Vaginal Misoprostol Before Intrauterine Contraceptive Device Insertion

Ain Shams University

Status and phase: Completed; Phase 3

Conditions: Contraception

Treatments: Drug: Misoprostol; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT03790371

Ain Shams University MH

Details and patient eligibility

About

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

Enrollment: 90 patients

Sex: Female

Ages: 20 to 44 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups, including a placebo group

misoprostol group

Active Comparator group

Description:

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

Treatment:

Drug: Misoprostol

placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebos