Primary and Secondary Outcomes, by Type of Service Provider Performing the Procedure
| Outcome | Clinical Officer | Assistant Medical Officer | OR (95% CI) | P Value |
|---|---|---|---|---|
| Primary outcome | ||||
| Major AEs, n/N (%) | 0/978 (0.0) | 1/984 (0.1) | 0.0005 (0.00007, 0.0036) | .32 |
| Secondary outcomes | ||||
| Major and minor AEs at different time points during the study, n/N (%) | ||||
| Intraoperatively | 0/978 (0.0) | 0/984 (0.0) | NA | NA |
| Immediately postoperative | 0/978 (0.0) | 0/984 (0.0) | NA | NA |
| 3 days postoperative | 1/969 (0.1) | 0/976 (0.0) | 0.0005 (0.000072, 0.0036) | .32 |
| 7 days postoperative | 2/976 (0.2) | 3/975 (0.3) | 1.5 (0.3, 8.9) | .66 |
| Unscheduled postoperative visitsa | 1/4 (25.0) | 3/13 (23.1) | 0.80 (0.2, 3.0) | .94 |
| Performance of tubal occlusion by minilaparotomy | ||||
| Time to complete procedure, minutes, mean (SD [range]) | 26.0 (1.0 [14, 65]) | 26.0 (1.0 [15, 90) | NA | .42 |
| Requested verbal instruction from the supervisor due to difficulty performing the procedure,b n/N (%) | 15/978 (1.5) | 20/984 (2.0) | 0.75 (0.36, 1.56) | .40 |
| Requested the supervisor assist with the procedure,c n/N (%) | 14/978 (1.4) | 13/984 (1.3) | 1.08 (0.47, 2.52) | .80 |
| Inability to complete procedure,d n/N (%) | 2/978 (0.2) | 0/984 (0.0) | NA | .25 |
| Maximum pain during procedure,e mean (SD) | 4.12 (2.4) | 4.11 (2.4) | NA | .98 |
| Participant very satisfied with minilaparotomy, n/N (%) | 834/969 (86.1) | 831/976 (85.1) | 1.01 (0.88, 1.15) | .34 |
| Self-efficacy of providers in performing minilaparotomy,f mean (SD) | ||||
| General self-efficacy | 32.3 (6.1) | 31.3 (7.5) | NA | .79 |
| Confidence | 10.9 (0.9) | 11.5 (0.8) | NA | .21 |
| Comfort | 11.4 (0.5) | 10.9 (1.7) | NA | .41 |
Abbreviations: AE, adverse event; CI, confidence interval; NA, not applicable; OR, odds ratio; SD, standard deviation.
↵a All AEs observed during unscheduled visits occurred between Days 2 and 6 postoperatively.
↵b Most of these cases (n=21; 60.0%) involved difficulty locating or delivering the fallopian tube(s) due to obesity, adhesions, or unspecified reasons. Other reasons included unsettled/restless participant, abnormal uterus, difficulty placing the uterine elevator, and difficulty finding the uterus after the incision was made.
↵c These cases are a subset of those where verbal instruction was requested by the provider.
↵d In 1 case, the participant was unsettled because the procedure was taking a long time. She asked that they stop. In the other case, adhesions made delivering the right fallopian tube a problem. It was not possible to complete the procedure.
↵e 0=no pain, 10=worst pain possible.
↵f General self-efficacy scale: 10=lower self-efficacy, 40=higher; confidence and comfort scales: 3=lower confidence or comfort, 12=higher.