Materials and Methods
This prospective study was conducted in the Department of Obstetrics and Gynaecology, College of Medicine and JNM Hospital, Kalyani (West Bengal) from 3rd August 2017 to 2nd June 2018. The data was collected from 3rd September to 2nd December 2017 and then analysed. The study was approved by the ethics committee of the Institution (ref. no. F-24/PR/COMJNMH/IEC/17/1310).
All pregnant women who were admitted to undergo vaginal or caesarean delivery, had given written consent for Cu-T 380A insertion and agreed for a follow-up upto three months were included in the study. Exclusion criteria were unresolved PPH, acute purulent discharge, PROM >18 hours, chorioamnionitis, any congenital malformation of the uterus, large fibroid, etc.
All women irrespective of maternal age, risk factor and proposed mode of delivery at the antenatal clinic of the institution were counselled about contraceptive options. First 127 mothers who delivered vaginally and the first 127 mothers who underwent caesarean section were regarded as study groups and were followed up for three months. The sample size was calculated by using the reference of scientific tables 7th edition Geigy 1970, p28 and the minimum sample required to conduct the study was found to be 127. Therefore we have taken 127 as our sample size in each group.
Cu-T 380A was inserted within 10 minutes of placental expulsion in vaginal deliveries and during caesarean section. Post placental insertion of Cu-T 380A in vaginal delivery was done by using Kelly’s Forceps. IUCD was held suitably with a long forceps without a lock. The instrument was inserted up to the fundus of the uterus and the IUCD was released. Intracaesarean PPIUCD was done by holding the IUCD between the middle and index fingers of the hand and pass it through the uterine incision. After placing it at the fundus of the uterus, the hand was withdrawn taking care that the IUCD remains properly placed.
Any possible complication in the immediate post-partum period attributable to the PPIUCD was noted. Counselling was done in the maternity ward before discharge regarding complications that can occur like expulsion, bleeding, abdominal pain and infection, etc. A follow-up plan at six weeks and three months after discharge from the hospital was explained to the patients. Both the study groups were compared based on study variables included in this study like expulsion of CuT, missing string etc. by clinical examination and ultrasonography. Socioeconomic status classification was done by standard Kuppuswamy classification. At the end of three month we compared the incidence of different complications among groups e.g., bleeding, pain, infection, perforation and client satisfaction. Client satisfaction was assessed after three months using visual analogue scale. Maximum satisfaction was given a scale of 5 and the least satisfaction was given a scale of 1. Mothers who did not come for clinical follow-up was called up by telephone calls to the number provided during admission for follow-up examination at OPD.
Results
During the data collection period 2287 women were counselled during the antenatal visit, after admission to the hospital and in the immediate post-partum period. Overall 1345 patients (799 cases in c/s group and 546 cases in vaginal delivery group) had PPIUCD insertion in the study period. Acceptance rate was 58.81% [Table/Fig-1].
Acceptance of post-partum IUCD among mothers after counseling.
| Month | No. of mother counselled | No. of mother accepted | Acceptance rate (%) |
|---|
| September 2017 | 761 | 443 | 58.2 |
| October 2017 | 805 | 475 | 59 |
| November-Dec 2nd 2017 | 721 | 427 | 59.2 |
| Total | 2287 | 1345 | 58.8 |
First 127 mothers who delivered vaginally and the first 127 who underwent caesarean section were regarded as study groups and were followed up for three months. The study subjects were compared with respect to their demographic parameters [Table/Fig-2].
Demographic parameters comparison of the two groups.
| Parameters | Caesarean section | Vaginal delivery | Significance (p≤0.05) |
|---|
| Age (mean±SD) | 25.1 (±4.34) | 23.6 (±3.85) | 0.27 |
| Parity 1N (%) | 65 (51%) | 74 (58%) | 0.41 |
| 2 | 50 (39%) | 43 (34%) | 0.62 |
| 3 | 9 (7%) | 8 (6%) | 0.93 |
| 4 | 1 (0.8%) | 1 (0.8%) | |
| 5 | 1 (0.8%) | 1 (0.8%) | |
| 6 | 1 (0.8%) | 0 | |
| Socioeconomic status Upper middle | 2 (2%) | 4 (3%) | 0.689 |
| Lower middle | 19 (15%) | 19 (15%) | 1 |
| Upper lower | 69 (54%) | 74 (59%) | 0.393 |
| Lower | 37 (29%) | 30 (23%) | 0.428 |
Different complications and patient’s satisfaction using visual analogue scale was also compared [Table/Fig-3].
