India is the second most populous country in the world, contributing to 18% of the global population ¹ . In 1952, it 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 FP2020 goals aim to drive 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 through rolling out 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 . Increasing awareness and generating demand for family planning services through comprehensive media campaigns have also been prioritized. Reflecting this, data from India’s Demographic and Health Survey revealed that 72% of women reported hearing or seeing a family planning message in the past few months ⁴ .

Within the broader commitment to increase access and use of family planning services, a focus of the Government of India has also been to improve access to quality IUD services. It is recognized that ensuring the availability and quality of IUD services can improve family planning uptake, increase modern contraceptive methods use, and reduce unmet need for family planning services. While current use of IUDs among married women is low in India (1.5%), evidence suggests that contraceptive discontinuation rates are lowest for IUD methods (26%), as compared to other methods such as injectables (51%), condoms (47%), and pills (42%) ⁴ .

Evidence has shown that ensuring the quality of IUD services can lead to improved client satisfaction, a reduction in complications, continuation of IUD use, and increasing demand of IUD services ⁵ . Many factors contribute to the quality of IUD insertions, including the importance of an enabling environment, and assurance that the client’s rights are safeguarded ⁶ . In addition, studies have shown that the quality of IUD insertions may also get influenced by the skill level of the provider ⁶ . Evidence has also suggested that clients may be significantly more likely to experience IUD complications if they obtained their IUD from untrained providers ⁷ . Complications from IUD insertions is of concern given this can lead to unwanted pregnancies ⁸ , compromise patient safety ⁹ , and impose additional economic burden on the client ¹⁰ . Reduction in IUD complications may also enhance client satisfaction, increase demand for this family planning method and reduce negative beliefs about IUDs within the community ⁹ .

Since 2014, the international NGO, EngenderHealth has been providing technical assistance to the Government of India to improve access to quality IUD services. The project, “Expanding Access to IUD Services in India” (EAISI) has been implemented in Gujarat and Rajasthan districts. The interventions under the EAISI project include capacity building of service providers to provide quality IUD services, monitoring their compliance with standard practices, and strengthening the public health system by training administrators. The EAISI project trains public sector service providers in client assessment, counselling skills, IUD insertion and infection prevention practices, as well as ensuring services protect client’s sexual and reproductive health rights. Providers practice their skills on anatomic models and clients.

Estimation of complications of clinical procedures is an important outcome measure, as it has been an established outcome measure of quality of care ¹¹ . To the best of our knowledge, studies that have investigated the quality of IUD services ^{5, 6} , have not explored the importance of provider training and the extent to which this may influence the incidence of IUD complications. Given that follow-up information is routinely collected from IUD clients in India, the availability of facility data provided an opportunity to investigate factors associated with IUD complications. The primary aim of the study was to estimate factors associated with IUD complications, including the extent to which provider training influenced the rate of IUD complications. The rate of complications was deemed to serve as a proxy measure of the effectiveness of the EAISI project in reducing complications in the clients who have availed IUD insertion. A secondary aim of the study was also 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 women, and also present factors associated with this, including the training of the provider, the type of IUD, timing of the follow-up and timing of the insertion.

Globally, it is estimated that between 2% to 8% of IUD clients will experience missing strings ¹⁶ ; 1.6 per 1,000 women/years will have infections ¹⁷ ; and between 2 and 10% of IUD clients will experience expulsions in their first year ¹⁸ . Missing strings was the most common complication in insertions by EAISI-trained providers as well as in insertions by non-EASI trained providers. Our evidence 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 effort the Government of India and EngenderHealth have made to ensure the quality of IUD services.

Our results also illustrate 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 maintaining quality of IUD insertions and counselling of patients. The findings also demonstrate the importance of intensive, hands-on training of providers to build up their clinical skills to provide quality services and reduce post-insertion complications.

