Unmet need for contraception during the postpartum period remains a persistent public health concern, particularly in low- and middle-income countries. Immediate postpartum intrauterine device (IUD) insertion has emerged as a highly effective and practical strategy to close this gap by providing long-acting reversible contraception (LARC) prior to hospital discharge [1,2]. In the Indian context, where counselling opportunities and follow-up visits may be limited, immediate postpartum contraception can offer a vital intervention point [1].

Among LARC options, the levonorgestrel-releasing intrauterine device (LNG-IUD) and the copper T 380A (CuT380A) are the most widely available and utilized. The CuT380A is cost-effective and hormone-free, but has been associated with higher expulsion rates, missing strings, and increased menstrual disturbances following immediate postpartum insertion [2,3]. In contrast, the LNG-IUD provides additional non-contraceptive benefits such as reduced menstrual bleeding and dysmenorrhoea, and is particularly suitable for women at risk of heavy postpartum bleeding—albeit at a higher cost [4].

Clinical outcomes such as expulsion and continuation are heavily influenced by the timing and technique of insertion. Prior studies, including those examining intra-caesarean insertions, have reported variable success depending on uterine involution and operator training [4,5]. Although both devices are deemed safe for use during breastfeeding and the postpartum period by major guidelines, such as the U.S. Selected Practice Recommendations [6], real-world data on their comparative performance remains limited, particularly in Indian tertiary-care settings.

This randomised controlled trial was conducted at Burdwan Medical College to assess and compare expulsion rates, 12-month continuation, and user satisfaction of immediate postpartum LNG-IUD versus CuT380A insertions, with the aim of informing evidence-based counselling and clinical decision-making in postpartum contraceptive care.

Objectives

Primary Objective:

• To compare the 12-month cumulative expulsion rate of LNG-IUD and CuT380A when inserted within 48 hours postpartum.

Secondary Objectives:

1. To assess the 12-month continuation rates in both groups.
2. To evaluate user satisfaction at 3, 6, and 12 months.
3. To document adverse effects including abnormal bleeding, pain, or infections.
4. To analyse reasons for discontinuation, if any.

Study Design and Setting: A parallel-group, open-label randomised controlled trial conducted at Burdwan Medical College over a 12-month period in the year 2024

Study Population: Postpartum women aged 18–45 years who delivered at the institution and consented to IUD insertion within 48 hours of delivery.

Inclusion Criteria:

• Women aged 18–45 years
• Vaginal or caesarean delivery at term
• Willing for immediate postpartum IUD
• No uterine anomalies or contraindications to IUD use

Exclusion Criteria:

• Postpartum haemorrhage or uterine atony
• Active genital tract infection
• Severe anaemia (Hb <8 g/dL)
• Known allergy to copper or levonorgestrel

Randomisation and Intervention: Participants (n = 300) were randomised 1:1 into two groups:

• Group A: LNG-IUD (n = 150)
• Group B: CuT380A (n = 150)

Randomisation was computer-generated with allocation concealment using opaque sealed envelopes. Devices were inserted within 48 hours postpartum by trained clinicians.

Data Collection: Data were collected through structured interviews and medical record reviews at designated time points. Trained staff recorded variables using pre-tested case report forms.

Variables Collected:

• Demographic data: Age, parity, residence (urban/rural), education level, socioeconomic status
• Clinical data: Mode of delivery, time of insertion, anaemia status (Hb), prior contraceptive use, history of menstrual irregularities
• Outcome variables: Device expulsion, continuation status, satisfaction scores (5-point Likert scale), adverse effects (bleeding, pain, infection), and reasons for discontinuation

Time Points for Data Collection:

• T0 (Baseline): Within 48 hours postpartum — Demographics, obstetric details, device type and insertion
• T1 (Early follow-up): 6 weeks — Initial expulsion check, early complications, satisfaction score
• T2 (Intermediate): 3 months — Expulsion, continuation, adverse events, satisfaction reassessment
• T3 (Mid-term): 6 months — Continuation status, adverse effects, satisfaction
• T4 (Final): 12 months — Cumulative expulsion, continuation, satisfaction, and any late complications

