NCT04080336

Brief Summary

To compare the effect of vaginal dinoprostone versus vaginal misoprostol administered before the copper intrauterine device(IUD) insertion in reducing IUD inertion pain and the difficulty in inserting the IUD in nulliparous women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 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

September 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

September 10, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2020

Completed
Last Updated

June 30, 2020

Status Verified

June 1, 2020

Enrollment Period

3 months

First QC Date

September 4, 2019

Last Update Submit

June 26, 2020

Conditions

IUD Insertion Complication

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

Secondary Outcomes (4)

  • the difference in pain scores during tenaculum application

    10 minutes

  • the difference in pain scores during sound insertion

    10 minutes

  • the ease of IUD insertion

    10 minutes

  • women's satisfaction level

    10 minutes

Study Arms (3)

dinoprostone

EXPERIMENTAL

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

Drug: Dinoprostone

misoprostol

ACTIVE COMPARATOR

1 vaginal tablet of misoprostol (200 mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 3 hours before IUD insertion.

Drug: Misoprostol

placebo

PLACEBO COMPARATOR

one tablet of placebo inserted by the study nurse 3 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 3hours before IUD insertion.

dinoprostone
MisoprostolDRUG

1 vaginal tablet of misoprostol (200mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 3 hours before IUD insertion.

misoprostol
placeboDRUG

one tablet of placebo inserted by the study nurse 3 hours before IUD insertion.

placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • nulliparous women requesting copper IUD insertion

You may not qualify if:

  • pregnancy, Parous women, contraindications or allergy to dinoprostone or misoprostol,contraindication to IUD insertion, untreated active cervicitis or vaginitis, undiagnosed abnormal uterine bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Samy

Giza, 11231, Egypt

Location

MeSH Terms

Interventions

DinoprostoneMisoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsProstaglandins E, SyntheticProstaglandins, Synthetic

Study Officials

  • AHMED SAMY

    Cairo University

    PRINCIPAL INVESTIGATOR

  • Mohamed El Sharkawy

    Cairo University

    PRINCIPAL INVESTIGATOR

  • Mohamed El Mahy

    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

September 4, 2019

First Posted

September 6, 2019

Study Start

September 10, 2019

Primary Completion

December 20, 2019

Study Completion

January 20, 2020

Last Updated

June 30, 2020

Record last verified: 2020-06

Locations

EG(1)