Misoprostol Prior to IUD Insertion in Nullipara

Instituto Materno Infantil Prof. Fernando Figueira

Status and phase: Completed; Phase 3

Conditions: Family Planning

Treatments: Drug: Vaginal misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT03490617

MISO DIU 01

Details and patient eligibility

About

The use of misoprostol at a dose of 400 µg administered vaginally four hours prior to IUD insertion increased the ease of insertion and reduced the incidence of pain during the procedure, although the frequency of cramps increased following misoprostol use.

Full description

Nulligravidas women of reproductive age were submitted to IUD insertion between July 2009 and November 2011 at the Instituto de Medicina Integral Prof. Fernando Figueira in Recife, Pernambuco, Brazil. A total of 179 women were randomly allocated to two groups: 86 to use 400 µg of misoprostol vaginally four hours prior to IUD insertion and 93 to use placebo. Risk ratios (RR) were calculated as measures of relative risk, together with their 95% confidence intervals (95%CI). The number needed to treat (NNT) and the number needed to harm (NNH) were also calculated.

Enrollment: 179 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Nulliparous women
• No chirurgical procedure in the cervix
• Wish to use IUD as a contraceptive method

Exclusion criteria are as follows:

• Presence of active cervical infection visible upon speculum exam (purulent cervicits)
• Pelvic Inflammatory Disease (PID) or other uterine infection diagnosed within the last 3 months (based on self-report or clinical documentation)
• Pregnancy ending less than 6 weeks prior to enrollment in study
• History of prior IUD placement
• History of uterine cavity abnormality including Mullerian tract anomalies and leiomyomas distorting uterine cavity shape
• History of uterine surgery
• Allergy or intolerance to misoprostol or other prostaglandin
• Undiagnosed abnormal vaginal bleeding
• Malignancy of the genital tract
• Allergy to any component of the IUD or Wilson's disease (for copper- containing IUDs)
• Pre-procedure use of anesthesia or analgesia (including use of narcotics, benzodiazepines, or use of anesthetic beyond use at the tenaculum site)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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179 participants in 2 patient groups, including a placebo group

Vaginal Misoprostol Group

Active Comparator group

Description:

Vaginal misoprostol (400 μg) 4 hours prior to IUD insertion

Treatment:

Drug: Vaginal misoprostol

Placebo group

Placebo Comparator group

Description:

Vaginal placebo tablets 4 hours prior to IUD insertion

Treatment:

Drug: Vaginal misoprostol