Effect of the timing of insertion of postpartum intrauterine contraceptive device (PPIUCD) copper T380A on expulsion rates

Postpartum intrauterine contraceptive device (PPIUCD) is a well accepted concept and was recommended and adopted by the Government of India since 20101. It can be inserted within 10 min of a placental delivery (immediate insertion) or after 10 min and upto 48 h of delivery2.3. However, higher expulsion rates reported with early versus immediate postpartum insertion are of concern4. In a systematic review from 20095, the early group was reported to have higher expulsion rates in comparison to the immediate insertion. However, many of the included studies were heterogeneous including both intra-caesarean and post-vaginal delivery insertion and including various intrauterine devices. Anxiety about the baby condition for the first 24 h may come in the way of whole-hearted acceptance of immediate insertion in spite of antenatal counselling6. The 2015 Cochrane analysis reported limited evidence to conclude on the expulsion rates based on the timing of insertion following vaginal delivery7. Hence, this study was undertaken with the primary objective of comparing the expulsion rates in the immediate and early PPIUCD insertions and furthermore of study to the safety and complications post PPIUCD insertions after vaginal deliveries.

Material & Methods

This prospective comparative study was carried out in department of Obstetrics and Gynecology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, which is a tertiary care teaching hospital located in the south of India. The study was carried out from July 2017 till December 2018 after obtaining approval from the scientific committee and Institute Ethics Committee. There were about 1500 deliveries every month. Intense counselling was undertaken in the antenatal as well as during labour and in the post-natal wards as a part of the study. Women delivering vaginally and were motivated and willing for intrauterine contraceptive device (IUCD) insertion during the puerperal period were included in this study. Women with a prior caesarean scar, chorioamnionitis, prolonged rupture of membranes, postpartum complications and any known uterine malformations were excluded from the study. Intra-caesarean insertions were not included in the study. Based on the timing of insertion, two groups were studied, (i) immediate group: IUCD inserted within 10 min of placental delivery; and (ii) early group: devise inserted between 10 min upto 48 h postpartum. The participants were allocated to either group based on their preference. The device used was copper T 380A (CuT380A) (HLL Lifecare Ltd., Kerala, India).

Assuming alpha error of five per cent, power of 80 per cent, expulsion rate with postpartum insertion as 12 per cent4 and two times higher rates in the delayed postpartum insertion group5, the sample size come upto 160 per group. The device was inserted under aseptic precautions using Kelly’s Placental Forceps. All the insertions were carried out by consultants or post-degree doctors after on-site and on-the-job training. Ultrasound was carried out to confirm the correct placement of the device prior to discharge of every study participant from the hospital. The data were collected in a pro forma, and all the participants were followed up at six weeks and three months.

Statistical analysis: The data were analyzed using IBM SPSS Statistics for Windows version 22.0 (IBM Corp. Armonk, NY, USA). The two groups were compared for expulsion rates and other complications. All categorical variables such as age parity gravida and IUCD expulsion were expressed as percentages with 95 per cent confidence interval. Expulsion rates in the two groups were analyzed using the Chi-square test. P<0.05 was taken as statistically significant. Factors associated with expulsion were also analyzed.

Results

A total of 1550 women were counselled during the antenatal period and/or during labour for considering PIUCD insertion. 320 women (20.6% acceptance rate) accepted the IUCD and completed the study.

More than 85 per cent of the recruited women in either group belonged to Tamil Nadu. They delivered at the study hospital either because their maternal home was in Puducherry or because they sought to deliver there for the quality and free care.

Most of the demographic variables (Table I) were comparable in the two groups. We found that higher income of the husbands was more likely to be associated with early rather than immediate insertion (χ²=9.8015. P=0.002) and women with previous use of contraception were more likely to opt for immediate insertion (χ²=27.28. P=0.001).

In all the 320 cases recruited, the IUCD was inserted with Kelly’s placental forceps. There was no technical issues experienced at the time of inserting the IUCD. However, three in the immediate group and seven in the early group were found to have the IUCD inserted in the lower part of the uterus at the time of check scan. The same was repositioned to the fundus of the uterus.

At six week follow up (Table II), many women did not come for check up, but they responded to phone call. Five in the immediate group and six in the early group expelled the IUCD by six weeks. These women responded to phone call only and were not keen on reinsertion. Pain was the only complaint encountered. In nine women (1 in the immediate and 8 in the early group, out of a total 155 who came for the six week check up), the threads were not seen. They were reassured as the device was confirmed to be intrauterine by sonography. In the immediate group, there were three more expulsions (Table III). These three women were not willing for a reinsertion.

The threads were cut short if these were lower down in the vagina. However, if seen only at level of the cervical os, these were not cut. The threads were seen in all the women at three-month follow up. In one woman, the thread was not seen at six weeks. This was seen at the level of cervix at three month follow up. It was observed that in the immediate group out of 160, there were eight expulsions; 104 women required cutting of thread (80 at 6 wk and another 24 at 3 months) and in 48 women, the thread was seen only at the level of cervix and was never cut.

