There were 3268 women who delivered in the two study hospitals during the recruitment period from 14th February to 13th May, 2018. Among these, 3178 (97.3%) were interviewed about their PPFP method uptakes of whom 943 (29.7%) had PPIUD insertions. In total 153 women who received PPIUD insertions and consented for the study were randomly selected for intensive follow up as exposures and 153 women who delivered immediately after the exposures were implicitly selected for follow-up as unexposures if they gave consent. Of the 306 women who were enrolled at least one weekly follow-up was done on 300 and 275 (90%) of these were followed up to the end point, at the end of 6th week post delivery. The analysis was with intention to treat (Figure 1).
Based on Table 1 results, the exposure and unexposure groups were comparable at enrolment except for a slightly more Cesarean section deliveries among the unexposed (27.2%) than the exposed group (18.3%), p=0.01.
The cumulative number of women that reported any medical complaint at any time during the 6 weeks’ follow-up was 78 (26.0%) including 41 (28.9%) in the exposed group and 37 of the 133(27.8%) women in the unexposed. This difference was not statistically significant (p=0.655). All the medical complaints were minor and 17 (22%) women among the 78 who reported any medical complaint sought medical treatment by contacting a health care provider or buying some medications from a medical store, commonly for pain relieaf. The most frequently reported symptoms over the 6-week follow-up were low abdominal pain (reported 60 times) followed by abnormal vaginal discharge (31 times). The least reported was vaginal bleeding (4 times). The cumulative frequencies of the individual medical symptoms are represented with shaded areas in Figure 2.
There were two peaks of medical symptoms in the course of 6-week follow-up. Most complaints were reported during the first (n=57) and second (n=28) weeks of delivery. There was another peak, albeit lower, during the 6th week. In all, there was no confirmed uterine infections.
Overall on the last day of the second week only 62 (21.6%) of all the interviewed participants (n=287) were dry and among them only 28 (10%) were dry for three consecutive days. As time progressed beyond the first week of follow-up, more women experienced intermittent dryness within the same week. On the last day of the fourth week 97 of the interviewed 279 women (=34.8%) were dry but only 58 (20.8%) were dry for 3 days consecutively. At the end of sixth week 235 (85.5%) were dry with 226 (82.2%) of them being dry for 3 consecutive days.
Overall 40 (14.6%) among 275 women who were analyzed at the end of their 6th week post-delivery had ongoing lochia discharges. Of the 142 women in the exposure group, 32 (22.5%) had continuing lochia at the end of 6th week compared to only 8 (6.0%) of the 133 unexposures, p<0.001. Likewise, 34(48.6%) women on Optima TCu380A, 5 (6.9%) of women on Pregna TCu380A and 10 (7.5%) of the unexposed had no experience of dryness for at least three consecutive days by end of 6th week.
The amount of lochia was indirectly estimated by scoring daily lochia discharges relative to the amount experienced on the day of delivery. The 5-Likert scale ranged from 0 (completely dry) to 4 (heavier than the day of birth). Throughout the 6 weeks of follow-up women in the exposure group had higher mean lochia scores compared to the unexposure group. The difference progressively increased towards the end of 6th week giving statistically significant weekly mean score varience for week 5 (F=3.818, p<0.001) and week 6 (F=2.949, p=0.004), Figure 3.
Among the 142 exposure women who completed a 6-week followup, 70 used Optima TCu380A (Injeflex Co. Brazil) device model and 72 had Pregna TCu380A (Pregna International, Chakan, India) device model.
By the end of the 6th week the mean lochia scores had dropped from 13.08 to 0.46 for Pregna TCu380A and from 11.97 to 0.43 for the unexposed group. For Optima the change was the least from 11.17 on the first week to 2.53 at the end of 6th week.
Marked weekly mean lochia score variations were observed for the two TCu380A IUD models used for PPIUD. Pregna was associated with persistently higher weekly lochia scores in the initial 4 weeks compared to the unexposed group but their progression to dryness by end of 6th week was comparable at the 6th week. Optima was associated with persistently lower weekly lochia scores in the initial four weeks but the rate of progression to dryness by the end of 6th week was slowest. All the observed mean weekly lochia score variations were statistically significant including F=11.37, p<0.001; F=12.32, p<0.001; F=6.71, p=0.001; F=6.71, p=0.001 and F=35.06, p<0.001 for the first week through the end of 6th week respectively.