Use of Misoprostol in Case of Insertion Failure of Intrauterine Contraceptives

Luis Bahamondes

Status and phase: Completed; Phase 4

Conditions: Cervical Stenosis

Treatments: Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT01754649

Unicamp/2012/LB

Details and patient eligibility

About

To assess the usefulnes sof misoprostol versus placebo (in a double-blind placebo controlled randomized clinical trial)to facilitate the insertion of copper-IUD and the levonorgestrel-releasing intrauterine system (LNG-IUS) in cases of failure due to cervical stenosis in either nulligravidas and parous women. Additionally to evaluate the side-effects of the misoprostol. The hypothesis is that misoprostol may be better than placebo.

Full description

Women attended at the Family Planning clinic of the University of Campinas who requested the insertion of a copper-IUD or an LNG-IUS and who failed in the attempt due to cervical stenosis will be randomized in two groups (1:1). The study group will receive two doses of misoprostol (200mcg each tablet) vaginal 12 and 4 hours prior insertion and the control group will receive placebo in the same schedule. The sample will be 50 women in each group. After 24 hours of the insertion failure the women will return to the clinic and a new attempt of insertion will be done. At this time we will evaluate if the insertion was able to do or not. The data will be analyzing with χ2 test for independent samples. After that a multiple logistic analysis will be perform to evaluate the associated variables with the result (failure or successful) insertion. The level of significance will be established at P<.005.

Enrollment: 102 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Women aged > 18 and <50 years old; Requesting insertion of and IUD or an LNG-IUS Failure of IUD insertion

Exclusion criteria

Refuse to participate Lost to follow-up at the return visit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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102 participants in 2 patient groups, including a placebo group

misoprostol vaginal 200 mcg

Active Comparator group

Description:

The study group will receive two doses of misoprostol (200mcg each tablet) vaginal 12 and 4 hours prior insertion After 24 hours of the insertion failure the women will return to the clinic and a new attempt of insertion will be done. At this time we will evaluate if the insertion was able to do or not.

Treatment:

Drug: Misoprostol

placebo

Placebo Comparator group

Description:

The placebo group will receive two doses of placebo vaginal 12 and 4 hours prior insertion. After 24 hours of the insertion failure the women will return to the clinic and a new attempt of insertion will be done. At this time we will evaluate if the insertion was able to do or not.

Treatment:

Drug: Misoprostol