NCT04505943

Brief Summary

To compare the effect of vaginal dinoprostone versus vaginal misoprostol and Isonicotinic Acid Hydrazide 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

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
22 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

11 months

First QC Date

August 6, 2020

Last Update Submit

August 15, 2020

Conditions

IUCD Complication

Outcome Measures

Primary Outcomes (1)

  • The difference in visual analog scale pain scores during intrauterine device insertion

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

    10 minuts

Secondary Outcomes (3)

  • the difference in visual analog scale pain scores during tenaculum application

    10 minuts

  • the ease of IUD insertion

    10 minutes

  • women's satisfaction level: score

    10 minutes

Study Arms (3)

isonicotinic acid hydrazide

EXPERIMENTAL

2vaginal tablet of isonicotinic acid hydrazide inserted by the study nurse12 hours before IUD insertion.

Drug: Isonicotinic Acid Hydrazide

dinoprostone

ACTIVE COMPARATOR

2 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the study nurse 12 hours before IUD insertion.

Drug: dinoprostine

misoprostol

ACTIVE COMPARATOR

2 vaginal tablet of misoprostol (200 mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 12hours before IUD insertion.

Drug: misoprostol

Interventions

Isonicotinic Acid HydrazideDRUG

2 vaginal tablet of isonicotinic acid hydrazide inserted by the study nurse12 hours before IUD insertion.

Also known as: INH
isonicotinic acid hydrazide
dinoprostineDRUG

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

Also known as: prostin
dinoprostone
misoprostolDRUG

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

Also known as: Misotac
misoprostol

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsnulliparous women
Healthy VolunteersNo
Age GroupsAdult (18-64)

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)

Aswan University Hospital

Aswān, 81528, Egypt

Location

MeSH Terms

Interventions

IsoniazidKLK15 protein, humanMisoprostol

Intervention Hierarchy (Ancestors)

HydrazinesOrganic ChemicalsIsonicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingProstaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • nahla w Shady, md

    Aswan universirty

    STUDY CHAIR

Central Study Contacts

hany f Sallam, md

CONTACT

+20102435461hany.farouk@aswu.edu.eg

nahla w Shady, md

CONTACT

+201022336052hanygyne@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
randomized controlled trial
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
A Professor

Study Record Dates

First Submitted

August 6, 2020

First Posted

August 10, 2020

Study Start

September 1, 2020

Primary Completion

July 30, 2021

Study Completion

September 30, 2021

Last Updated

August 18, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)