Figures & Tables
Figures
Health facility staff discuss family planning options with women waiting for outreach services in northern Tanzania. © 2016 EngenderHealth
A clinical officer screens a woman for tubal ligation in a health facility in northern Tanzania. © 2014 EngenderHealth/S. Lewis
- FIGURE 1
Trial Profile
Abbreviations: AMO, assistant medical officers; CO, clinical officers.
a Randomization was done via a text message service. In these 2 cases, a cellular network outage prevented the study site from randomizing the participants.
b Just before the start of the procedure, 3 participants became nervous and withdrew consent.
c These participants were deemed to have met the study eligibility criteria and were randomized. However, before the procedure commenced, it was decided that they did not meet the criteria for the following reasons: anemia, high blood pressure, pelvic inflammatory disease, or unexplained vaginal bleeding.
d In this case, the participant was randomized, but a cellular network outage prevented the study site from determining the assigned random allocation group before the minilaparotomy procedure needed to be conducted for logistical reasons. The participant was discontinued.
e The procedure was not completed because the participant was unsettled, as the procedure was taking a long time. She asked that they stop the procedure.
f Adhesions made delivering the right tube a problem, and the procedure could not be completed, even with the supervisor's assistance.
- FIGURE 2
Interpretation of Risk Difference Between AMOs and COs for the Percentage of Women Experiencing a Major Adverse Event
Abbreviations: AMO, assistant medical officer; CI, confidence interval; CO, clinical officer.
The green diamond represents the point estimate of the risk difference (–0.1%) and the horizontal line to the left and right of the diamond represents the associated 2-sided 95% CI (–0.3%, 0.1%). Noninferiority of minilaparotomy performed by a CO is accepted because the upper limit of the 95% CI falls below the predefined noninferiority margin of 2%.
A woman undergoes tubal ligation by minilaparotomy in a health facility in northern Tanzania. © 2015 EngenderHealth/S. Lewis
Tables
- TABLE 1.
Background Characteristics of Service Providers Conducting Tubal Ligations in the Study
Clinical Officers (n=7) Assistant Medical Officers (n=7) 3-year CO training course ≥3 years of CO clinical work, plus 2-year AMO training course Sex Female 1 2 Male 6 5 Age, years, median (range) 29 (27, 57) 44 (36, 59) No. of years in career, median (range) 3 (2, 31) 7 (2, 12) Type of facilitya District hospital 2 3 Health center 5 6 Dispensary 1 1 Private hospital 1 0 No. with surgical experience before the minilaparotomy training 4 6 Frequency performing surgeryb Daily 0 1 Weekly (1–5/week) 2 4 Irregularly 2 1 No. reporting experience with types of surgeryb Abscess incision and drainage 1 3 Appendectomy 0 3 Cesarean delivery 0 6 Circumcision 3 0 Cyst excision 1 0 Hernia repair 0 1 Laparotomy for ruptured ectopic pregnancy 0 2 Lipoma removal 1 0 Wound repair 1 0 - TABLE 2.
Baseline Sociodemographic Characteristics of Minilaparotomy Participants, by Type of Service Provider Performing the Procedure
Characteristic Clinical Officer (N=978) Assistant Medical Officer (N=984) Total (N=1962) Age groups, years, No. (%) 18–24 2 (0.2) 2 (0.2) 4 (0.2) 25–30 38 (3.9) 34 (3.5) 72 (3.7) 31–35 149 (15.2) 140 (14.2) 289 (14.7) 36–40 526 (53.8) 514 (52.2) 1040 (53.0) 41–45 249 (25.5) 276 (28.1) 525 (26.8) 46–50 14 (1.4) 18 (1.8) 32 (1.6) Age, years, mean (SD [range]) 37.8 (3.9 [21–50]) 37.9 (3.7 [22–50]) 37.9 (3.8 [21–50]) Marital status, No. (%) Married/cohabitating 922 (94.3) 933 (94.8) 1855 (94.6) Divorced/separated 32 (3.3) 32 (3.3) 64 (3.3) Widowed 18 (1.8) 15 (1.5) 33 (1.7) Single 6 (0.6) 4 (0.4) 10 (0.5) Education level, No. (%) None 73 (7.5) 64 (6.5) 137 (7.0) Some primary 113 (11.6) 117 (11.9) 230 (11.7) Completed primary 713 (72.9) 721 (73.3) 1,434 (73.1) Some secondary 37 (3.8) 34 (3.5) 71 (3.6) Completed secondary 39 (4.0) 43 (4.4) 82 (4.2) Post-secondary 3 (0.3) 5 (0.5) 8 (0.4) Religion, No. (%) Lutheran 350 (35.8) 365 (37.2) 715 (36.5) Catholic 274 (28.0) 282 (28.7) 556 (28.3) Muslim 198 (20.3) 179 (18.2) 377 (19.2) Protestant 96 (9.8) 109 (11.1) 205 (10.4) Other 60 (6.1) 49 (5.0) 109 (5.6) Occupation, No. (%) Farmer 711 (72.7) 674 (68.5) 1385 (70.6) Small-scale business 183 (18.7) 209 (21.2) 392 (20.0) Housewife 30 (3.1) 56 (5.7) 86 (4.4) Teacher 17 (1.7) 18 (1.8) 35 (1.8) Other 29 (3.0) 18 (1.8) 47 (2.4) Missing 8 (0.8) 9 (0.9) 17 (0.9) - TABLE 3.
