Effectiveness, safety, and acceptability of post-placental insertion of
GyneFix postpartum intrauterine device among women undergoing cesarean
section: A multicenter prospective cohort study in China
Abstract
Objective To assess the effectiveness, safety, and acceptability of
post-placental insertion of GyneFix postpartum intrauterine device
(PPIUD) in women undergoing cesarean section (C-section). Design
Prospective cohort study. Setting Fourteen hospitals in four provinces
of China. Population and sample Women who underwent C-section and
consented to the post-placental insertion of GyneFix PPIUD. We enrolled
470 participants, and 400 completed the 12-month follow-up. Methods
Participants were interviewed in the wards after delivery and followed
up at 42 days, and months 3, 6, and 12 after delivery. Main outcome
measures Pregnancy, PPIUD expulsion, serious adverse events, and
continuation of PPIUD. Results Nine pregnancies were detected during the
first year after GytneFix PPIUD insertion, 7 were due to device
expulsion and 2 occurred with PPIUD in situ. The Pearl Indices (PI;
pregnancy per 100 women-years) for overall 1-year pregnancy rate and
pregnancies with IUD in situ were 2.32 (95% CI: 1.06–4.40) and 0.51
(95% CI: 0.06–1.86), respectively. The 1-year expulsion PI was 8.25
(95% CI: 5.63–11.63). The expulsion PI was significantly higher in the
first 6 months (12.78, 95% CI: 8.42–18.60) than the second 6 months
(2.82, 95% CI: 0.92–6.58). The cumulative 1-year continuation rate was
86.56% (95% CI: 83.32–89.79). We did not identify any patient with
insertion failure, uterine perforation, pelvic infection, or excess
bleeding due to GyneFix PPIUD insertion. Conclusions Post-placental
insertion of GyneFix PPIUD is effective, safe, and acceptable for women
undergoing C-section. An ultrasound scan during the first 6 months after
PPIUD insertion is recommended to identify any unrecognized expulsions.