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Search / Trial NCT03490617

Misoprostol Prior to IUD Insertion in Nullipara

Launched by INSTITUTO MATERNO INFANTIL PROF. FERNANDO FIGUEIRA · Mar 30, 2018

Trial Information

Current as of June 23, 2025

Completed

Keywords

Intrauterine Device Misoprostol Nulliparous Women Contraception

ClinConnect Summary

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.

Gender

FEMALE

Eligibility 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)

About Instituto Materno Infantil Prof. Fernando Figueira

Instituto Materno Infantil Prof. Fernando Figueira (IMIP) is a renowned clinical research institution based in Brazil, dedicated to advancing maternal and child health through innovative research and high-quality care. With a commitment to improving health outcomes, IMIP conducts a variety of clinical trials focusing on pediatric and obstetric populations. The institute is equipped with state-of-the-art facilities and a multidisciplinary team of experts, fostering a collaborative environment that emphasizes ethical practices and patient safety. IMIP's research initiatives aim to contribute valuable insights to the medical community, ultimately enhancing the quality of care provided to mothers and children.

Locations

Recife, Pernambuco, Brazil

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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