In the early group out of 160, there were six expulsions. Eighty three women (66 at 6 wk and another 17 at 3 months) required cutting of the threads. The rest of the 71 women did not require cutting of threads as the threads were seen at the cervix only. The threads were not seen in eight women at six weeks in the early group. Five of these eight were at the level of cervix and three low in vagina at three month follow up.

The outcome variable in the two groups is shown in Table IV. There was a total of eight expulsions in the immediate (5%) and six (3.7%) in the early group. There was no case of perforation or excessive bleeding upto the three month follow up period. Ten women in the early and six in the immediate group had pain as the only complaint. None of the women were found to have clinical symptoms or signs of infection. Women in the immediate group were significantly more satisfied (n=155; 96.9%) as compared to those in the early group (n=143, 89.4%). The satisfaction was regarding the subjective feeling of use of IUCD as the method of contraception without any problems and regret (χ²=7.029, P=0.008, 95% CI - 0.87-0.98).

At the end of the three months, all the patients who did not expel the IUCD were motivated to continue the IUCD. None of them requested a removal.

On univariate analysis (Table V), we found that women with lower age, lower parity, lower husband income, motivation to continue and higher satisfaction were less likely to expel the IUCD.

Discussion

In this study, the acceptance rate for PPIUCD was 21.3 per cent as compared to nine to 17 per cent rate of acceptance as observed in other studies8-10. In a six-centre study11, the acceptance rate was found to be only five per cent. In this study intense one-to-one and small group counselling sessions with videos and pamphlets were carried out. Counselling was carried out in the antenatal clinics as also during early labour and in the post-natal period. The reasons for non-acceptance in this study were not explored. In an earlier study from our group, we found that lack of family support, negative attitude and preferring to use natural methods were the causes for lower acceptance12.

In our study, all the insertions were carried out by consultants or qualified trained doctors. All the insertions were based on standard procedure using Kelly’s placental forceps. An overall expulsion rate of 4.4 per cent was found among the study participants. Higher expulsion rates have been described in other studies7,8,13. Expulsion rate varying from 3-7 per cent has been reported over the last few years14-16. In a study published in 2019 on 372 women with mixed population of vaginal and caesarean delivery, the expulsion rate was found to be 4.2 per cent17. The expulsion rate has declined with the standardized method of insertion with the Kelly’s placental forceps and improved training over the years.

In our study, the expulsion rate was marginally higher at five per cent in the immediate (post-placental) group and 3.7 per cent in the early group (beyond 10 min up to 48 h of placental delivery). A higher expulsion rate in the immediate group compared to the early group was also reported in other published observational studies11,18. Only two randomized trials19,20 have compared the expulsion rates of the device CuT380A based on the timing of insertion. In the trial by Ahuja and Rahtore19, 108 women were recruited into the two groups. Similar to our study in this study also, all insertions were with instrument. The authors found that that the expulsion rates were significantly higher at 24.11 per cent in the early (10 min to 48 h group) and 9.11 per cent in the immediate post-placental group. In the trial by Singh et al20, immediate post-placental IUCD insertion (n=100) demonstrated lower expulsion rate of 8.3 per cent compared to 10.5 per cent with early post-partum insertion though it was not found to be significant. In the latter study, caesarean cases were also included. It is not specified in these two trials whether ultrasonography was done after insertion20.

The present study ultrasonography was carried out for all women before discharge from the hospital. Three in the immediate and five in the early group were found to have a low placement of the device. The same were repositioned to the fundus of the uterus. Dias et al21 observed that the distance of lower end of the device from the internal os predicted expulsion with reasonable accuracy. Thus, routine ultrasound in our study helped us pick up eight cases which could have expelled the IUCD if not repositioned.

No case of infection in the present study was found to be similar to other reports8,22. As a policy, no antibiotics were prescribed following PPIUCD insertion. Strict aseptic measures were followed for delivery and no touch technique was followed for loading the device to the Kelly’s forceps.

Univariate analysis showed that lower age, lower parity, higher spousal income, motivation to continue and higher satisfaction were associated with lower risk of expulsion. In a study by Kant et al23 also, higher age and parity was associated with higher expulsion rates.

All these women were found to be normal on pelvic exam and sonography. Abdominal pain was the only complaint but all of them responded to pain killers.

The continuation rate among the women who did not expel was found to be 100 per cent in our study. This may possibly be due to the intense antenatal and post-delivery counselling by a committed team. The limitation of this study is that we designed the groups based on women’s preference. However, randomized would have been the best approach to bring out the differences in expulsion rate based on timing of insertion.

Overall, this study found PPIUCD to be safe with no observed complications of perforation, infection or bleeding. Higher age, higher parity, lower spousal income, lack of satisfaction and motivation to continue were found to be the predictors of expulsion. The findings of this study may only be extrapolated with inclusion of intense counselling in the antenatal clinic and follow up counselling in labour and post-delivery.