The findings that complications were significantly more common among women who returned for follow-up within 6 weeks, possibly reflects that clients noted some type of discomfort, or pain, or noted the expulsion and returned immediately to seek consultation. The finding that complications were significantly more frequent among clients with the IUD 380A has also been observed in other studies ¹⁹ . For example, while a clinical trial evaluating the effectiveness of the copper T 380A and multiload copper 375 (MLCU 375) IUD concluded that both types demonstrated comparable in performances in the first year of use, several issues with the 380A were noted. Clients who received the 380 A had higher discontinuation rates after a year, reported greater abdominal pain during menstruation and bleeding, and higher expulsion and termination rates than the 375 IUD ¹⁹ . The results of this study, and that of others, suggest that additional clinical research may be merited to explore the effectiveness of the copper T 380A in the context of India.

Timing was also significantly associated with complications, with women who received their IUD during the intra-caesarean period. This finding is consistent with other research, which reports unacceptably high expulsion and displacement rates among clients who receive IUDs during the intra-caesarean period. For example, one study observed a 20% expulsion rate among copper IUDs inserted during the intra-caesarean period, within the 12-week follow-up period ²⁰ . Another study found an IUD expulsion rate at 1 year of 17.6% in post-caesarean section women using the 380A IUD ²¹ . The method was viewed by the authors 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 leading to a shortened interpregnancy interval, which can lead to significant problems during a subsequent pregnancy ²² .

The age of the client was not significantly associated with incidence of complications, which contradicts other research that observed significantly higher rates of expulsion among younger women, under the age of 18 ²³ . Given that few of our sample comprised of women under the age of 18, and ranged from 16–45 years, with an average age of 25, may explain why no significant differences in age were observed among our sample.

This study had several limitations. Out of the sampled 176 facilities of Phase 1, 10 facilities had no records of follow-up clients. In addition, 81% of clients who had availed insertions from the remaining 166 facilities could not be documented. This was due to a number of reasons, including the low return rate of clients to facilities, poor documentation practices, and/or incomplete documentation. Although providers stress the importance of the need to returning to the facility for a follow-up after 1.5 months, it is apparent from our data that many do not. This lack of follow-up to the facility by the client may be attributable to a number of factors, including economic, geographical and logistical issues ^{24, 25} . As such, the estimation of complications may be biased towards women who were able to return for follow-up visits. Furthermore, the long-term expulsion rates could not be determined, as the vast majority of clients followed-up within 4 to 6 weeks. It is also recognized that complications could also have occurred due to other factors. Infections could also have occurred due to poor menstrual hygiene and sexual practices of the client. Missing strings could also have happened due to failure of IUD, or manipulation of strings by the client. These confounders may have been unevenly distributed among the clients who availed insertions from the EAISI-trained providers or from the other providers. Further, the category of non-EAISI trained providers in this study could have been trained on IUD insertion and related aspects during their pre-service and other post service training which could have masked the effect of IUD training on incidence of complications in our analyses. The limited fields in the hospital registers restricted our ability to control for these confounding variables. Finally, the caveats of the analysis framework were that the data was secondary, and the completeness of data could not be ensured.

Despite these limitations, the study demonstrates a cost-effective method of monitoring the quality of IUD services in healthcare facilities. While the other studies on quality of IUD services have derived data by interviewing providers, interaction with clients, or hospital operations indicators, the data in follow-up registers considered in this study, is filled after clinical evaluation, and carries expert assessment and diagnosis of complication or client’s condition. Since complications at the time of follow-up reflect the overall quality of IUD services including enabling environment, skills and practices of providers, and client satisfaction, this model denotes the effectiveness of IUD services in the real world. This analytical framework can be adopted to evaluate the outcomes of any skill-based training.

Training, follow-up practice and monitoring schemes used by the EAISI project could enhance the skills of the providers and improve the quality of IUD services. Based on this, the EAISI model can be used to scale up trainings to other geographic areas, by government or other partners. Besides this, the use of secondary data is cost-effective method of monitoring quality of IUD services. These findings create grounds for further research and presents feasible model for periodic assessment of the quality of IUD services in FP programs.

To facilitate such secondary analyses, follow-up registers should be made available at all the facilities, documentation practices should be improved, and reporting at facilities should be periodically reviewed. The data generated should be used for decision making and informing the implementers and policy makers, which will go a long way in enhancing quality of services.

Harvard Dataverse: Could Trained Providers Provide Better Quality of IUD Services-Results of A Secondary Data Analysis of Complications as a Proxy Indicator", 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).