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Status unknownNCT03939663Updated May 7, 2019

Role of Vaginal Misoprostol Prior to IUCD Insertion in Women Who Delivered Only by Elective Caesarean Section.

A Phase 2 interventional study of misoprostol and Placebo in IUD Insertion Complication, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-07.

Sponsored by Ain Shams University · Phase 2, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jul 2018, registered May 2019).
Phase
Phase 2
Study type
Interventional
Enrollment
210
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study summary

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

Read the detailed description

Misoprostol ( 400mcg ) vaginally administrated 3 hours prior to IUCD insertion increases the ease and success of insertion and decrease associated pain among women who had delivered only by elective caesarean section.

02

Conditions studied

  • IUD Insertion Complication
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
210 participants (estimated)

Study arms

  • Placebo comparator
    placebo group

    2 tablets vaginally

    Drug: Placebo

  • Experimental
    misoprostol group

    400 mcg vaginally

    Drug: misoprostol

Interventions

  • Drugmisoprostol

    misoprostol 2 tablets

    Also known as: misotac, cytotec

  • DrugPlacebo

    starch pills manufactured to mimic misoprostol 200 mg tablets

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: during insertion

  2. 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.

    Time frame: during insertion

Secondary outcomes

  1. heavy bleeding

    heavy bleeding and blood clots

    Time frame: 7 days

  2. partial or total expulsion

    not insitu by U/S

    Time frame: 4 to 6 weeks

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03939663
Lead sponsor
Ain Shams University
Responsible party
Enas Mahmoud Mohammed Mohammed Elshahed (MBBCh., Ain Shams University) — Principal investigator
First posted
May 7, 2019
Start date
Jul 1, 2018
Primary completion
Jul 1, 2019 (estimated)
Completion
Dec 1, 2019 (estimated)
Last update
May 7, 2019

Study contacts

enas mahmoud, MBBCh
Contact
enasmahmoud957@yahoo.com
01096448037 ext. 01122742293

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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