NCT04301349

Brief Summary

the aim of this study is to compare the safety and efficacy of vaginal dinoprostone vs vaginal misoprostol administration prior to IUD insertion in multiparous women regarding reduction in iud insertion pain

Trial Health

35
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 P25-P50 for phase_3

Timeline
Completed

Started Mar 2020

Shorter than P25 for phase_3

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

March 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

March 15, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

3 months

First QC Date

March 6, 2020

Last Update Submit

March 9, 2020

Conditions

IUD Insertion Pain

Outcome Measures

Primary Outcomes (1)

  • pain during IUD insertion: visual analog scale

    pain during IUD insertion assessed by the visual analog scale from 0=no pain to 10 = the worst pain imaginable

    2 minutes

Secondary Outcomes (1)

  • duration of IUD insertion

    5 minutes

Study Arms (3)

vaginal dinoprostone

EXPERIMENTAL

vaginal dinoprostone 6 mg (two tablets) 3 hours prior to IUD insertion

Drug: vaginal dinoprostone

vaginal misoprostol

ACTIVE COMPARATOR

vaginal misoprostol 400 mcg (two tablets) 3 hours prior to IUD insertion

Drug: vaginal misoprostol

placebo

PLACEBO COMPARATOR

two tablets of placebo similar in shape ,color, odor to the study drugs

Drug: placebo

Interventions

vaginal dinoprostoneDRUG

two tablets of vaginal dinoprostone (6 mg) 3 hours prior to IUD insertion

vaginal dinoprostone
vaginal misoprostolDRUG

two tablets of vaginal misoprostol (400 mcg) 3 hours prior to IUD insertion

vaginal misoprostol
placeboDRUG

two tablets of placebo given 3 hours prior to IUD insertion

placebo

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • multiparous women requesting IUD insetion

You may not qualify if:

  • active genital infection,uterine anomalies, and contraindication or allergy to dinoprostone or misoprostol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • AHMED SAMY

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

AHMED SAMY, MD

CONTACT

+201100681167ahmedsamy8233@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
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 obstetrics and gynecology

Study Record Dates

First Submitted

March 6, 2020

First Posted

March 10, 2020

Study Start

March 15, 2020

Primary Completion

June 15, 2020

Study Completion

June 30, 2020

Last Updated

March 10, 2020

Record last verified: 2020-03