Background Intrauterine adhesions (IUAs) are reported after dilatation and curettage (D&C) for miscarriage, with frequency related to number of procedures. IUAs are associated with menstrual disturbances, infertility and obstetric complications. In the PAPA-study we aimed to investigate whether application of auto-crosslinked hyaluronic acid (ACP) gel following D&C for miscarriage reduces the rate and severity of IUAs. Methods We performed a multicentre, open-label, randomised controlled study in one university and seven affiliated hospitals in the Netherlands. Women planned for a D&C for miscarriage, with at least one previous D&C, were randomly assigned (1:1) to either D&C plus intrauterine application of ACP gel (10 ml) immediately after the procedure (intervention group) or D&C alone (control group). Randomisation was done with a web-based concealed allocation and stratified by centre with variable block sizes. Each woman underwent a follow-up hysteroscopy 8-12 weeks after the D&C-procedure. The primary outcome was the amount and severity of IUAs. Results Between December 16, 2011 till April 22, 2015, we randomly assigned 78 women to the intervention group and 74 to the control group. Sixty (78%) of 77 women eligible for assessment in the intervention group and 58 (81%) of 72 women in the control group underwent a hysteroscopy. IUAs were observed in 10 (13%) women in the intervention group compared to 22 (31%) women in the control group (relative risk [RR] 0.43; 95% CI 0.22 to 0.83). The severity of the IUAs and mean adhesion score was significantly lower in the intervention group. Conclusions Application of ACP gel following D&C for miscarriage in women with at least one previous D&C, significantly reduces the incidence and severity of IUAs. Adhesion prevention should be offered to this specific group.
|Publication status||Published - 2016|