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

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

Study Overview

• Status: Unknown
• Conditions: IUD Insertion Complication
• Intervention / Treatment: Drug: Placebo; Drug: misoprostol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 9999
    • Recruiting
    • Enas Mahmoud
    • Contact: enas mahmoud, MBBCh.; Phone Number: 01096448037 01096448037; Email: enasmahmoud957@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo group; 2 tablets vaginally	Drug: Placebo; starch pills manufactured to mimic misoprostol 200 mg tablets
Experimental: misoprostol group; 400 mcg vaginally	Drug: misoprostol; misoprostol 2 tablets; Other Names: cytotec; misotac

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
heavy bleeding	heavy bleeding and blood clots	7 days
partial or total expulsion	not insitu by U/S	4 to 6 weeks

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: May 4, 2019
• First Submitted That Met QC Criteria: May 4, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Actual): May 7, 2019
• Last Update Submitted That Met QC Criteria: May 4, 2019
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: EMMMElshahed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No