Table 4

Study outcomes

CitationResults
Beasley et al11Continuation
  • DMPA use at 1 year: (I) 71% (61/86); (C) 63% (29/46), p=0.47

  • Uninterrupted DMPA use at 1 year: (I) 47%; (C) 48%, p=0.70

  • Median number of days between the fourth and fifth injections: (I) 84 days (CI 84 to 89); (C) 84 days (CI 70 to 90), p=0.38

  • MPA level pg/mL among DMPA users at 12 months: (I) median: 640.8, mean: 695.8±318.5 pg/mL; (C) median: 641.0, mean: 686.2±309.6 pg/mL, p=0.85

Burke et al12Pregnancy: (I) 3/322; (C) 4/290, p=0.71.
Side effects or adverse events
  • Adverse events deemed potentially treatment-related: (I) 10/364 women (20 events); (C) 17/367 women (28 events)

  • Serious adverse deemed potentially treatment-related: (I) 1/364 women (2 events); (C) 0/367 women (0 event).

  • Any side effects


Month 3: (I) 91/355 (26%); (C) 110/342 (32%)
Month 6: (I) 55/324 (17%); (C) 56/254 (22%)
Month 9: (I) 41/306 (13%); (C) 38/213 (18%)
  • Abdominal pain, nausea, or vomiting


Month 3: (I) 40/91 (44%); (C) 54/110 (49%)
Month 6: (I) 27/55 (49%); (C) 25/56 (45%)
Month 9: (I) 19/41 (46%); (C) 12/38 (32%)
  • Irregular or heavy bleeding


Month 3: (I) 33/91 (36%); (C) 48/110 (44%)
Month 6: (I) 9/55 (16%); (C) 14/56 (25%)
Month 9: (I) 7/41 (17%); (C) 12/38 (32%)
  • Headaches


Month 3: (I) 29/91 (32%); (C) 48/110 (44%)
Month 6: (I) 17/55 (31%); (C) 19/56 (34%)
Month 9: (I) 13/41 (32%); (C) 14/38 (37%)
  • Injection site pain or irritation


Month 3: (I) 38/91 (42%); (C) 27/110 (25%)
Month 6: (I) 19/55 (35%); (C) 13/56 (23%)
Month 9: (I) 16/41 (39%); (C) 5/38 (13%)
  • Amenorrhoea


Month 3: (I) 32/91 (35%); (C) 32/110 (29%)
Month 6: (I) 28/55 (51%); (C) 22/56 (39%)
Month 9: (I) 24/41 (59%); (C) 14/38 (37%)
  • Backaches


Month 3: (I) 27/91 (30%); (C) 33/110 (30%)
Month 6: (I) 20/55 (36%); (C) 21/56 (38%)
Month 9: (I) 16/41 (39%); (C) 17/38 (45%)
  • Other aches or pains


Month 3: (I) 26/91 (29%); (C) 20/110 (18%)
Month 6: (I) 13/55 (24%); (C) 16/56 (29%)
Month 9: (I) 8/41 (20%); (C) 8/38 (21%)
  • Decreased libido


Month 3: (I) 15/91 (16%); (C) 15/110 (14%)
Month 6: (I) 9/55 (16%); (C) 9/56 (16%)
Month 9: (I) 5/41 (12%); (C) 11/38 (29%)
  • Weight changes


Month 3: (I) 5/91 (5%); (C) 9/110 (8%)
Month 6: (I) 7/55 (13%); (C) 8/56 (14%)
Month 9: (I) 1/41 (2%); (C) 11/38 (29%)
Continuation
  • DMPA-SC continuation at 1 year: (I) 73% (256/364); (C) 45% (157/367), log-rank p<0.0001

  • Incidence of discontinuation: (I) 8.2 per 100 injection cycles (6.7–10.0); (C) 20.6 per 100 injection cycles (17.9–23.7), IRR 0.40, 95% CI 0.31 to 0.51, p<0.0001

  • Cumulative number of discontinuations/number at risk


Month 0: (I) 1/364; (C) 0/367
Month 3: (I) 49/363; (C) 117/366
Month 6: (I) 79/309; (C) 165/245
Month 9: (I) 99/278; (C) 199/194
  • Sensitivity analysis with more lenient definition of continuation at 1 year: (I) 84%; (C) 53%, p<0.0001

  • Sensitivity analysis with more lenient definition of incidence of discontinuation: (I) 4.3 per 100 injection cycles (3.3–5.6); (C) 16.2 per 100 injection cycles (13.9–18.9), Interrater reliability (IRR) 0.27, 95% CI 0.19 to 0.36

Cameron et al, 2011Continuation
  • 12-month discontinuation rate: (I) 7/58 (12%), 95% CI 13% to 33%; (C) 14/64 (22%), 95% CI 6% to 23%, p=0.23


Side effects or adverse events
  • Amenorrhoea at 1 month: (I) 93% (52/56); (C) 90% (42/48)

  • Amenorrhoea at 12 months: (I) 96% (49/51); (C) 90% (34/39)

Cover et al15Pregnancy: (I) 3/561; (C) 2/600, not significant
Continuation
  • 12-month continuation cumulative probability: (I) 81%, 95% CI 78% to 84%; (C) 65%, 95% CI 61% to 69%

  • Sensitivity analysis (data not shown) with those lost to follow-up excluded from analysis also found significantly greater probability of continuation in the self-injection group.

