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Misoprostol Prior to Intrauterine Contraceptive Device Insertion

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ClinicalTrials.gov Identifier: NCT02412033
Recruitment Status : Completed
First Posted : April 8, 2015
Last Update Posted : June 1, 2016
Sponsor:
Information provided by (Responsible Party):
mohamad sayed abdellah, Assiut University

Brief 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.


Condition or disease Intervention/treatment Phase
Pain Prior to IUD Insertion Drug: Misoprostol Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Vaginal Misoprostol Prior to Intrauterine Contraceptive Device Insertion in Women With Previous Caesarean Section
Study Start Date : March 2016
Actual Primary Completion Date : April 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

Arm Intervention/treatment
Active Comparator: Misoprostol group
Going to receive 400 µg misoprostol vaginally 3 hours before IUD insertion.
Drug: Misoprostol
400 µg misoprostol vaginally 3 hours before IUD insertion.

Placebo Comparator: Placebo group
Going to receive placebo.
Drug: Placebo
This group will receive placebo




Primary Outcome Measures :
  1. easiness score of IUD insertion [ Time Frame: 5 minutes ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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:

  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.
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Responsible Party: mohamad sayed abdellah, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT02412033    
Other Study ID Numbers: IUD- CS
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by mohamad sayed abdellah, Assiut University:
vaginal misoprostol
Additional relevant MeSH terms:
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Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics