India is the second most populous country in the world, contributing to 18% of the global population ¹ . In 1952, India became the first country in the developing world to introduce a national family planning program to lower fertility and stabilize population growth ² . India’s Family Planning 2020 (FP2020) goals aim to increase access, choice, and quality of family planning services. Since first making an FP2020 commitment in 2012, India has continued its efforts to expand the range and reach of contraceptive options by introducing new contraceptives and delivering a full range of family planning services at all levels. For example, India has integrated family planning into the Reproductive, Maternal, Newborn, Child, and Adolescent Health (RMNCH+A) Strategy ³ .

Global evidence has shown that ensuring the availability and quality of intrauterine device (IUD) services can improve family planning uptake, increase modern contraceptive method use, and reduce unmet need for family planning services. Understanding this, as part of its overall commitment to increasing access to and use of family planning services, the government prioritized improving access to quality IUD services. While IUD use among married women in India is low (1.5%), evidence suggests that discontinuation rates for IUDs are lower (26%) than all other contraceptive methods, such as injectables (51%), condoms (47%), and oral contraceptives (42%) ⁴ .

Increasing the quality of IUD services can improve client satisfaction, reduce complications, and increase demand for IUD services and continuation of IUD use ⁵ . Many factors contribute to the quality of IUD service delivery, including the enabling environment, safeguarding of clients’ rights, and provider skill levels ⁶ . Evidence has also suggested that clients who obtained IUDs from untrained providers are significantly more likely to experience IUD complications ⁷ and those complications can lead to unwanted pregnancies ⁸ , compromise client safety ⁹ , and impose an additional economic burden on clients ¹⁰ . Therefore, reducing IUD complications is important to improving client satisfaction and reducing negative perceptions about IUDs within the community, which in turn can increase demand for IUDs ⁹ .

Since 2014, EngenderHealth, an international sexual and reproductive health and rights organization, has been providing technical assistance to the government of India to improve access to quality IUD services. EngenderHealth implemented the Expanding Access to IUD Services in India (EAISI) project in Gujarat and Rajasthan through which EngenderHealth has built the capacity of service providers to deliver quality IUD services, monitored their compliance with standard practices, and strengthened the public health system by training administrators. More specifically, the EAISI project trains public sector service providers in assessing client needs, counseling clients, completing IUD insertions, adhering to infection prevention practices, and ensuring protection of clients’ sexual and reproductive health rights. As part of EAISI’s clinical training, providers practice on anatomic models and clients.

Estimating complications associated with clinical procedures is critical, as this is an established outcome measure of quality of care ¹¹ . For the EAISI project, the rate of complications served as a proxy measure of effectiveness in improving quality of IUD services. Few (if any) other studies that have investigated the quality of IUD services have explored the importance of provider training and the extent to which such training influences the incidence of IUD complications ^{5, 6} . Healthcare providers in India routinely collect follow-up information from IUD clients; the existing availability of such data provided an opportunity for investigating factors associated with IUD complications. The primary aim of this study was to examine factors associated with IUD complications, including the extent to which provider training influenced the rate of IUD complications. A secondary aim of the study was to estimate the magnitude of complications.

This study explored the frequency of complications among IUD clients across two states in India. Our findings highlight the frequency of complications among these clients and present factors associated with complications, including the training the provider received, the type of IUD, the timing of insertion, and timing of follow-up care.

Globally, 2% to 8% of IUD clients will experience missing strings within first year of insertion ¹⁶ , 1.6 of every 1,000 IUD clients will experience infection each year ¹⁷ , and 2% and 10% of IUD clients will experience expulsions in their first year ¹⁸ . Missing strings was the most common complication experienced by clients who received IUDs from either EAISI-trained providers and non-EAISI-trained providers. Our data suggest that the occurrence of missing strings, infection, and expulsion among our sample were lower than other studies. This is perhaps reflective of the efforts that the Indian government and EngenderHealth have made to ensure the quality of IUD services.

Our results also indicate that several factors are associated with the frequency of IUD complications. Of note, complications were significantly more common among clients who obtained their IUD from non-EAISI trained providers, a promising outcome from the EAISI project. These positive findings may reflect several efforts by the project to ensure that the providers are delivering high-quality counseling and clinical services to clients. The findings also demonstrate the importance of delivering intensive, practical, clinical training to providers to ensure they are able to deliver quality services thereby reducing subsequent complications.

The finding that complications were significantly more common among women who returned for follow-up care within six weeks may reflect that clients who experienced discomfort or pain or who noted the expulsion returned immediately for follow-up consultation. Other studies have also observed in the finding that complications were significantly more frequent among clients with the IUD 380A ¹⁹ . For example, while a clinical trial, implemented in Nigeria, evaluating the effectiveness of the copper T 380A and multiload copper 375 (MLCU 375) IUD concluded that both types of IUD demonstrated comparable in performances in the first year of use, the trial also identified several issues with the 380A. Clients who received the 380A reported higher discontinuation rates after one year, greater abdominal pain during menstruation and bleeding, and higher expulsion and termination rates than clients who received the 375 IUD ¹⁹ . The results of this study, and those of other studies, suggest that additional clinical research should explore the effectiveness of the copper T 380A in the context of India and other countries.

The timing of insertion was another significant variable associated with complications, with women who received their IUD during the intracesarean period experiencing the highest percentage of complications. This finding is consistent with other research, which reports unacceptably high expulsion and displacement rates among clients who receive IUDs during this period. For example, one study observed a 20% expulsion rate within the 12-week follow-up period among copper IUDs inserted during the intracesarean period ²⁰ . Another study reported an IUD expulsion rate at one year of 17.6% in intracesarean clients who received the 380A IUD ²¹ . As a result, the authors deemed the method as unacceptable for general use. These findings are of concern, given that the expulsion rates after caesarean delivery could prevent proper healing of the laparotomy wound by resulting in a decreased interpregnancy interval, and which can cause significant problems during subsequent pregnancies ²² .

Client age was not significantly associated with incidence of complications, contradicting other research that observed significantly higher rates of expulsion among women under the age of 18 ²³ . However, few of our sample clients—who overall ranged from 16–45 years of age with an average age of 25—were under the age of 18, which may explain the lack of significant differences associated with age among our sample.

This study had several limitations. First, of the 176 facilities sampled, 10 lacked records of follow-up clients. In addition, 81% of clients who had received insertions from the remaining 166 facilities were not documented due to a variety of reasons, including low client return rates, poor documentation practices, and/or incomplete documentation. Although providers stress the importance of returning to the facility for a follow-up visit after 1.5 months, clearly many clients do not return. This lack of follow-up may be attributable to a number of factors, including economic, geographic, and logistical issues ^{24, 25} . As such, our estimation of complications may be biased towards women who were able to return for follow-up care.

Furthermore, we could not comprehensively examine long-term expulsion rates, as the vast majority of clients sought follow-up care within four to six weeks. Due to resource constraints and incomplete secondary data, the team could not ensure a matched sample or conduct a case control study. The study team also recognized that other factors might have caused the complications observed. For example, sexually transmitted infections may have caused infections observed and IUD failures may have led to missing strings (although no such cases were reported). We also acknowledged that these confounders may have been unevenly distributed among the IUD clients who received insertions either from EAISI-trained providers or from non-EAISI-trained providers. The limited fields in the hospital registers hindered our ability to control for these confounding variables. Further, the non-EAISI-trained providers included in this study may have participated in other IUD trainings (for example, during preservice and/or in-service trainings) and received similar information as EAISI-trained providers, thereby misrepresenting the effect of EAISI-provided IUD training on incidence of complications in our analyses. Finally, the study team acknowledges that our analysis framework was constrained as we relied on secondary data and could not ensure the completeness of data.

Despite these limitations, the study demonstrates a cost-effective method of monitoring the quality of IUD services in healthcare facilities and illustrates the effectiveness of IUD services across patient settings. While the other studies examining quality of IUD services have derived data by interviewing providers, observing interactions with clients, or tracking hospital operations indicators, this study employed data from follow-up registers completed after clinical evaluation by the medical experts who assessed and diagnosed the client’s complication(s) or condition. Future studies can adopt this analytical framework to evaluate the outcomes of any skill-based training.

EAISI’s training, follow-up practice, and monitoring approaches proved to enhance providers’ skills and improve the quality of IUD services. The EAISI model can be introduced in other geographic areas, by the government or other partners, to replicate similar results. Our use of secondary data is a cost-effective method for monitoring the quality of IUD services. These findings establish a foundation for further research and present a feasible model for future assessments of the quality of IUD services in family planning programs.

To improve similar secondary analyses in the future, follow-up registers must be available at all participating facilities, facilities need to improve their documentation practices, and facilities should receive ongoing support to ensure accountability for this record keeping. The data generated should be shared with implementers, policymakers, and other key stakeholders to inform decision making and planning and to enhance the quality of services.

Dataverse: Potential for Improving Intrauterine Device (IUD) Service Delivery Quality: Results from a Secondary Data Analysis, https://doi.org/10.7910/DVN/JYZP7N ¹³ .

Data are available under the terms of the Creative Commons Zero “No rights reserved” data waiver (CC0 1.0 Public domain dedication) ¹³ .