Comparative Efficacy of Lidocaine Spray Versus Vaginal Dinoprostone in IUD Insertion

Cairo University (CU)

Status and phase: Unknown; Phase 4

Conditions: Contraception

Treatments: Drug: lidocaine spray; Drug: placebo; Drug: vaginal dinoprostone

Study type: Interventional

Funder types: Other

Identifiers

NCT04339361

lidocaine spray IUD

Details and patient eligibility

About

the aim of this study is to compare the safety and Efficacy of Lidocaine Spray Versus Vaginal dinoprostone in relieving pain during levonorgestrel IUD Insertion in nulliparous women

Enrollment: 111 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• nulliparous women requesting levonorgestrel IUD insertion

Exclusion criteria

• multiparous women, allergy or contraindication to study drugs or contraindications to LNG-IUD insertion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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111 participants in 3 patient groups, including a placebo group

lidocaine spray

Experimental group

Description:

four puffs (50ml, 10 mg/puff) of lidocaine spray will be applied to the cervical canal and cervix before tenaculum placement plus vaginal placebo will be given 3 hours before IUD insertion

Treatment:

Drug: lidocaine spray

vaginal dinoprostone

Active Comparator group

Description:

vaginal dinoprostone 3 mg will be given 3 hours before IUD insertion plus four puffs of saline spray will be applied to the cervical canal and cervix before tenaculum placement

Treatment:

Drug: vaginal dinoprostone

placebo

Placebo Comparator group

Description:

vaginal placebo will be given 3 hours before IUD insertion plus four puffs of saline spray will be applied to the cervical canal and cervix before tenaculum placement

Treatment:

Drug: placebo