Vaginal Dinoprostone Administration Prior to an Intrauterine Device Insertion in Multiparous Women.

NCT04046302 | Completed Phase 4

• 1 other identifier: dinoprostone IUD pain
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate whether vaginal dinoprostone administered before intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications, and pain in multiparous women.

Conditions

IUD Insertion

Outcome Measures

Primary Outcomes (1)

• the difference in the pain intensity scores between the study groups

  the difference in the pain intensity scores between the study groups by visual analog scale score which ranges from zero to 10.where zero represents no pain and 10 represents the most worst pain

  5 minutes

Study Arms (2)

dinoprostone

EXPERIMENTAL

1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) self-inserted by the patients 3 hours before the scheduled IUD insertion appointment.

Drug: Dinoprostone

placebo

PLACEBO COMPARATOR

one tablet of placebo self-inserted by the patients 3 hours before the scheduled IUD insertion appointment.

Drug: placebo

Interventions

Dinoprostone DRUG

1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) self-inserted by participants 3 hours before scheduled IUD insertion appointment.

dinoprostone

placebo DRUG

one tablet of placebo self-inserted by participants 3 hours before scheduled IUD insertion appointment.

placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• multiparous women aged over 18 years of age requesting an IUD for contraception, had a negative pregnancy test.

You may not qualify if:

• currently pregnant or were pregnant within 6 weeks of study entry
• had a prior attempted or successful IUD insertion
• had a history of a cervical procedure such as cone biopsy, Loop electrosurgical excision procedure, or cryotherapy
• any World Health Organization Medical Eligibility Criteria category 3 or 4 precaution to an IUD
• active vaginitis or cervicitis
• undiagnosed abnormal uterine bleeding
• pelvic inflammatory disease within the last 3 months
• fibroids or other uterine abnormalities distorting the uterine cavity
• contraindication or allergy to dinoprostone.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

faculty of medicine Cairo university

Giza, 11231, Egypt

Location

Related Publications (1)

• Ashour AS, Nabil H, Yosif MF, Hussein M, Mageed A Allah AA, Mahmoud M, Abdou H, Kholaif K, Mohamed Kotb MM, El Sharkawy M, Abdelhakim AM, Ali AS, Nassar SA, Abbassy AH, Ghamry NK, Abdel-Latif AA, Taher A, El Mahy M. Effect of self-administered vaginal dinoprostone on pain perception during copper intrauterine device insertion in parous women: a randomized controlled trial. Fertil Steril. 2020 Oct;114(4):861-868. doi: 10.1016/j.fertnstert.2020.05.004. Epub 2020 Jul 28.

  PMID: 32732105 DERIVED

MeSH Terms

Interventions

Dinoprostone

Intervention Hierarchy (Ancestors)

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

Study Officials

• AHMED SAMY

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: August 4, 2019
• First Posted: August 6, 2019
• Study Start: August 30, 2019
• Primary Completion: January 10, 2020
• Study Completion: January 30, 2020
• Last Updated: March 10, 2020

Record last verified: 2020-03

Locations

EG (1)