Does change in the shape of intrauterine contraceptive device Cu 375 and Cu T 380A affect the expulsion after post-partum insertion – a prospective randomized control trial

Abstract

Purpose

The objective of the study was to see the difference in expulsion rates of two types of Copper containing intrauterine contraceptive devices (IUCDs): Cu 375 & CuT 380 A, within or at 6 weeks after insertion.

Methods

It was a randomised control trial. A total of 396 pregnant women were recruited. Ultrasonography was done to look for the position of the IUCD at the time of discharge and at six weeks follow-up and the expulsion rate was calculated.

Results

Amongst 396 participants, 22 PPIUCDs were expelled completely at 6 weeks (modified intention to treat analysis [ITA]), 10 (5.3%) and 12 (6.7%) in the Cu 375 and CuT 380 A groups respectively. The expulsion rate was 6.02%. However, this difference was not statistically significant. When ultrasonologically assessed partial expulsions were also considered, the total expulsion rate in both groups (14.3% and 14.1% respectively) was also not significantly different. The expulsion rate was higher in the vaginal delivery group (10.7%) than in the caesarean section (3.6%) group (p = 0.007) and early postpartum insertion 12.3% than in the immediate post-placental insertion group, 3.7% (p = 0.002).

Conclusions

The study concluded that the altered shape of Cu 375 has effectively no role in decreasing the expulsion rate. Placement of IUCD at or near the uterine fundus immediately after delivering the placenta (post-placental) decreases the expulsion rate, thereby increasing the contraceptive efficacy.

SHORT CONDENSATION

• The altered shape of Cu 375 has effectively no role in decreasing the expulsion rate. Placement of IUCD at or near the uterine fundus immediately after delivering the placenta (post-placental) decreases the expulsion rate, thereby increasing the contraceptive efficacy.

摘要

目的：本研究的目的是观察两种含铜宫内节育器（IUCDs）：Cu 375和CuT 380A在放置后6周内或在放置后6周的排出率的差异。

方法：这是一项随机对照试验。总共招募了396名孕妇。出院时及放置6周时随访行B超检查IUCD位置, 并计算排出率。

结果：在396名参与者中, 22名PPIUCDs在6周时完全排出（改良意向治疗分析[ITA]）, Cu 375组和CuT 380A组分别为10（5.3%）和12（6.7%）。排出率为6.02%。然而, 这种差异统计学上不显著。当考虑到超声评估的部分排出率时, 两组的总排出率（分别为14.3%和14.1%）也没有显著差异。阴道分娩组的排出率（10.7%）高于剖宫产组（3.6%）（p=0.007）, 产后早期放置组的排出率（12.3%）高于胎盘娩出后即刻放置组的3.7%（p=0.002）。

结论：研究得出结论, 改变形状的Cu 375实际上对降低排出率没有任何作用。分娩胎盘后立即将IUCD放置在宫底或宫底附近（胎盘后）可降低排出率, 从而提高避孕效果。

简短总结

改变形状的Cu375对降低排出率没有明显作用。在胎盘娩出后（胎盘后）后立即放置IUCD在宫底或宫底附近可降低排出率, 从而提高避孕效果。

Keywords:

• Continuation rate
• early postpartum insertion
• endo-myometrial distance
• partial expulsion
• ultrasound

Author contributions

NC and CS researched literature and conceived the study. SS, PS, MG, and MJ were involved in protocol development, gaining ethical approval, patient recruitment and data analysis. MKG was involved in statistical analysis. NC and CS wrote the first draft of the manuscript. All authors reviewed and edited the manuscript and approved the final version of the manuscript

Disclosure statement

No potential conflict of interest was reported by the author(s).

Data availability statement

The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Code availability

SPSS software version 23 was used. Coding Key can be obtained from the corresponding author if required