 Outcome Measures:

• Primary: Cumulative expulsion rate at 12 months
• Secondary: Continuation rate at 12 months, satisfaction scores, and incidence of adverse events

Statistical Analysis: Descriptive statistics were used to summarise baseline characteristics. Chi-square tests were used for categorical comparisons, and t-tests for continuous variables. Logistic regression analysed predictors of continuation and satisfaction. A p-value <0.05 was considered statistically significant.

This trial was approved by the Institutional Ethics Committee of Burdwan Medical College and registered in the Clinical Trials Registry - India (CTRI).

. Participant Flow and Follow-up Completion

Between July 2024 and June 2025, a total of 342 postpartum women were assessed for eligibility for inclusion in the study. Of these, 42 women were excluded prior to randomisation due to medical contraindications (n = 18), refusal to participate (n = 15), or delivery outside the defined study window (n = 9). The remaining 300 eligible participants were randomised in a 1:1 ratio to receive either the levonorgestrel-releasing intrauterine device (LNG-IUD) or the copper T380A (CuT380A), with 150 women allocated to each arm.

Follow-up at 12 months was completed by 274 participants, representing a follow-up rate of 91.3%. In the LNG-IUD group, 9 women were lost to follow-up and 4 withdrew consent, while in the CuT380A group, 10 were lost to follow-up and 3 withdrew. Per protocol analysis was therefore conducted for 137 participants in each group.

Figure1.Consort Flow Chart

2.Baseline Characteristics

The two groups were comparable across all key baseline variables. The mean age was similar between the LNG-IUD (26.2 ± 4.0 years) and CuT380A (26.3 ± 4.2 years) groups (p = 0.74). Most women were primiparous in both groups, with a modal parity of one. Vaginal deliveries were slightly more common than caesarean sections in both arms.

Urban residence was reported by approximately 44% of participants in both groups. Educational attainment (≥ high school) was marginally higher in the LNG-IUD group (67.2%) than in the CuT380A group (59.1%), though the difference was not statistically significant (p = 0.18). Anaemia at delivery (defined as Hb <11 g/dL) was prevalent in roughly one-third of participants across both groups (p = 0.70). These findings confirm that the randomisation achieved adequate baseline balance.

Table 1. Baseline Characteristics of Study Participants by Group (n = 274)

sub¹ Independent t-test; ² Chi-square test

3.Device Expulsion at 12 Months

At 12 months, the cumulative expulsion rate was significantly higher in the CuT380A group (26.3%) compared to the LNG-IUD group (11.7%). Early expulsions (within 6 weeks postpartum) occurred in 6.6% of LNG-IUD users and 9.5% of CuT380A users. However, late expulsions (between 6 weeks and 12 months) were markedly more frequent in the CuT380A group (17.5%) than in the LNG-IUD group (5.1%).

The overall difference in expulsion rates between the two groups was statistically significant (p < 0.01, χ² test). These findings suggest better long-term retention of the LNG-IUD compared to CuT380A when inserted in the immediate postpartum period.

Table 2. Expulsion Rates by Time Point and Group (n = 274)

Distribution of Device Expulsion by Time Point and Group

Figure 2. Distribution of Device Expulsion by Time Point and Group

A grouped bar chart comparing early and late expulsion frequencies between the LNG-IUD and CuT380A groups over 12 months.

4.Continuation and Reasons for Discontinuation

At the end of 12 months, the continuation rate was significantly higher in the LNG-IUD group (85.4%) compared to the CuT380A group (68.6%). Expulsion remained the leading cause of discontinuation in both arms—affecting 11.7% of LNG-IUD users and 27.0% of CuT380A users.

