Intra-uterine Device Complication Clinical Trial
Official title:
Efficacy and Safety of Different Doses of Vaginal Misoprostol Prior to Intra Uterine Contraceptive Device Insertion
Verified date | July 2020 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
investigators aim through this study to evaluate and compare the Safety and efficacy of different doses of misoprostol prior to IUCD insertion among women with nulliparous cervix beside the rate of occurrence of adverse effects.
Status | Completed |
Enrollment | 180 |
Est. completion date | June 30, 2020 |
Est. primary completion date | June 15, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Non-pregnant, - Nulliparous cervix: no previous vaginal delivery or any attempt of vaginal delivery, - Seeking for IUD insertion, - Signing an informed consent to participate in the study, Exclusion Criteria: - Pregnancy or signs of pregnancy, - Signs of cervicitis, - Any uterine abnormalities as congenital anomalies, endometrial lesions, adenomyosis, fibroids and intrauterine adhesions, - Women with any kind of pelvic pain, - Abnormal uterine bleeding, - History of cervical surgery,• Vaginal delivery, - Contraindication to misoprostol as allergy, - Administration of any analgesics last 12h, - Withdrawal of consent |
Country | Name | City | State |
---|---|---|---|
Egypt | Ain Shams University Maternity Hospital | Cairo | |
Egypt | Misr University for Science & Technology | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
Abbas AM, Abdellah MS, Khalaf M, Bahloul M, Abdellah NH, Ali MK, Abdelmagied AM. Effect of cervical lidocaine-prilocaine cream on pain perception during copper T380A intrauterine device insertion among parous women: A randomized double-blind controlled trial. Contraception. 2017 Mar;95(3):251-256. doi: 10.1016/j.contraception.2016.10.011. Epub 2016 Nov 4. — View Citation
Abdellah MS, Abbas AM, Hegazy AM, El-Nashar IM. Vaginal misoprostol prior to intrauterine device insertion in women delivered only by elective cesarean section: a randomized double-blind clinical trial. Contraception. 2017 Jun;95(6):538-543. doi: 10.1016/j.contraception.2017.01.003. Epub 2017 Jan 11. — View Citation
Aronsson A, Fiala C, Stephansson O, Granath F, Watzer B, Schweer H, Gemzell-Danielsson K. Pharmacokinetic profiles up to 12 h after administration of vaginal, sublingual and slow-release oral misoprostol. Hum Reprod. 2007 Jul;22(7):1912-8. Epub 2007 May 8. — View Citation
Bahamondes MV, Espejo-Arce X, Bahamondes L. Effect of vaginal administration of misoprostol before intrauterine contraceptive insertion following previous insertion failure: a double blind RCT. Hum Reprod. 2015 Aug;30(8):1861-6. doi: 10.1093/humrep/dev137. Epub 2015 Jun 3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The side effects of the study medication | as shivering, nausea, vomiting and diarrhea | within 3 hours from inserting the misoprostol tablet | |
Other | Complications from IUD insertion | as abdominal cramps, uterine bleeding, perforation and cervical trauma | during insertion ofIUCD | |
Other | The number of women who need additional analgesics after the insertion | 5 minutes after insertion | ||
Other | Failure of IUD insertion, due to technical difficulty or intolerance of the patient | during IUCD insertion | ||
Primary | Pain scores | Pain scores will be measured using a visual analogue scale (VAS) consisting of a 10 cm horizontal straight line on which 0 cm corresponded to no pain and 10 cm to the worst pain. The pain score will be measured within 5 min of insertion of the IUD tube. | during insertion of IUCD | |
Secondary | The ease of IUD insertion | The ease of IUD insertion: using the ease of insertion score (ES): a graduated VAS-like scale from 0 to 10; in which 10 means terribly difficult insertion and 0 means very easy insertion. The ES was validated for use in previous similar studies about IUD insertion (Abbas et al., 2017). | during insertion ofIUCD | |
Secondary | Successful IUD insertion | Successful IUD insertion which will be assessed by vaginal US device 'Samsung h 60' through the following criteria: IUD is centrally located within the endometrial cavity The crossbar is positioned in the fundal area. The distance from the top of the uterine cavity to the IUD should be 3 mm or less. This ultrasound scan will be performed just after the IUCD insertion. |
5minutes after insertion of IUCD | |
Secondary | The duration of insertion in seconds | The duration of insertion in seconds: starting from putting loaded applicator at the external os till withdrawal of the applicator after IUD insertion | during insertion ofIUCD | |
Secondary | The women's level of satisfaction at the end of insertion | The women's level of satisfaction at the end of insertion: every woman will express her level of satisfaction with IUD insertion by completing a 10-cm VAS (with 0 = no satisfaction and 10 = maximum satisfaction). |
1 miute after insertion of IUCD |
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