Pain Relief During IUD Insertion in Women Delivered Only by Elective Cesarean Section

July 13, 2018 updated by: Eman Ibrahim Ramadan Abdelrahman, Assiut University

Effect of Adding Vaginal Isosorbide Mononitrate to Misoprostol Prior to Intrauterine Device Insertion in Women Delivered Only by Elective Cesarean Section: a Randomized Double-blind Controlled Clinical Trial

The aim of the work is to assess the effect of combined misoprostol 200 mcg and isosorbide mononitrate 40 mg versus misoprostol 200 mcg and placebo as local vaginal tablet on the successful IUD insertion.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Fear of pain during insertion of an IUD may deter women from choosing the IUD as a method of contraception. According to Hubacher et al. predictors of increased pain during IUD insertion include nulliparity, age greater than 30 years, lengthier time since last pregnancy or last menses, and not currently breastfeeding. Allen et al. predicted pain to be greater based on history of no previous vaginal delivery, and difficulty of the procedure. Pharmacological interventions for pain control during IUD insertion include analgesics, local anesthetics, and the use of prostaglandins to soften the cervix; however, there is wide variation in the use of these methods . Misoprostol has also been proposed as an agent to ease IUD insertion and decrease procedure-associated pain .

Nitrous oxide has been used for years for procedural analgesia in outpatient settings and has recently been investigated as an approach to pain management in the context of IUD insertion .

Sewell and Vincent have been offering nitrous oxide for reducing the pain of IUD insertion and have had a positive response.

Study Type

Interventional

Enrollment (Anticipated)

113

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:We will include

  • Nonpregnant women,
  • aged 18-45 years, .delivered before only by elective CS and did not receive any analgesics in the 24 h prior to IUD insertion.

Exclusion Criteria:We will exclude

  • Women with any uterine abnormalities as congenital anomalies,
  • Women with endometrial lesions,
  • Women with adenomyosis,
  • Women with fibroids,
  • Women with intrauterine adhesions,
  • Women with chronic pelvic pain,
  • Women with spasmodic dysmenorrhea,
  • Women with abnormal uterine bleeding,
  • Women with history of cervical surgery, .Women with allergy to misoprostol or isosorbide mononitrate or any medical disease that contraindicates its use and those who refused to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: study group
Women will receive vaginally one tablet misoprostol 200 mcg(Misotac; Sigma Pharma, SAE, EGYPT) plus one tablet isosorbide mononitrate 40 mg(Effox 40 mg; Minapharm). A trained clinical nurse will introduce the tablets, digitally without using speculum, 3 hours before IUD insertion into the posterior vaginal fornix of the woman while lying in the lithotomy position.
Drug: Misoprostol
vaginal application
Drug: isosorbide mononitrate
vaginal application
PLACEBO_COMPARATOR: control group
Women will receive vaginally one tablet misoprostol 200 mcg Plus one tablet placebo.A trained clinical nurse will introduce the tablets, digitally without using speculum, 3 hours before IUD insertion into the posterior vaginal fornix of the woman while lying in the lithotomy position.
Drug: Misoprostol
vaginal application
Drug: Placebos
vaginal application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of successful IUD insertion
Time Frame: 10 minutes
Defined by a distance from the IUD to the endometrial end of less than 25 mm
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Mohamad S. Abdellah, Prof., supervisor
  • Principal Investigator: Ihab M. El-Nashar, Prof., supervisor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2018

Primary Completion (ANTICIPATED)

April 1, 2019

Study Completion (ANTICIPATED)

May 1, 2019

Study Registration Dates

First Submitted

April 9, 2018

First Submitted That Met QC Criteria

July 13, 2018

First Posted (ACTUAL)

July 16, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 16, 2018

Last Update Submitted That Met QC Criteria

July 13, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pain during IUD insertion

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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