NCT04045548

Brief Summary

To investigate whether vaginal dinoprostone administered before the levonorgestrel-releasing intrauterine system(IUs) insertion reduces failed insertions, insertion-related complications, and pain in Women With no Previous Vaginal Delivery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 5, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

August 10, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2020

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

5 months

First QC Date

August 2, 2019

Last Update Submit

January 9, 2020

Conditions

Intrauterine Device

Outcome Measures

Primary Outcomes (1)

  • The difference in pain scores during intrauterine device insertion

    The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10

    10 minutes

Study Arms (2)

dinoprostone

EXPERIMENTAL

1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the study nurse 2 hours before IUD insertion.

Drug: Dinoprostone

placebo

PLACEBO COMPARATOR

one tablet of placebo inserted by the study nurse 2 hours before IUD insertion.

Drug: Placebo

Interventions

DinoprostoneDRUG

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

dinoprostone
PlaceboDRUG

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

placebo

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Non-pregnant women
  • Women that did not receive any analgesics or Dinoprostone in the 24 hours prior to insertion
  • Women who delivered only by cesarean section

You may not qualify if:

  • Women with any uterine abnormalities as congenital anomalies, endometrial lesions, adenomyosis, fibroids.
  • Those with a Category 3 or 4 conditions for intrauterine device insertion according to the WHO Medical Eligibility Criteria for contraceptive use
  • Allergy to dinoprostone.
  • Women refuse to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of medicine Cairo university

Cairo, 11231, Egypt

Location

MeSH Terms

Interventions

Dinoprostone

Intervention Hierarchy (Ancestors)

Prostaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological 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 2, 2019

First Posted

August 5, 2019

Study Start

August 10, 2019

Primary Completion

January 1, 2020

Study Completion

January 5, 2020

Last Updated

January 13, 2020

Record last verified: 2020-01

Locations

EG(1)