NCT03939663

Brief Summary

Role of vaginal misoprostol prior to IUCD insertion in women who delivered only by elective caesarean section.

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
210

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2018

Shorter than P25 for phase_2

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

Study Start

First participant enrolled

July 1, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 7, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

May 7, 2019

Status Verified

June 1, 2018

Enrollment Period

1 year

First QC Date

May 4, 2019

Last Update Submit

May 4, 2019

Conditions

IUD Insertion Complication

Outcome Measures

Primary Outcomes (2)

  • the proportion of failed IUCD insertions regardless of the reason .

    pain reported by particiepant during insertion graded from 1 to 10 on visual analogue scale

    during insertion

  • the degree of difficulty of the IUCD insertion .

    Judged as the resistance of the internal cervical os experienced by the investigator and measured by a 5-point scale.

    during insertion

Secondary Outcomes (2)

  • heavy bleeding

    7 days

  • partial or total expulsion

    4 to 6 weeks

Study Arms (2)

placebo group

PLACEBO COMPARATOR

2 tablets vaginally

Drug: Placebo

misoprostol group

EXPERIMENTAL

400 mcg vaginally

Drug: misoprostol

Interventions

misoprostolDRUG

misoprostol 2 tablets

Also known as: misotac, cytotec
misoprostol group
PlaceboDRUG

starch pills manufactured to mimic misoprostol 200 mg tablets

placebo group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All women will be 20 to 40 years of age.
  • Desires IUCD placement and able to participate.
  • Negative pregnancy test.
  • Willing to follow- up in 6-8 weeks for a standard IUCD follow-up visit.
  • Delivered only by cesarean section.

You may not qualify if:

  • Active cervical infection.
  • Current pregnancy.
  • Uterine anomaly.
  • Fibroid uterus.
  • Copper allergy/Wilson's disease.
  • Undiagnosed abnormal uterine bleeding.
  • Cervical or uterine cancer.
  • Allergy to misoprostol.
  • Previous vaginal delivery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Enas Mahmoud

Cairo, 9999, Egypt

RECRUITING

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

enas mahmoud, MBBCh

CONTACT

01096448037enasmahmoud957@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MBBCh.

Study Record Dates

First Submitted

May 4, 2019

First Posted

May 7, 2019

Study Start

July 1, 2018

Primary Completion

July 1, 2019

Study Completion

December 1, 2019

Last Updated

May 7, 2019

Record last verified: 2018-06

Locations

EG(1)