Misoprostol Prior to IUD Insertion in Nullipara

NCT ID: NCT03490617

Last Updated: 2018-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 179 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2011-11-30

Brief Summary

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.

Detailed 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.

Conditions

Family Planning

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Vaginal Misoprostol Group

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

Group Type: ACTIVE_COMPARATOR

Vaginal misoprostol

Intervention Type: DRUG

To determine effectiveness of vaginal misoprostol to facilitate IUD insertion in nulligravida women

Placebo group

Vaginal placebo tablets 4 hours prior to IUD insertion

Group Type: PLACEBO_COMPARATOR

Vaginal misoprostol

Intervention Type: DRUG

To determine effectiveness of vaginal misoprostol to facilitate IUD insertion in nulligravida women

Interventions

Vaginal misoprostol

To determine effectiveness of vaginal misoprostol to facilitate IUD insertion in nulligravida women

Intervention Type: DRUG

Other Intervention Names

Prostokos

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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)

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto Materno Infantil Prof. Fernando Figueira

OTHER

Sponsor Role: lead

Responsible Party

Melania Amorim

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Instituto de Medicina Integral Professor Fernando Figueira

Recife, Pernambuco, Brazil

Countries

Brazil

Other Identifiers

MISO DIU 01

Identifier Type: -

Identifier Source: org_study_id