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

IUD Insertion Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03939663
• Other study ID #: EMMMElshahed
• Status: Recruiting
• Phase: Phase 2
• Start date: July 1, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: June 2018
• Source: Ain Shams University
• Contact: enas mahmoud, MBBCh
• Phone: 01096448037
• Email: enasmahmoud957[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: December 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• IUD Insertion Complication

Intervention

Drug:
• misoprostol
misoprostol 2 tablets
• Placebo
starch pills manufactured to mimic misoprostol 200 mg tablets

Locations

Country	Name	City	State
Egypt	Enas Mahmoud	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	heavy bleeding	heavy bleeding and blood clots	7 days
Secondary	partial or total expulsion	not insitu by U/S	4 to 6 weeks