NCT03790371

Brief Summary

the current study was conducted to assess efficacy of vaginal misoprostol before IUD insertion following previous insertion failure

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_3

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

December 27, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 31, 2018

Completed
Last Updated

December 31, 2018

Status Verified

December 1, 2018

Enrollment Period

10 months

First QC Date

December 27, 2018

Last Update Submit

December 27, 2018

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

  • the success rate for IUD insertion.

    the success of IUD insertion after previous attempt failure

    four hours after misoprostol dose

Study Arms (2)

misoprostol group

ACTIVE COMPARATOR

misoprostol (misotac® sigma pharmaceutical industries) 200 mcg vaginally applied ten and four hours prior to the second attempt of IUD insertion

Drug: Misoprostol

placebo

PLACEBO COMPARATOR

while the control group received a placebo tablet in the same regimen as the study group.

Drug: Placebos

Interventions

MisoprostolDRUG

vaginal misoprostol prior IUD insertion

misoprostol group
PlacebosDRUG

vaginal placebo tablet prior IUD insertion

placebo

Eligibility Criteria

Age20 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • One previous failed attempt of IUD insertion.

You may not qualify if:

  • Uterine fibroid distorting the cavity.
  • Anatomical uterine abnormality with distortion of the cavity
  • Current pelvic inflammatory disease or recently treated pelvic inflammatory disease (PID) in the last three months.
  • Current purulent cervicitis (chlamydia or gonorrhea).
  • Immediately after septic abortion.
  • Uterus size less than 6 cm and more than 9 cm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AinShams university maternity hospital

Cairo, Abbassya, 11566, Egypt

Location

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 27, 2018

First Posted

December 31, 2018

Study Start

October 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

December 31, 2018

Record last verified: 2018-12

Locations

EG(1)