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

NCT ID: NCT03939663

Last Updated: 2019-05-07

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2019-12-01

Brief Summary

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

Detailed Description

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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.

Conditions

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IUD Insertion Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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placebo group

2 tablets vaginally

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

starch pills manufactured to mimic misoprostol 200 mg tablets

misoprostol group

400 mcg vaginally

Group Type EXPERIMENTAL

misoprostol

Intervention Type DRUG

misoprostol 2 tablets

Interventions

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misoprostol

misoprostol 2 tablets

Intervention Type DRUG

Placebo

starch pills manufactured to mimic misoprostol 200 mg tablets

Intervention Type DRUG

Other Intervention Names

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misotac cytotec

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Enas Mahmoud Mohammed Mohammed Elshahed

MBBCh.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Enas Mahmoud

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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enas mahmoud, MBBCh

Role: CONTACT

01096448037 ext. 01122742293

Facility Contacts

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enas mahmoud, MBBCh.

Role: primary

01096448037 ext. 01096448037

Other Identifiers

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EMMMElshahed

Identifier Type: -

Identifier Source: org_study_id

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