Vaginal Dinoprostone Administration Prior to a T380A Intrauterine Device Insertion in Nulliparous Women.

NCT03686085 | Completed Phase 3

• 1 other identifier: vaginal dinoprostone nullipara
• Study Type: interventional
• Target: 200
• 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 nulliparous women.

Conditions

Intrauterine Device

Outcome Measures

Primary Outcomes (1)

• Provider ease of insertion

  Provider ease of insertion was evaluated using a visual analog scale from 0 to 10 cm where 0 denotes very easy insertion and 10 denotes a very difficult insertion.

  5 minutes

Secondary Outcomes (2)

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

  5 minutes

• insertion time

  10 minutes

Study Arms (2)

dinoprostone arm

EXPERIMENTAL

1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the study nurse 6 hours before IUD insertion.

Drug: Dinoprostone 3 mg

placebo

PLACEBO COMPARATOR

one tablet of placebo inserted by the study nurse 6 hours before IUD insertion.

Drug: placebo vaginal tablet

Interventions

Dinoprostone 3 mg DRUG

1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the study nurse 6 hours before IUD insertion.

dinoprostone arm

placebo vaginal tablet DRUG

1 vaginal tablet of placebo inserted by the study nurse 6 hours before IUD insertion.

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• a prior pregnancy greater than 20 weeks of duration
• 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 to dinoprostone.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine Cairo University

Giza, 11231, Egypt

Location

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, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer in obstetrics and gynecology

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: September 26, 2018
• Study Start: September 30, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 10, 2019
• Last Updated: June 30, 2020

Record last verified: 2020-06

Locations

EG (1)