Sub Lingual Misoprostol Before IUD Insertion in Women With Only Previous Cesarean Section

Ain Shams University

Status and phase: Completed; Phase 3; Phase 2

Conditions: IUD Insertion

Treatments: Drug: Misoprostol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02141321

9010023

Details and patient eligibility

About

The aim of the work is to evaluate the efficacy of the sub lingual prostaglandin E1 synthetic analogue (misoprostol) before IUD insertion to facilitate the procedure in patients delivered before only by cesarean section.

Full description

The study will be conducted at Ain Shams University Maternity Hospital. 124 women candidate for Cu T 380A IUD insertion will be enrolled in the study. Half of them will receive 400 micro gram of misoprostol (Sigma) sub lingually and the other half will receive the placebo two hours before IUD insertion.

Enrollment: 124 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Normal size uterus.
• Willing to participate.
• Candidate for IUD insertion.
• Delivered only by cesarean section.
• Last delivery is more than 40 days before participating in the study.

Exclusion criteria

• Previous vaginal delivery
• Signs of genital infection.
• Menopause.
• Body mass index (BMI) > 35 kg/m2.
• Contraindication to misoprostol.
• Copper allergy.
• Positive pregnancy test.
• Had a prior attempt for IUD insertion.
• Uterine anomalies.
• Uterine fibroid.

Trial design

124 participants in 2 patient groups, including a placebo group

Misoprostol

Experimental group

Description:

Women will receive two sub lingual tablets each containing 200 micro gram misoprostol (Misotac), receiving a total dose of 400 micro grams. Two hour later, Cu T 380A IUD (PREGNA) will be inserted.

Treatment:

Drug: Misoprostol

Placebo

Placebo Comparator group

Description:

Women will receive two sub lingual placebo tablets which will be similar in size, color, odor and shape to the misoprostol tablets. Two hour later, Cu T 380A IUD (PREGNA) will be inserted.

Treatment:

Drug: Placebo