IUD Insertion Complication
Conditions
Brief 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.
Interventions
DRUGMisoprostol
vaginal application
DRUGPlacebos
vaginal application
vaginal application
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
We will include * Nonpregnant women, * aged 18-45 years, .delivered before only by elective CS and did not receive any analgesics in the 24 h prior to IUD insertion.
Exclusion criteria
We will exclude * Women with any uterine abnormalities as congenital anomalies, * Women with endometrial lesions, * Women with adenomyosis, * Women with fibroids, * Women with intrauterine adhesions, * Women with chronic pelvic pain, * Women with spasmodic dysmenorrhea, * Women with abnormal uterine bleeding, * Women with history of cervical surgery, .Women with allergy to misoprostol or isosorbide mononitrate or any medical disease that contraindicates its use and those who refused to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rate of successful IUD insertion | 10 minutes | Defined by a distance from the IUD to the endometrial end of less than 25 mm |
Contacts
Primary ContactEman I. Ramadan, BSc
Outcome results
None listed