Health and Human Development, and Mona Lisa, N.V. (Belgium).
Copper-containing intrauterine device (cIUD): Comparison of tolerance and efficacy in nulliparous and parous women over 6 months
2021, Gynecologie Obstetrique Fertilite et Senologie
Le dispositif intra-utérin au cuivre (DIUc) est un moyen de contraception, non hormonal, efficace et de longue durée d’action et peu utilisé chez les patientes nullipares en France. Les objectifs de l’étude sont de comparer la tolérance du DIUc par le taux de continuation à 6 mois entre des patientes nullipares et des patientes multipares, et d’évaluer les complications et effets secondaires à la pose et au cours du suivi.
Il s’agit d’une étude épidémiologique prospective multicentrique avec suivi pendant 6 mois. Les patientes majeures ont été incluses à Nantes de février 2019 à octobre 2019 lors de la pose de DIUc dans les différents centres : le service de santé des étudiants (SUMPPS) (Nantes), le centre Clotilde de Vautier de la clinique Jules Verne (Nantes) et dans les cabinets de gynécologues de Nantes.
Au total, 94 patientes ont été incluses lors de la pose du DIUc. À 6 mois, 77 patientes ont répondu au deuxième questionnaire, 49 patientes étaient nullipares et 28 étaient multipares. La douleur à la pose était supérieure chez les nullipares avec une EVA de 6,5 ± 2,4 (0–10) pour 3,9 ± 2,2 (0–8) pour les patientes multipares (p < 10⁻⁴). Le taux de continuation à 6 mois du DIUc étaient de 92,8 % pour les multipares et 83,4 % pour les patientes nullipares, sans différence significative (p = 0,25). L’expulsion était la seule complication retrouvée avec 12,2 % chez les nullipares et 3,5 % chez les multipares (p = 0,40). Par ailleurs, 64 % des patientes observaient des règles d’abondance supérieure à avant sans différence avec la parité, et 72 % des nullipares déclaraient avoir des dysménorrhées nécessitant la prise d’antalgiques, contre 47 % des multipares (p = 0,025). Les nullipares étaient très satisfaites ou satisfaites pour 89 % dans la vie quotidienne et 96 % d’entre elles dans la vie sexuelle, sans différence avec les multipares (respectivement 97 % et 100 %).
Il n’y pas de différence sur le taux de continuation à 6 mois entre les nullipares et les multipares. Les nullipares se plaignaient plus souvent de dysménorrhées par rapport à la période avant le DIUc. Les taux de satisfaction étaient comparables.
The copper-containing intra-uterine device IUD (cIUD) is a non-hormonal, effective, long-acting method of contraception, which is not widely used in nulliparous patients in France. The objectives of the study are to compare the safety of the cIUD by the rate of continuation at 6 months between nulliparous and parous patients, and to assess the complications and side effects at insertion and during follow-up.
Material and method This is a multicenter prospective epidemiological study with follow-up for 6 months. The adult patients were included in Nantes from February 2019 to October 2019 during the insertion of a IUD in different centers: the student health service (SUMPPS) (Nantes), the Clotilde de Vautier center in the Clinic Jules Verne (Nantes) and in the gynecological offices of the city of Nantes.
A total of 94 patients were included during the insertion of the cIUD. At 6 months, 77 patients answered the second questionnaire, 49 patients were nulliparous and 28 were parous. The pain on insertion was greater in nulliparous patients with a VAS of 6.5 ± 2.4 (0–10) versus 3.9 ± 2.2 (0–8) for multiparous patients (P < 10⁻⁴). The 6-month continuation rate for the cIUD was 92.8% for 83.4% for nulliparous patients, and parous patients with no significant difference (P = 0.25). Expulsion was the only complication found with 12.2% in nulliparous and 3.5% in parous (P = 0.40). Otherwise, 64% of the patients observed heavy bleeding than before without difference with the parity, and 72% of the nulliparous declared to have dysmenorrhea requiring the use of analgesics, against 47% of the parous (P = 0.025). The nulliparous were very satisfied or satisfied for 89% in daily life and 96% of them in sex life, without difference compared to parous (97% and 100% respectively).
There is no difference in the rate of continuation at 6 months between nulliparous and parous. Nulliparous complained more often of dysmenorrhea in comparison to the period before the cIUD. The satisfaction rates were comparable.
Misconceptions and Beliefs Regarding the Use of Intrauterine Devices for Nulliparous Women Among Chinese Health Care Providers
2020, Journal of Pediatric and Adolescent Gynecology
To investigate the knowledge and beliefs regarding the use of intrauterine devices (IUDs) for nulliparous women among Chinese health care providers and assess the potential factors related to their misconceptions and conservative beliefs.
A self-administered survey was conducted at 2 Chinese national academic conferences in 2015. The questionnaire data obtained from 103 health care providers were analyzed to examine the providers’ knowledge regarding the safety and effectiveness of IUDs and the complications associated with IUD use, as well as their beliefs regarding the suitability of IUDs for nulliparous women. An ordinal logistic regression model was used to evaluate the potential factors related to their beliefs.
Misconceptions about the complications associated with IUD use were common among our respondents, and they were least likely to know that IUDs do not increase the risk of developing pelvic inflammatory disease (26/97) or ectopic pregnancy (23/102) (22.5%-26.8%). Only approximately 10% of the providers believed that adolescents (9/94) or unmarried nulliparas (10/95) could be candidates for IUDs. In contrast, they were more likely (37/96, 38.5%) to consider married nulliparous women as appropriate candidates (P < .001). Misconceptions about the complications of IUD use were associated with more conservative beliefs regarding IUD use for nulliparous women (adjusted odds ratio, 1.34; 95% confidence interval, 1.00-1.79).
The health care providers' insufficient knowledge regarding IUDs contributed to their outdated and conservative beliefs about the suitability of IUDs for nulliparous women. In addition, the difference in the providers’ beliefs regarding IUD use for married and unmarried nulliparous women might reflect the stigma associated with premarital sex in Chinese traditional culture.
Practical Tips for Intrauterine Device Counseling, Insertion, and Pain Relief in Adolescents: An Update
2019, Journal of Pediatric and Adolescent Gynecology
The American Academy of Pediatrics and the American College of Obstetricians and Gynecologists have endorsed intrauterine devices as first-line contraceptive choices for nulliparous and parous adolescents. Practical concerns about intrauterine devices might be barriers to use for teens and clinicians; this review is devoted to “practical tips” for clinicians, on the basis of an update of the available literature as well as the author's clinical experience. Counseling about contraceptive choices, preventive guidance about possible side effects, informed consent, and pain management are addressed to promote successful use of this long-acting reversible contraption option.
Historical record-setting trends in IUD use in the United States
2018, Contraception

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Review articleCopper intrauterine device use by nulliparous women: review of side effects

Abstract

Background

Methods

Results

Conclusion

Introduction

Section snippets

Materials and methods

Results

Discussion

Acknowledgment

Contraception

Contraception

Contraception

Contraception

Contraception

Contraception

Am J Obstet Gynecol

Contraception

Contraception

Contraception

Copper containing, framed intra-uterine devices for contraception

Cochrane Database Syst Rev

A randomised trial and a comparative study of the copper 7 200 and the multiload copper 250 intrauterine devices

Aust N Z J Obstet Gynaecol

Review article
Copper intrauterine device use by nulliparous women: review of side effects