Baseline Measures of Obstetric History, Family Planning Use, and Reproductive Intentions of Minilaparotomy Participants, by Type of Service Provider Performing the Procedure
Characteristic Clinical Officer (N=978) Assistant Medical Officer (N=984) Total (N=1962) Ever pregnant, No. (%) 978 (100.0) 984 (100.0) 1962 (100.0) Outcome of pregnancies, No. (SD) Live birth 5.8 (1.6) 5.9 (1.6) 5.8 (1.6) Stillbirth 0.02 (0.2) 0.02 (0.2) 0.02 (0.2) Miscarriage/abortion 0.3 (0.6) 0.2 (0.6) 0.3 (0.6) No. of living children, No. (SD) Boys 3.0 (1.3) 3.0 (1.3) 3.0 (1.3) Girls 2.8 (1.3) 2.9 (1.3) 2.8 (1.3) Total 5.7 (1.5) 5.9 (1.6) 5.8 (1.6) Last family planning method used, No. (%) Injectables 371 (37.9) 402 (40.9) 773 (39.4) Implant 221 (22.6) 211 (21.4) 432 (22.0) Oral contraceptives 215 (22.0) 210 (21.3) 425 (21.7) Intrauterine device 43 (4.4) 46 (4.7) 89 (4.5) Male condom 27 (2.8) 22 (2.2) 49 (2.5) Periodic abstinence 4 (0.4) 10 (1.0) 14 (0.7) Withdrawal 8 (0.8) 6 (0.6) 14 (0.7) Lactational Amenorrhea Method 2 (0.2) 0 (0.0) 2 (0.1) None 87 (8.9) 77 (7.8) 164 (8.4) First heard about female sterilization from, No. (%) Health care provider 840 (85.9) 860 (87.4) 1,700 (86.7) Other sterilized person 53 (5.4) 38 (3.9) 91 (4.6) Friend or relative 50 (5.1) 40 (4.1) 90 (4.6) Spouse 19 (1.9) 22 (2.2) 41 (2.1) Community leader 4 (0.4) 11 (1.1) 15 (0.8) Public outreach worker 3 (0.3) 7 (0.7) 10 (0.5) Brochure 3 (0.3) 3 (0.3) 6 (0.3) Poster 3 (0.3) 2 (0.2) 5 (0.3) Radio 2 (0.2) 0 (0.0) 2 (0.1) TV 1 (0.1) 1 (0.1) 2 (0.1) Main reason for wanting female sterilization, No. (%) Desired family size completed 850 (86.9) 877 (89.1) 1,727 (88.0) Financial/economic reasons 72 (7.4) 51 (5.2) 123 (6.3) Health reasons 29 (3.0) 36 (3.7) 65 (3.3) Complications from a previous birth 18 (1.8) 15 (1.5) 33 (1.7) Encouraged by family, friend, or spouse 8 (0.8) 5 (0.5) 13 (0.6) Single mother with a disabled child 1 (0.1) 0 (0) 1 (0.1) Time since deciding not to have any more children, years, mean (SD [range]) 1.9 (2.1 [0.003,a 26]) 1.9 (2.0 [0.003,a 20]) 1.9 (2.1 [0.003,a 26]) ↵a 0.003 years=1 day.
- TABLE 4.
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.
- TABLE 5.
Additional Performance Measures, by Type of Service Provider Performing the Minilaparotomy Procedure
Clinical Officer (N=978) Assistant Medical Officer (N=984) Total (N=1962) P Value Additional local anesthesia injected during procedure, No. (%) 5 (0.5) 4 (0.4) 9 (0.5) .75 Change of anesthesia to general or spinal, No. (%) 0 (0.0) 0 (0.0) 0 (0.0) NA Estimated incision length 2–3 cm, No. (%) 978 (100.0) 984 (100.0) 1962 (100.0) NA Extension of abdominal incision needed, No. (%) 0 (0.0) 1 (0.1) 1 (0.1) 1.0 Switch to laparotomy, No. (%) 0 (0.0) 0 (0.0) 0 (0.0) NA Discharged well from facility on day of procedure, No. (%) 978 (100.0) 984 (100.0) 1962 (100.0) NA
In this issue
Statistics from Altmetric.com
Jump to section
Related Articles
Cited By...
- No citing articles found.