Comparison of complications between two groups.
| Parameter | Intracaesarean group | Vaginal delivery group | Significance (p≤0.05) |
|---|
| Expulsion of cu-T at 6 weeks | 1 (0.8%) | 5 (3.9%) | 0.09 |
| Expulsion rate at 3 months | 4 (3.1%) | 6 (4.7%) | 0.51 |
| Missing string at 6 weeks | 50 (39.3%) | 44 (34.6%) | 0.51 |
| Missing string at 3 months | 50 (39.3%) | 34 (26.9%) | 0.04 |
| Vaginal bleeding (At 3 months) | 5 (3.9%) | 6 (4.7%) | 0.74 |
| Pelvic pain (At 3 months) | 8 (6.2%) | 9 (7.1%) | 0.78 |
| Vaginal discharge (At 3 months) | 6 (4.7%) | 4 (3.9%) | 0.75 |
| Score 3 in VAS | 61.4 | 62.7 | |
Discussion
In present study we found acceptance rate to be 58.81% which is quite high. Kharkwal S et al., also found acceptance rate of PPIUCD to be 60% [3] whereas, Kanhere AV et al., found acceptance rate of PPIUCD insertion to be 36% [4]. As the nurses of our maternity ward were also given training, they contributed to the increase in post placental insertions and hence training of staff is essential. In a 5 year study conducted by Shukla M et al., in 2012 in a tertiary care centre in north India, the PPIUCD acceptors were between 22-30 years of age, 31.66% were primiparas and 68.33% were multiparas [5]. This was in contrast to present study where most PPIUCD acceptors were primiparas. It is evident that in a study where multipara acceptors were common, PPIUCD was an alternative to permanent sterilisation whereas in this study birth spacing was the intention. Economically the majority of the acceptors in this study were women belonging to upper lower class that had no knowledge about the benefits of PPIUCD but accepted it after proper counselling was done in antenatal clinic. 99.2% women who had insertion after vaginal delivery and 100% women with intracaesarean insertion reported for follow-up at six weeks. Subsequently, same percent of follow-up presented at three months. In the north Indian series by Shukla M et al., 78.7% came for the first follow-up at six weeks but incidence fell to 11.37% at six months [5]. The cumulative expulsion rates in intracaesarean and post vaginal delivery groups were 3.9% and 8.6% respectively. As a whole expulsion rate of PPIUCD was 6.3% in this study. A cohort study from China by Chi Zhou SW et al., found significantly lower expulsion rate of PPIUCD in caesarean section group than after vaginal delivery [6]. A study in Mexico investigated 157 insertions after caesarean section Vis a Vis post vaginal deliveries. After one year expulsion rates were 9% and 13% in the two groups respectively. Missing thread was a common complaint particularly in caesarean delivery group. The rate was 39.3% in intracaesarean insertion versus 34.6% in post vaginal delivery at six weeks and 39.3% in intracaesarean and 26.9% in post vaginal delivery at three months follow-up. At three months follow-up the difference between the two groups was statistically significant (p-value-0.04). In the study by Shukla M et al., rate of missing thread was 11.2% at six weeks 10.1% at six months [5].
The present study revealed low rate of complication viz., bleeding, pain and infection to the tune of 4.7%, 7.1% and 3.9% respectively with post placental insertion; however, in caesarean delivery group 3.9%, 6.2%, and 4.7% respectively. Moreover, when the complications compared between the two groups the difference was not statistically significant (p>0.05). None of their uterus got perforated during the procedure of insertion in both groups. No mother in each group became pregnant during follow-up period of three months. However, further long term follow-up is essential. Hooda R et al., also found no case of pregnancy and perforation [7]. For degrees of satisfaction majority gave a score of 3 which meant that the method was acceptable to the users. A 7.1% of intracaesarean acceptors and of 2.4% post vaginal delivery acceptors were totally dissatisfied with this type of contraception.
Limitation
The present study was limited by its small sample size and short period of follow-up. Therefore, based on this study results it is hard to comment on the occurrence of uncommon complications like perforation of uterus and pregnancy rate in both the groups of PPIUCD use. A study with more number of subjects and long term follow-up would better address those issues.
Conclusion
Counseling increases the acceptance of PPIUCD. Education played a pivotal role in the acceptance of PPIUCD. Missing string is a common problem following PPIUCD Cu-T 380A insertion in intracaesarean mothers as compared to post vaginal delivery mothers. Visibility of string progressively increased with passage of time. Expulsion rate was found to be low during the follow-up period. Present study noted 100% contraception efficacy of the PPIUCD though follow-up was for three months only. With proper insertion techniques expulsion rate can be kept low. None of mother had perforation of uterus during study period. Client satisfaction rate is comparable in both the groups of PPIUCD acceptors. This study suggests that immediate post placental insertion of IUCD is a convenient opportunity which should not be missed in countries like ours with high rates of unplanned and short interval pregnancies in women with limited exposure to health care providers.