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OpenTrials
Completed

NCT Number: NCT03490617

Misoprostol Prior to IUD Insertion in Nullipara

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.

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Key information

Conditions

Family Planning

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Instituto de Medicina Integral Professor Fernando Figueira

Recife, Pernambuco, 50070450, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Vaginal Misoprostol

Drug

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

Other names: Prostokos

Primary outcomes

  1. Cervical dilatation

    Time frame: four hours after misoprostol use

    the frequency of women with cervical dilation ≤ 4 mm (measured by inserting a #4 Hegar dilator through the internal orifice of the cervix uteri immediately prior to IUD insertion

Secondary outcomes

  1. Difficulty in inserting IUD

    Time frame: four hours after misoprostol use

    subjective difficulty (as reported by the investigator) in inserting the IUD and classified as difficult, very difficult and easy

  2. Pain at insertion

    Time frame: four hours after misoprostol use

    judged subjectively by the woman and evaluated by the investigator using a visual analogue scale (VAS). The scale ranged from 0 to 10, in which zero is the absence of pain and 10 the worst pain imaginable.

Other outcomes

  1. Subjective sensation as reported by the woman

    Time frame: four hours after misoprostol use

    the woman's subjective evaluation of the procedure (IUD insertion)was classified as not disagreeable, slightly disagreeable, disagreeable or very disagreeable.

Sponsors and collaborators

Lead sponsor

Instituto Materno Infantil Prof. Fernando Figueira

Other

Registry information

Official study title

Misoprostol Prior To Cupper Intra Uternine Device Insertion In Nullipara: A Randomized Clinical Trial

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 6, 2018
Registry last updated
Apr 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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