Misoprostol Prior to IUD Insertion in Nullipara

Last updated: March 30, 2018
Sponsor: Instituto Materno Infantil Prof. Fernando Figueira
Overall Status: Completed

Phase

3

Condition

Reproductive Health

Birth Control

Contraception

Treatment

N/A

Clinical Study ID

NCT03490617
MISO DIU 01
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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)

Study Design

Total Participants: 179
Study Start date:
July 01, 2009
Estimated Completion Date:
November 30, 2011

Study 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.

Connect with a study center

  • Instituto de Medicina Integral Professor Fernando Figueira

    Recife, Pernambuco 50070450
    Brazil

    Site Not Available

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