IUD Insertion Clinical Trial
Official title:
Vaginal Versus Sublingual Misoprostol Before Intrauterine Device Insertion in Women With Pervious Caesarian Section
Insertion failures of intrauterine devices and cervical problems seem to occur more often among women who have never delivered vaginally. This trial will compare the effect of vaginal versus sublingual misoprostol prior to insertion of an intrauterine device in multiparous women delivered by CS.
Status | Recruiting |
Enrollment | 2 |
Est. completion date | May 25, 2022 |
Est. primary completion date | February 17, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: Women at the reproductive age group between 20-40 years Women who previously delivered by cesarean section. Women with BMI between 20- 30. Exclusion Criteria: Women had a previous vaginal operations. Women with contraindications for misoprostol use (pregnancy, prostaglandin allergy) Women with a contraindication for IUCD insertion (e.g., less than sex weeks post-partum, gynecologic malignancy, uterine bleeding of undetermined origin, fibroids or other uterine abnormalities, active vaginitis or cervicitis, a history of PID or puerperal sepsis). Women on anticoagulant therapy or having any coagulopathy. Women who refused to participate. |
Country | Name | City | State |
---|---|---|---|
Egypt | Ain Shams University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The proportion of easy IUD Insertion | Difficulty of IUD insertion will be measured by cervical dilatation that determined by two factors: Degree of dilatation of cervix by using gradual Hegar 1, 2, 3. The degree of difficulty of the IUD insertion judged as the resistance of the internal cervical os experienced by the investigator and classified as 'easy', 'moderate' or 'difficult'. [Time Frame: Easy: Using Hegar 3 and easy of difficulty of insertion. Moderate: Using Hegar 2 and moderate of difficulty of insertion. Difficult: Using Hegar 1 and difficult of difficulty of insertion] |
24 hours | |
Secondary | the pain during insertion | Pain will be measured using a visual analog scale (VAS) pain score reported by participants during IUD insertion. Pain score will be measured using a visual analogue scale consisting of a 10 cm horizontal straight line on which 0 cm corresponds to no pain and 10 cm to the worst pain. VAS is rated as 0 no pain. 1-3 for mild pain. 4-6 for average pain and 7-9 for severe pain and 10 for extremely sever pain an individual can experience. | 24 hours |
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