NCT03587077

Pain Relief During IUD Insertion in Women Delivered Only by Elective Cesarean Section

Effect of Adding Vaginal Isosorbide Mononitrate to Misoprostol Prior to Intrauterine Device Insertion in Women Delivered Only by Elective Cesarean Section: a Randomized Double-blind Controlled Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 113 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The aim of the work is to assess the effect of combined misoprostol 200 mcg and isosorbide mononitrate 40 mg versus misoprostol 200 mcg and placebo as local vaginal tablet on the successful IUD insertion.

Detailed description

Fear of pain during insertion of an IUD may deter women from choosing the IUD as a method of contraception. According to Hubacher et al. predictors of increased pain during IUD insertion include nulliparity, age greater than 30 years, lengthier time since last pregnancy or last menses, and not currently breastfeeding. Allen et al. predicted pain to be greater based on history of no previous vaginal delivery, and difficulty of the procedure. Pharmacological interventions for pain control during IUD insertion include analgesics, local anesthetics, and the use of prostaglandins to soften the cervix; however, there is wide variation in the use of these methods . Misoprostol has also been proposed as an agent to ease IUD insertion and decrease procedure-associated pain . Nitrous oxide has been used for years for procedural analgesia in outpatient settings and has recently been investigated as an approach to pain management in the context of IUD insertion . Sewell and Vincent have been offering nitrous oxide for reducing the pain of IUD insertion and have had a positive response.

Conditions

• IUD Insertion Complication

Interventions

Type	Name	Description
DRUG	Misoprostol	vaginal application
DRUG	Placebos	vaginal application
DRUG	isosorbide mononitrate	vaginal application

Timeline

• Start date: 2018-09-01
• Primary completion: 2019-04-01
• Completion: 2019-05-01
• First posted: 2018-07-16
• Last updated: 2018-07-16