Other discontinuation reasons were infrequent and similarly distributed between groups. Voluntary removal occurred in 1.5% of LNG-IUD users and 2.2% of CuT380A users, typically due to a desire for pregnancy or perceived discomfort. Side effects (such as abnormal bleeding or cramping) led to removal in 1 LNG-IUD user and 2 CuT380A users. Follow-up attrition was minimal, with one woman lost to follow-up in each group.

Table 3. Continuation Status and Reasons for Discontinuation at 12 Months

5.Satisfaction Analysis

Mean satisfaction scores were consistently higher in the LNG-IUD group across all follow-up points. At 6 weeks, mean satisfaction was 4.2 ± 0.5 among LNG-IUD users compared to 3.8 ± 0.6 in the CuT380A group. Satisfaction increased progressively in the LNG-IUD group, reaching 4.5 ± 0.5 by 12 months. In contrast, satisfaction among CuT380A users declined over time, falling to 3.4 ± 0.6 at the final follow-up.

Between-group differences in mean satisfaction scores were statistically significant at all time points (p < 0.01, independent t-test). These trends are  shown in table 3 and visually summarised in Figure 3, which illustrates diverging satisfaction trajectories between the two arms.

Table 4. User Satisfaction Scores Over Time (1 = Very Dissatisfied; 5 = Very Satisfied)

                                      Satisfaction Trend Line

Figure 3. Mean user satisfaction scores over time in the LNG-IUD and CuT380A groups, measured at 6 weeks (T1), 3 months (T2), 6 months (T3), and 12 months (T4). LNG-IUD users showed consistently higher satisfaction with an upward trend, while CuT380A users exhibited declining satisfaction over time.

6. Adverse Effects and Safety Profile

Most women in both groups did not report any adverse effects over the 12-month follow-up. However, a greater proportion of CuT380A users experienced complications. Prolonged bleeding was the most commonly reported complaint—occurring in 12.4% of CuT380A users compared to only 5.8% of LNG-IUD users. Pelvic pain was reported by 8.0% of CuT380A users and 4.4% in the LNG-IUD group.

Rates of infection (2.2% vs. 0.7%) and device displacement (2.9% vs. 1.5%) were also marginally higher in the CuT380A group. Overall, adverse events were reported by 25.5% of CuT380A users and only 12.4% of LNG-IUD users, suggesting a more favourable safety profile for the levonorgestrel device.

These differences, although not statistically significant at all levels, are consistent with broader trends reported in similar literature, reinforcing the LNG-IUD’s tolerability in postpartum insertion.

Table 5. Adverse Effects Reported by Group Over 12 Months

7. Predictors of Continuation at 12 Months

Multivariate logistic regression analysis was performed to identify independent predictors of IUD continuation at 12 months. Although the direction of effect aligned with clinical expectations, none of the variables reached statistical significance in this model.

Women using CuT380A had lower odds of continuation compared to those with LNG-IUD (aOR 0.57, 95% CI: 0.15–2.10), but the difference was not significant (p = 0.397). Higher parity (aOR 1.35) and presence of adverse events (aOR 1.15) were also not independently associated with continuation.

Interestingly, expulsion showed a mathematically extreme but non-convergent effect due to its direct inverse relationship with continuation, highlighting a model instability at that node. The overall model did not detect strong predictors after adjusting for covariates, likely due to low event-per-variable ratios and high group-level correlation.

Table 6. Multivariate Logistic Regression Analysis for Continuation at 12 Months

Sub aOR = Adjusted Odds Ratio; CI = Confidence Interval

               Forest Plot for Adjusted Odds Ratios for Predictors of IUD Continuation at 12 Months.

Figure 4. Forest plot showing adjusted odds ratios (aOR) and 95% confidence intervals for predictors of IUD continuation at 12 months. CuT380A use and expulsion were associated with lower continuation compared to LNG-IUD, though most associations were not statistically significant. Error bars are plotted on a log scale.

This study compared immediate postpartum insertion of the levonorgestrel-releasing intrauterine device (LNG-IUD) with the copper T380A (CuT380A) in terms of expulsion, continuation, and user satisfaction over a 12-month period. Our results contribute meaningfully to a growing body of evidence evaluating long-acting reversible contraceptives (LARCs) in the postpartum setting.

