Comparison of Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Women Delivered Only by Cesarean Delivery

Cairo University (CU)

Status and phase: Unknown; Phase 4

Conditions: IUD Pain

Treatments: Drug: Misoprostol 200Mcg Tab; Drug: Dinoprostone 3 mg; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04080349

dinoprostone misoprostol IUDs

Details and patient eligibility

About

To compare the effect of vaginal dinoprostone versus vaginal misoprostol administered before the copper intrauterine device(IUD) insertion in reducing IUD insertion pain and the difficulty in inserting the IUD in women delivered only by cesarean section.

Full description

Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• women delivered only by elective cesarean section and not received analgesics in the last 24 hours

Exclusion criteria

• contraindications to dinoprostone or misoprostol or IUD insertion and allergy to study drugs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 3 patient groups, including a placebo group

dinoprostone

Experimental group

Description:

1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the study nurse 3 hours before IUD insertion.

Treatment:

Drug: Dinoprostone 3 mg

misoprostol

Active Comparator group

Description:

1 vaginal tablet of misoprostol (200 mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 3 hours before IUD insertion.

Treatment:

Drug: Misoprostol 200Mcg Tab

placebo

Placebo Comparator group

Description:

one tablet of placebo inserted by the study nurse 3 hours before IUD insertion.

Treatment:

Drug: placebo