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CompletedNCT02412033Updated Jun 1, 2016

Misoprostol Prior to Intrauterine Contraceptive Device Insertion

A Phase 1 interventional study of Misoprostol and Placebo in Pain Prior to IUD Insertion, sponsored by Assiut University. Completed. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2016-06-01.

Sponsored by Assiut University · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
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Study summary

Intrauterine devices (IUDs) are widely used as reversible contraceptives. Both copper- and levonorgestrel (LNG)-releasing IUDs (LNG-IUDs) are safe,cost-effective in the long term and equally effective compared with tubal sterilization.

In addition, the LNG-IUD (Mirena®) provides non contraceptive benefits, such as treatment for menorrhagia, dysmenorrhea and anemia. The current use of IUDs among reproductive-aged women ranges from 8 to 15% worldwide. Reported complications related to IUD insertion are 8.8% insertion failure, 2.8-11.5% cervical problems, 0.2% cervical perforation, 0.2% syncope and 5.8% expulsion. Insertion failures and cervical problems seem to occur more often among women who have never delivered vaginally.

Cervical stenosis, an immature or small cervix and a significantly ante- or retroverted position of the uterus, has been described as factors associated with a difficult sounding of the cervical canal or even failure to insert the IUD.

Misoprostol is an inexpensive prostaglandin E1-analogue, which is associated with few side effect. More over several have shown the benefit of misoprostol as a cervical ripening agent in non pregnant women. Priming with misoprostol prior to hysteroscopy and dilatation and curettage (D\&C) in perimenopausal women resulted in increased cervical dilatation and lower rate of cervical laceration.

The effect of misoprostol on the cellular matrix causes dissolution of collagen fiber increasing the amount of fluid in the stroma and consequentially causes cervical effacement. Fear of pain during insertion, however, might prevent some women from choosing IUD and fears of painful and/or difficult placements may lead them to recommend or counsel women on other, less effective methods.

Women's perception of pain is multifactorial and likely to be influenced by cultural differences and personal experiences; insertion-related pain is therefore difficult to predict. Nevertheless, factors associated with greater pain include nulliparity, not currently breastfeeding and longer time since last pregnancy; of these factors, nulliparity is the strongest predictor of pain.

The proportion of women of reproductive age who are nulliparous is increasing, with women delaying childbirth and having fewer children or choosing to remain childless. The proportion of Caesarean section births has also increased and women who have only ever had a Caesarean section are often viewed as nulliparous with respect to IUD placement. Anticipated pain is often greater than the actual pain experienced, and the majority of nulliparous women experience no more than moderate pain during IUD insertion. However, among nulliparous women there is a subset (about 17%) for whom the insertion of IUD is associated with severe pain.These women need effective pain relief.

For most nulliparous, nulligravid or parous women, IUD insertion can be performed successfully without cervical priming and with a minimum amount of discomfort. Whether selective use of misoprostol has a role in management of pain in certain subsets of women (e.g. nulliparous women and those in whom the insertion is non-routine/difficult) has yet to be adequately studied.

02

Conditions studied

  • Pain Prior to IUD Insertion

Keywords

  • vaginal misoprostol
03

In context

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Include those who delivered by CS .
  2. Who accept to participate in the study.
  3. Desire IUD placement.
  4. Negative pregnancy test.
  5. No history or current history of pelvic inflammatory disease.
  6. No current cervicitis.
  7. No contraindication to IUD insertion (less than 4 week post partum,gynecological malignancy,unexplained vaginal bleeding and pregnancy).

Exclusion criteria

Exclusion Criteria:

  1. Any contraindication to IUD .
  2. Current pregnancy.
  3. Uterine anomaly.
  4. Undiagnosed abnormal uterine bleeding.
  5. Allergy to misoprostol.
  6. Patients contraindicated to administration of misoprostol.
  7. Women who delivered vaginally.
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
140 participants (actual)

Study arms

  • Active comparator
    Misoprostol group

    Going to receive 400 µg misoprostol vaginally 3 hours before IUD insertion.

    Drug: Misoprostol

  • Placebo comparator
    Placebo group

    Going to receive placebo.

    Drug: Placebo

Interventions

  • 400 µg misoprostol vaginally 3 hours before IUD insertion.

  • DrugPlacebo

    This group will receive placebo

06

What researchers measure

Primary outcomes

  1. easiness score of IUD insertion

    Time frame: 5 minutes

Secondary outcomes

  1. the difference in the pain intensity scores between the study groups

    Time frame: 5 minutes

  2. the women's level of satisfaction at the end of insertion

    Time frame: 5 minutes

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02412033
Lead sponsor
Assiut University
Responsible party
mohamad sayed abdellah (Dr, Assiut University) — Principal investigator
First posted
Apr 8, 2015
Start date
Mar 2016
Primary completion
Apr 2016
Completion
May 2016
Last update
Jun 1, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Misoprostol

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