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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
IUD Insertion Complication

Intervention / Treatment
-----------------
* Drug: Misoprostol
* Drug: Placebos
* Drug: isosorbide mononitrate


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>Women will receive vaginally one tablet misoprostol 200 mcg(Misotac; Sigma Pharma, SAE, EGYPT) plus one tablet isosorbide mononitrate 40 mg(Effox 40 mg; Minapharm). A trained clinical nurse will introduce the tablets, digitally without using speculum, 3 hours before IUD insertion into the posterior vaginal fornix of the woman while lying in the lithotomy position. | Drug: Misoprostol<br>* vaginal application<br>Drug: isosorbide mononitrate<br>* vaginal application<br>|
| Placebo Comparator: control group<br>Women will receive vaginally one tablet misoprostol 200 mcg Plus one tablet placebo.A trained clinical nurse will introduce the tablets, digitally without using speculum, 3 hours before IUD insertion into the posterior vaginal fornix of the woman while lying in the lithotomy position. | Drug: Misoprostol<br>* vaginal application<br>Drug: Placebos<br>* vaginal application<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of successful IUD insertion | Defined by a distance from the IUD to the endometrial end of less than 25 mm | 10 minutes |