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Vaginal Misoprostol Before Intrauterine Contraceptive Device Insertion

NCT ID: NCT03790371

Last Updated: 2018-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-01

Study Completion Date

2016-08-01

Brief Summary

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

Detailed Description

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Conditions

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Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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misoprostol group

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

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

vaginal misoprostol prior IUD insertion

placebo

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

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

vaginal placebo tablet prior IUD insertion

Interventions

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Misoprostol

vaginal misoprostol prior IUD insertion

Intervention Type DRUG

Placebos

vaginal placebo tablet prior IUD insertion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

One previous failed attempt of IUD insertion.

Exclusion Criteria

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

20 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Radwa Rasheedy Ali

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AinShams university maternity hospital

Cairo, Abbassya, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Ain Shams University MH

Identifier Type: -

Identifier Source: org_study_id