Misoprostol Prior to Intrauterine Device Insertion

Assiut University

Status: Completed

Conditions: IUD

Treatments: Device: IUD; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT04932382

MISO-IUD

Details and patient eligibility

About

The intrauterine device (IUD) is a reliable, safe, long acting, and effective contraceptive method . In spite of that, the pain associated with IUD insertion can be a cause against its insertion. Many researches have been conducted aiming to decrease the degree of pain during IUD insertion; these studies included medical and also technical methods.

The physicians usually prefer to insert the IUD during women's menses because the women are very unlikely to be pregnant and the insertion is easier and the pain is lower The easiness of IUD insertion is a very important issue that can increase women's satisfaction and decrease insertion pain.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women aged 18-45 years
• Non-pregnant women
• Women who will come when there are non-menstruating.

Exclusion criteria

• Women received any analgesics or misoprostol in the 24 hours prior to insertion
• Women with any contraindications for IUD insertion
• Nulliparous women
• Women refuse to participate.
• Women have any contraindication of misoprostol.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Misoprostol group

Other group

Description:

400 µg misoprostol vaginally ; these tablets will be introduced by the principal investigator, digitally without using speculum, 3 hours before IUD insertion into the posterior vaginal fornix of the woman while lying in the lithotomy position

Treatment:

Drug: Misoprostol

Device: IUD

No misoprostol group

Other group

Description:

will not receive any pre-insertion medications.

Treatment:

Device: IUD