NCT03490617

Misoprostol Prior to IUD Insertion in Nullipara

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 179 (actual)
• Sponsor: Instituto Materno Infantil Prof. Fernando Figueira · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Vaginal misoprostol	To determine effectiveness of vaginal misoprostol to facilitate IUD insertion in nulligravida women

Timeline

• Start date: 2009-07-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2018-04-06
• Last updated: 2018-04-06

Locations

1 site across 1 country: Brazil