---
title: Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women
nct_id: NCT01147497
overall_status: COMPLETED
phase: NA
sponsor: Emory University
study_type: INTERVENTIONAL
primary_condition: Contraception
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01147497.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01147497"
ct_last_update_post_date: 2018-01-12
last_seen_at: "2026-05-12T06:06:51.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women

**Official Title:** A Randomized Control Trial of Misoprostol Versus Placebo for Cervical Priming in Intrauterine Device Insertion for Nulliparous Women

**NCT ID:** [NCT01147497](https://clinicaltrials.gov/study/NCT01147497)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 78
- **Lead Sponsor:** Emory University
- **Conditions:** Contraception
- **Start Date:** 2010-06
- **Completion Date:** 2011-09
- **CT.gov Last Update:** 2018-01-12

## Brief Summary

Because of misoprostol's known ability to cause cervical dilation, some family planning providers give their patients a dose of this drug prior to insertion. The goal of this study is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain.

## Detailed Description

There are currently 2 intrauterine devices (IUDs) available in the U.S., the copper T380 (paragard) and levonorgestrel IUD (Mirena). The effectiveness of IUDs is very similar to tubal sterilization\[1\], with an overall unintended pregnancy rate of less than 1% in the first year, and lower failure rates in subsequent years. The cervix of a nulliparous woman has a smaller diameter and can lead to more difficult and uncomfortable IUD insertions. Because of misoprostol's known ability to cause cervical dilation, some family planning providers give their patients a dose of this drug prior to insertion. The goal of this study is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain. The null hypothesis is that misoprostol does not influence difficulty of insertion or patient perception of pain. The primary outcome is the ability to insert the IUD without dilation of the cervix or using ultrasound for guidance.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 45 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* 18 years
* negative pregnancy test
* no prior pregnancy beyond 19 6/7 weeks
* no pelvic inflammatory disease in last 3 months
* no current cervicitis
* willing to follow up in 1-2 months

Exclusion Criteria:

* active cervical infection
* current pregnancy
* prior pregnancy beyond 19 6/7 weeks
* uterine anomaly
* fibroid uterus distorting uterine cavity
* copper allergy or wilson's disease for ParaGard
* undiagnosed abnormal uterine bleeding
* cervical or uterine cancer
* sepsis associated with the most recent pregnancy
* current breast cancer for levonogestrel IUD
* inflammatory bowel disease
* allergy to misoprostol
```

## Arms

- **misoprostol** (EXPERIMENTAL) — Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
- **placebo** (PLACEBO_COMPARATOR) — Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit

## Interventions

- **Misoprostol** (DRUG) — 400mcg of misoprostol taken buccally 2 hours prior to IUD insertion visit
- **Placebo** (DRUG) — Pill that is identical to the study drug in appearance, taste and smell, taken buccally 2 hours prior to IUD insertion visit

## Primary Outcomes

- **Provider Perceived Ease of Insertion on a 100 Point Visual Analogue Scale** _(time frame: assessed immediately post IUD insertion)_ — The visual analogue scale for perceived ease ranges from 0 (most ease) to 100 (most difficult).

## Secondary Outcomes

- **Patient Perceived Pain on a 100 Point Visual Analogue Scale** _(time frame: immediately after insertion)_
- **The Use of Adjunctive Measures Including Ultrasound Guidance or Cervical Dilation to Insert the IUD** _(time frame: assessed immediately after IUD insertion)_
- **Time for Insertion Procedure** _(time frame: assessed immediately after IUD insertion)_
- **Acceptability of Discomfort Associated With Insertion** _(time frame: assessed at one week after insertion and at one month after insertion)_
- **Ease of Insertion and Presence of Pain in Nulliparous Women Versus Nulligravid Women** _(time frame: assessed immediately following insertion)_
- **Need for Additional Pain Medications After Insertion of the IUD** _(time frame: assessed one week after insertion)_

## Locations (1)

- The Emory Clinic, Atlanta, Georgia, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.the emory clinic|atlanta|georgia|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01147497.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01147497*  
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