  • Multivariate analysis of 12-month discontinuation


Main effects model: HR 0.54 (0.44–0.68), p=0.00
Interaction model (including age): HR 0.75 (0.56–0.99), p=0.05
Side effects or adverse events
  • Reported side effects


After first injection: (I) 161/539 (29.9%); (C) 197/580 (34.0%), p>0.05
After second injection: (I) 117/497 (23.5%); (C) 135/489 (27.6%), p>0.05
After third injection: (I) 88/473 (18.6%); (C) 98/432 (22.7%), p>0.05
  • Sought advice for side effects


After first injection: (I) 48/539 (8.9%); (C) 57/580 (9.8%), p>0.05
After second injection: (I) 33/497 (6.6%); (C) 47/489 (9.6%), p>0.05
After third injection: (I) 35/473 (7.4%); (C) 36/432 (8.3%), p>0.05
  • Reported ISRs


After first injection: (I) 33/539 (6.1%); (C) 8/580 (1.4%), p<0.05
After second injection: (I) 25/497 (5.0%); (C) 8/489 (1.6%), p<0.05
After third injection: (I) 38/473 (8.0%); (C) 5/432 (1.2%), p<0.05
  • Sought advice for ISR:


After first injection: (I) 0/539 (0%); (C) 2/580 (0.3%), p>0.05
After second injection: (I) 2/497 (0.4%); (C) 0/489 (0%), p>0.05
After third injection: (I) 3/473 (0.6%); (C) 2/432 (0.5%), p>0.05
Cover et al14Pregnancy: (I) 0/650; (C) 1/649
Continuation
  • 12-month continuation rate: (I) 80.2%; (C) 70.4%, p<0.001

  • Multivariate analysis of 12-month discontinuation: adjusted HR 0.72 (0.56–0.93), p=0.00


Side effects or adverse events
  • Serious adverse events


No serious adverse events were reported in either group.
  • Experienced side effects


After first injection: (I) 195/649 (30.1%); (C) 227/642 (35.4%), p=0.04
After second injection: (I) 130/615 (21.1%); (C) 155/598 (25/9%), p=0.05
After third injection: (I) 102/588 (17.4%); (C) 125/559 (22.4%), p=0.03
  • Sought treatment for side effects


After first injection: (I) 18/195 (9.2%); (C) 50/227 (22.0%), p=0.00
After second injection: (I) 17/130 (13.1%); (C) 32/155 (20.6%), p=0.09
After third injection: (I) 16/102 (15.7%); (C) 28/125 (22.4%), p=0.20
  • Experienced ISRs


After first injection: (I) 89/649 (13.7%); (C) 63/642 (9.8%), p=0.03
After second injection: (I) 52/615 (8.5%); (C) 55/598 (9.2%), p=0.65
After third injection: (I) 24/588 (4.9%); (C) 30/559 (5.4%), p=0.74
  • Sought treatment for ISR


After first injection: (I) 0/89 (0%); (C) 0/63 (0%), p= –
After second injection: (I) 0/52 (0%); (C) 0/55 (0%), p= –
After third injection: (I) 0/29 (0%); (C) 1/30 (3.3%), p=0.32
Kohn et al5Pregnancy: (I) 0/200; (C) 3/200
Continuation
  • 1-year continuous DMPA use: (I) 69%; (C) 54%, RD: 15%, 95% CI 5% to 26%, p=0.005.

  • 6-month continuous DMPA use: (I) 87%; (C) 69%, RD: 18%, 95% CI 9% to 27%, p<0.001.

  • Stratified analysis by age: ≤19 years: 67%, ≥20 years: 60%, p=0.46.

  • Relaxed definition of continuation (received four shots during the study period, any dose intervals): (I) 78%; (C) 64%, p=0.008.

  • Per-protocol sensitivity analysis removing women who were assigned to self-injection but had a nurse administer the first injection showed a consistent magnitude and direction of effect.

  • As-treated analysis reassigning self-administration subjects who crossed over to clinic group: (I) 68%; (C) 54%, RD: 14%, 95% CI 4% to 25%.

  • Sensitivity analysis classifying those who withdrew or were lost to follow-up as discontinued found a similar effect in direction and magnitude.

  • C, control;DMPA, depot medroxyprogesterone acetate; DMPA-SC, DMPA subcutaneous product; I, intervention;IRR, Interrater reliability; ISR, injection site reaction; RD, risk difference.