Vaginal misoprostol prior to insertion of an intrauterine device

an RCT

Dijkhuizen, Kirsten
Dekkers, Olaf M.
Holleboom, Cas A.G.
de Groot, Christianne J.M.
Hellebrekers, Bart W.J.
van Roosmalen, Godelieve J.J.
Janssen, Catharina A.H.
Helmerhorst, Frans M.

¹Department of Gynaecology, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands
²Department of Clinical Epidemiology, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands
³Department of Gynaecology, Bronovo Hospital, PO Box 96900, 2509 JH, The Hague, The Netherlands
⁴Department of Gynaecology, Medical Centre of the Haaglanden, PO Box 432, 2501 CK, The Hague, The Netherlands
⁵Department of Gynaecology, HAGA Teaching Hospital, PO Box 40551, 2540 LN, The Hague, The Netherlands
⁶Department of Gynaecology, Groene Hart Hospital, PO Box 1098, 2800 BB, Gouda, The Netherlands

Correspondence address. E-mail: [email protected]

Received June 30, 2010

Accepted November 15, 2010

Human Reproduction 26(2):p 323-329, February 2011. | DOI: 10.1093/humrep/deq348

BACKGROUND

Misoprostol is an agent that may ripen the cervix in nonpregnant women. Here, we investigate whether vaginal misoprostol administered prior to intrauterine device (IUD) insertion reduces the number of failed insertions, insertion-related complications and pain during insertion.

METHODS

We conducted a double-blinded, multicenter randomized controlled trial among patients requesting an IUD. Nulli- and multi-parous women were included, and both copper-containing and levonorgestrel-releasing IUDs were used. Participants were allocated to either 400 μg misoprostol or placebo (administered 3h prior to IUD insertion). The primary outcome measure was failed insertion. Secondary outcome measures were insertion-related complications, pain, difficulty of insertion and side-effects.

RESULTS

Two hundred and seventy participants were randomized. After drop out for various reasons (mainly no show), 199 participants had an IUD inserted; 102 received misoprostol and 97 received placebo. Only three insertions failed; two in the misoprostol group and one in the placebo group [P = 0.59, relative risk (RR) 1.9, 95% confidence interval (CI) 0.2–20.6]. The overall incidence of insertion-related complications was 21.8% in the misoprostol versus 19.1% in the placebo group (mainly vasovagal-like reactions) and did not differ between groups (P = 0.65, RR 1.1, 95% CI 0.7–2.0). No difference in pain scores between groups was found. Side-effects were more common in the misoprostol group (P = 0.05, RR 1.3, 95% CI 1.0–1.7).

CONCLUSION

The study showed no benefit for use of misoprostol prior to IUD insertion. However, there is a tendency of possible harm regarding side-effects. Therefore, we would not recommend standard pretreatment with misoprostol.

The trial was registered in the European Clinical Trials Database EudraCT 2006-006897-60.