Efficacy and Safety of Different Doses of Vaginal Misoprostol Prior to Intra Uterine Contraceptive Device Insertion

NCT04273984 | Completed Phase 4

• 1 other identifier: Misoprostol Prior to IUCD
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Intra-uterine Device Complication

Keywords

misoprostol; IUCD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The ease of IUD insertion

  during insertion ofIUCD

• Successful IUD insertion

  5minutes after insertion of IUCD

• The duration of insertion in seconds

  during insertion ofIUCD

• The women's level of satisfaction at the end of insertion

  1 miute after insertion of IUCD

Other Outcomes (4)

• The side effects of the study medication

  within 3 hours from inserting the misoprostol tablet

• Complications from IUD insertion

  during insertion ofIUCD

• The number of women who need additional analgesics after the insertion

  5 minutes after insertion

Study Arms (3)

1- Group 1 (misoprostol 200 mcg

ACTIVE COMPARATOR

Group 1 :will take 1 tablet (200 mcg) of misoprostol and 1 placebo tablet, .,

Drug: Misoprostol

2- Group 2 (misoprostol 100 mcg)

ACTIVE COMPARATOR

Group 2: will take1 tablet (100 mcg) of misoprostol and 1 placebo tablet,

Drug: Misoprostol

3- Group 3 (placebo group)

PLACEBO COMPARATOR

Group 3 ): will take2 placebo tablets

Drug: Misoprostol

Interventions

Misoprostol DRUG

Tablets will be inserted digitally by an experienced gynecologist 3hours before IUD insertion with taking care not inserting the medication into the cervix.

Also known as: misotac

1- Group 1 (misoprostol 200 mcg; 2- Group 2 (misoprostol 100 mcg); 3- Group 3 (placebo group)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (2)

Ain Shams University Maternity Hospital

Cairo, Egypt

Location

Misr University for Science & Technology

Cairo, Egypt

Location

Related Publications (4)

• 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.

  PMID: 27823944 BACKGROUND

• 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.

  PMID: 28088498 BACKGROUND

• 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. doi: 10.1093/humrep/dem098. Epub 2007 May 8.

  PMID: 17488782 BACKGROUND

• 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.

  PMID: 26040478 BACKGROUND

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Mohamed h Salama, MD.MRCOG

  Ainshams uinversity

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 18, 2020
• Study Start: March 1, 2020
• Primary Completion: June 15, 2020
• Study Completion: June 30, 2020
• Last Updated: July 14, 2020

Record last verified: 2020-07

Locations

EG (2)