A Comparative Evaluation of Cut 380A Intrauterine Device Versus Depot Medroxyprogesterone Acetate For Long-Acting Reversible Contraception

Abstract

Background:

India’s family-planning program increasingly emphasizes long-acting reversible contraceptives (LARCs) to curb unintended pregnancy. Copper T 380A (CuT 380A) intrauterine device (IUCD) and injectable depot medroxyprogesterone acetate (DMPA) are the two program-supported LARCs, yet granular comparative Indian data remain scarce.

Methods:

We undertook a prospective longitudinal study (November 2016–March 2018) at Safdarjung Hospital, New Delhi. Women choosing CuT 380A or DMPA were enrolled consecutively and stratified by timing of initiation—postpartum, postabortion, or interval. Baseline demographics, adverse events, continuation, discontinuation, expulsion, and pregnancy were recorded at 1, 3, 6, 9, and 12 months. Comparative statistics employed χ² or t-tests; P < 0.05 was significant.

Results:

A total of 162 women were analysed (81 per group), with a mean age of approximately 28 years. Baseline characteristics were comparable between groups. At 12 months, continuation was significantly higher with CuT 380A (74.0%) than DMPA (39.5%) (P < 0.001). Correspondingly, cumulative discontinuation was lower in the CuT 380A group (25.9%) compared with the DMPA group (53.0%). Expulsions occurred only in the CuT 380A group (7.4%). Bleeding disturbances were the most common adverse effect in both groups (CuT 380A 17.2%, DMPA 23.4%). Amenorrhoea increased progressively among DMPA users, reaching 29.6% at 12 months. Other adverse events were uncommon. Four pregnancies (4.9%) occurred in the CuT 380A group (two with the device in situ and two following partial expulsion), while no pregnancies were reported in the DMPA group. Overall satisfaction was significantly higher with CuT 380A (76.5% vs 46.9%, p < 0.001).

Conclusion:

Both LARCs were safe and highly effective; however, CuT 380A demonstrated superior 12-month continuation and satisfaction, whereas DMPA exhibited a higher drop-out largely driven by bleeding changes and desire for pregnancy. High-quality counselling on anticipated bleeding patterns could further optimize DMPA continuation.

INTRODUCTION

Long-acting reversible contraceptives (LARCs) combine high efficacy with user independence, making them pivotal to India’s efforts to reduce unintended pregnancy and achieve Sustainable Development Goal 3.7.1.[1] The copper-bearing IUCD remains the most widely used LARC globally,[2] yet injectables—particularly DMPA—have gained momentum following Government of India approval in 2016.[3] CuT 380A affords 10-year protection with a typical-use failure rate of <1 per 100 woman-years, comparable to female sterilization.[4] DMPA, administered trimonthly, has a similar failure rate (0.3/100 woman-years) and offers discreet, provider-controlled contraception without interfering with lactation.[5] Despite proven efficacy, real-world utilization hinges on acceptability and continuation. Postpartum and postabortion insertions/injections provide a strategic window before women exit care, yet they may influence expulsion, bleeding, or adherence differently from interval initiation.[6,7] Indian data directly comparing CuT 380A and DMPA across initiation timings are limited. A recent single-center study reported higher one-year IUCD continuation (76.2%) than DMPA (54.6%) but lacked detailed adverse-event profiling.[8] This prospective study therefore evaluated 12-month efficacy, continuation, acceptability, and safety of CuT 380A versus DMPA among postpartum, postabortion and interval users in a large tertiary institution in northern India.

MATERIALS AND METHODS

Design and setting

Prospective observational cohort (November 2016–March 2018), Department of Obstetrics and Gynaecology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi.

Participants

Consecutively consenting women ≥18 years selecting CuT 380A IUCD or DMPA for at least 12-month use and meeting WHO MEC 1–2. Exclusions: unexplained vaginal bleeding, category 3–4 contraindications, genital sepsis, or refusal of follow-up.

Interventions

IUCD: CuT 380A inserted postplacental (<10 min), early postpartum (10 min–48 h), postabortion (surgical or medical), or interval (>6 weeks) using Kelly’s forceps or standard no-touch technique.

DMPA: 150 mg intramuscular injection given within seven days of menses or immediately postpartum/abortion; reinjection scheduled 12 ± 2 weeks.

Follow-up

Clinic visits (1, 3, 6, 9, 12 months). Outcome measures: continuation/discontinuation (expulsion, removal, default), pregnancy, adverse events (bleeding patterns, pelvic pain, pelvic inflammatory disease [PDI], weight/bone changes), satisfaction.

Sample size

Based on anticipated continuation difference (76% vs 55%) with 80% power, α = 0.05, required n = 146; inflated by 10% for attrition → 162 (81 per arm).

Statistical analysis

SPSS v21.0; χ²/Fisher for categorical variables, Student’s t/Mann–Whitney for continuous data. Two-tailed P < 0.05 is deemed significant.

Ethical approval: Institutional Ethics Committee (VMMC/SJH/2016/112).

RESULTS

Cohort profile

Mean age was 28 ± 5.8 years; 59% were para 2; 71% urban; two-thirds of low socioeconomic status. Baseline characteristics were similar between arms [Table 1].

Table 1.