Continuation rates were notably higher in the LNG-IUD group (85.4%) than among CuT380A users (68.6%), aligning with earlier findings by Zapata et al., who underscored the role of procedural ease, hormonal benefits, and side effect management in sustaining IUD use in clinical practice [7]. Zapata's systematic review highlighted that the addition of pre-insertion medications and improved counselling significantly reduced discomfort and improved acceptability. Our own counselling protocols and immediate postpartum insertions appear to mirror these patterns. While our multivariate analysis did not find statistically significant predictors of continuation, the directionality of the adjusted odds ratios supported the hypothesis that method type and expulsion are critical influencers. This is supported by Adams and Fosnight's overview of contraceptive adherence, which emphasized how device-specific tolerability and perceived user control shaped continuation decisions [8].

In line with Gupta and Elstein's broader psychological insights on contraceptive decision-making, LNG-IUD users reported progressively higher satisfaction scores at each follow-up interval, whereas satisfaction among CuT380A users declined [9]. This differential response highlights the value of hormonal modulation in user experience and is also reflected in our satisfaction scoring trends. Similar to findings by Gaza, who identified expulsion and irregular bleeding as major contributors to LARC discontinuation in low-resource settings, CuT380A users in our study reported more dissatisfaction and discontinuation linked to these specific side effects [10].

Expulsion rates in our study were notably higher among CuT380A users (27%) than in the LNG-IUD group (11.7%). Davidson et al. previously reported that postpartum insertion timing, uterine involution status, and device design may affect expulsion risks, with copper devices being particularly prone [11]. Harrison and Rosenfield contextualised this within broader contraceptive access challenges, arguing that predictable expulsion and reinsertion rates must be addressed through better postpartum protocols and counselling, especially when aiming to improve acceptability and reduce method switching [12].

The evolving satisfaction trends in our population resonate with the structured clinical feedback reported in Dutta and Konar's OSCE guidelines, where trainees were encouraged to offer LNG-IUDs for postpartum contraception given their superior satisfaction, convenience, and hormonal benefits [13]. Melkamu et al. further supported these dynamics in an Ethiopian cohort, where early discontinuation of implants and IUDs was strongly associated with pain, irregular bleeding, and lack of user preparation. In our study, 87.6% of LNG-IUD users reported no adverse effects, suggesting effective counselling and biologic tolerability [14].

Isa et al.'s retrospective review similarly found that pain and bleeding were the dominant reasons for discontinuation among CuT380A users in Nigeria, aligning well with our adverse event data and expulsion-linked removals [15]. Secura’s seminal work on LARC use emphasized the need for high-quality, ongoing follow-up and anticipatory guidance—components that may explain our strong continuation results, particularly among LNG-IUD users who had fewer complications and required less frequent interventions [16].

Finally, Ronsmans and Graham's global maternal health analysis supports our findings by advocating for timely, woman-centered contraceptive strategies to reduce maternal morbidity and unplanned pregnancies. Our study contributes further to this call by demonstrating that immediate postpartum LNG-IUD insertion is not only feasible and safe, but also well tolerated and effective in ensuring high user continuation at 12 months [17].

This study was limited by its single-centre design, which may affect generalisability. Additionally, reliance on self-reported satisfaction and potential recall bias during follow-up could influence subjective outcomes. Finally, the relatively small number of expulsion events limited statistical power for subgroup analysis.

Immediate postpartum insertion of the levonorgestrel-releasing intrauterine device (LNG-IUD) demonstrated higher continuation rates, lower expulsion rates, and greater user satisfaction at 12 months compared to the copper T380A (CuT380A). These findings support the use of LNG-IUD as a preferable long-acting contraceptive option in the immediate postpartum period, with implications for improving postpartum contraceptive uptake, user experience, and method retention in routine clinical settings.

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