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

Ain Shams University

Status and phase: Unknown; Phase 2

Conditions: IUD Insertion Complication

Treatments: Drug: misoprostol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03939663

EMMMElshahed

Details and patient eligibility

About

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

Full 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.

Enrollment: 210 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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210 participants in 2 patient groups, including a placebo group

placebo group

Placebo Comparator group

Description:

2 tablets vaginally

Treatment:

Drug: Placebo

misoprostol group

Experimental group

Description:

400 mcg vaginally

Treatment:

Drug: misoprostol