Baseline characteristics (n=162)

Characteristic	CuT 380A (n=81)	DMPA (n=81)	P
Age, mean±SD (y)	28.3±6.1	27.2±5.5	0.22
Para ≥ 2 n (%)	60 (74.1)	57 (70.4)	0.60
Literate n (%)	54 (66.7)	62 (76.5)	0.16
Urban residence n (%)	68 (83.9)	56 (69.2)	0.02
Low SES n (%)	52 (64.1)	54 (66.6)	0.24

Continuation and efficacy

Twelve-month continuation was 74% for CuT 380A vs 39.5% for DMPA (P < 0.001). Interval initiators fared best (96% vs 74%), followed by postpartum (66.6% vs 37%) and postabortion (59.2% vs 29.6%). Four pregnancies occurred in the IUCD arm (failure rate 4.9%); none occurred with DMPA [Table 2, Figure 1].

Table 2.

Continuation and pregnancy outcomes

Outcome	CuT 380A%	DMPA%	P
Continuation at 12 mo	74.0	39.5	<0.001
Discontinuation total	25.9	53.0	<0.001
– Expulsion	7.4	0	–
– Removal/default	18.5	53.0	–
Pregnancy	4.9	0	0.04

Figure 1.

% continuation over 12 months

Adverse events

Bleeding disturbances predominated: heavy/irregular bleeding in 17.2% (IUCD) and 23.4% (DMPA). Amenorrhea rose to 29.6% with DMPA at 12 months, but was rare with IUCD. Pelvic pain was higher with IUCD (22.2% vs 3.7%), whereas weight gain and headache/migraine were more frequent after DMPA [Table 3, Figure 2].

Table 3.

Cumulative adverse events to 12 months

Event	CuT 380A%	DMPA%
Heavy/irregular bleeding	17.2	23.4
Amenorrhea	1.2	29.6
Pelvic pain	22.2	3.7
PID	3.7	1.2
Weight gain >2 kg	2.4	8.6
Headache/migraine	1.2	8.6
Bone pain	2.4	4.9

Figure 2.

Incidence of adverse events within 12 months

PID occurred in three IUCD users (3.7%) and one DMPA user (1.2%), all resolving with outpatient antibiotics. No uterine perforation or injection-site infection was observed.

Discontinuation drivers

Expulsion accounted for 7.4% of IUCD losses. Removals were prompted by bleeding (7.4%), contraceptive failure (4.9%), and desire for pregnancy (2.4%). DMPA discontinuations were chiefly for menstrual changes (17.2%), pregnancy desire (16%), psychosocial factors (6.1%), and somatic complaints [Table 4].

Table 4.

Reasons for discontinuation

Reason	CuT 380A n (%)	DMPA n (%)
Bleeding problems	6 (7.4)	14 (17.2)
Device/drug failure	4 (4.9)	0
Expulsion	6 (7.4)	–
Desire for pregnancy	2 (2.4)	13 (16.0)
Pelvic pain/backache	1 (1.2)	3 (3.7)
Psychosocial/other	1 (1.2)	5 (6.1)

User satisfaction

At exit/12 months, 76.5% of IUCD users were satisfied versus 46.9% of DMPA users (P < 0.001).

DISCUSSION

This study provides a granular head-to-head assessment of the two LARCs currently promoted in India’s public program. Consistent with earlier international trials[9,10] and an Iranian cohort,[8] CuT 380A exhibited significantly higher 12-month continuation than DMPA. Continuation advantage persisted across initiation timings, underscoring inherent method-related drivers rather than postpartum physiology alone.

Bleeding changes emerged as the dominant adverse event for both arms, echoing WHO’s multicountry analysis of contraceptive discontinuation.[11] In our cohort, heavy/irregular bleeding was more troubling with DMPA, whereas CuT 380A users more often reported pelvic pain. Amenorrhea increased steadily with DMPA—a predictable pharmacologic effect—but paradoxically prompted discontinuation for some women, reflecting inadequate preinjection counselling. Structured counselling that frames amenorrhea as a benign, hemoglobin-sparing benefit has doubled DMPA continuation elsewhere.[12]

The 7.4% IUCD expulsion rate aligns with global postpartum insertion series (6–14%).[13] Most expulsions occurred within three months and were asymptomatic, highlighting the value of a routine six-week follow-up and self-string-check education. No expulsions occurred with interval insertions, reinforcing fundal placement as a key determinant. Notably, pregnancy occurred only with IUCDs—two after undocumented partial expulsion, two with mal-positioned devices—yielding a failure rate (0.5 per 100 woman-years) within established norms.[4] DMPA maintained perfect contraceptive efficacy, corroborating large US trials. Safety signals were reassuring: PID was infrequent and mild; no uterine perforations or injection-site infections were seen. Bone and weight concerns with DMPA were uncommon, though longer follow-up is warranted to monitor bone mineral density changes described elsewhere.[14]

Study strengths include prospective design, equal arm size, stratification by initiation timing, and very high follow-up, achieved via tele-reminders. Limitations comprise a single-center scope, a moderate sample size, and reliance on self-reported bleeding volume. Satisfaction was assessed by a simple global question rather than validated scales.

Implications for practice are clear. First, CuT 380A should remain the first-line LARC, particularly where return visits are uncertain. Second, DMPA fills an important niche for women seeking discreet, provider-controlled contraception or with IUCD contra-indications, but preinjection counselling must emphasize expected bleeding trajectories and timely reinjection. Third, integrating a structured six-week review for postpartum IUCDs can detect early expulsions, allowing reinsertion before fertility returns.

CONCLUSION

In a busy tertiary-care Indian setting, CuT 380A IUCD and DMPA were both safe and highly effective. However, CuT 380A achieved substantially superior 12-month continuation and user satisfaction, whereas DMPA experienced greater attrition from bleeding alterations and planned pregnancy. Strengthened, method-specific counselling—particularly on normalizing DMPA-related amenorrhea and scheduling reinjections—could narrow this gap.

Conflicts of interest

There are no conflicts of interest.

Funding Statement

Nil.