NCT03587077

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
113

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 16, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

July 16, 2018

Status Verified

June 1, 2018

Enrollment Period

7 months

First QC Date

April 9, 2018

Last Update Submit

July 13, 2018

Conditions

IUD Insertion Complication

Outcome Measures

Primary Outcomes (1)

  • rate of successful IUD insertion

    Defined by a distance from the IUD to the endometrial end of less than 25 mm

    10 minutes

Study Arms (2)

study group

EXPERIMENTAL

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: MisoprostolDrug: isosorbide mononitrate

control group

PLACEBO COMPARATOR

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: MisoprostolDrug: Placebos

Interventions

MisoprostolDRUG

vaginal application

control groupstudy group
PlacebosDRUG

vaginal application

control group
isosorbide mononitrateDRUG

vaginal application

study group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAll eligible participants included in the study signed a written informed consent before participation after explaining the nature of the study.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (22)

  • Akintomide H, Sewell RD, Stephenson JM. The use of local anaesthesia for intrauterine device insertion by health professionals in the UK. J Fam Plann Reprod Health Care. 2013 Oct;39(4):276-80. doi: 10.1136/jfprhc-2012-100486. Epub 2013 Feb 5.

    PMID: 23385310BACKGROUND

  • Allen RH, Bartz D, Grimes DA, Hubacher D, O'Brien P. Interventions for pain with intrauterine device insertion. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD007373. doi: 10.1002/14651858.CD007373.pub2.

    PMID: 19588429BACKGROUND

  • Allen RH, Carey MS, Raker C, Goyal V, Matteson K. A prospective cohort study of pain with intrauterine device insertion among women with and without vaginal deliveries. J Obstet Gynaecol. 2014 Apr;34(3):263-7. doi: 10.3109/01443615.2013.868424. Epub 2014 Jan 31.

    PMID: 24483244BACKGROUND

  • Allen RH, Raker C, Goyal V. Higher dose cervical 2% lidocaine gel for IUD insertion: a randomized controlled trial. Contraception. 2013 Dec;88(6):730-6. doi: 10.1016/j.contraception.2013.07.009. Epub 2013 Aug 1.

    PMID: 24012096BACKGROUND

  • Asker C, Stokes-Lampard H, Beavan J, Wilson S. What is it about intrauterine devices that women find unacceptable? Factors that make women non-users: a qualitative study. J Fam Plann Reprod Health Care. 2006 Apr;32(2):89-94. doi: 10.1783/147118906776276170.

    PMID: 16824298BACKGROUND

  • Bahamondes L, Mansour D, Fiala C, Kaunitz AM, Gemzell-Danielsson K. Practical advice for avoidance of pain associated with insertion of intrauterine contraceptives. J Fam Plann Reprod Health Care. 2014 Jan;40(1):54-60. doi: 10.1136/jfprhc-2013-100636. Epub 2013 Sep 27.

    PMID: 24076534BACKGROUND

  • Barber EL, Lundsberg LS, Belanger K, Pettker CM, Funai EF, Illuzzi JL. Indications contributing to the increasing cesarean delivery rate. Obstet Gynecol. 2011 Jul;118(1):29-38. doi: 10.1097/AOG.0b013e31821e5f65.

    PMID: 21646928BACKGROUND

  • Carusi, D. A., & Goldberg, A. B. (2015). Intrauterine contraceptive device: insertion and removal. In: M. Zieman (Ed), UpToDate. Retrieved from http://www.uptodate.com/home .

    BACKGROUND

  • Centers for Disease Control and Prevention. (2013). U.S. selected practice recommendations for contraceptive use, 2013: Adapted from the World Health Organization selected practice recommendations for contraceptive use. Retrieved from http://www.cdc.gov/mmwr/pdf/rr/rr6205.pdf

    BACKGROUND

  • d'Arcangues C. Worldwide use of intrauterine devices for contraception. Contraception. 2007 Jun;75(6 Suppl):S2-7. doi: 10.1016/j.contraception.2006.12.024. Epub 2007 Apr 19.

    PMID: 17531612BACKGROUND

  • Edmunds, M. W., & Mayhew, M. S. (2014). Pharmacology for the primary care provider (4th ed.). St. Louis, MI: Elsevier Mosby.

    BACKGROUND

  • Finer LB, Jerman J, Kavanaugh ML. Changes in use of long-acting contraceptive methods in the United States, 2007-2009. Fertil Steril. 2012 Oct;98(4):893-7. doi: 10.1016/j.fertnstert.2012.06.027. Epub 2012 Jul 13.

    PMID: 22795639BACKGROUND

  • Fox MC, Krajewski CM. Cervical preparation for second-trimester surgical abortion prior to 20 weeks' gestation: SFP Guideline #2013-4. Contraception. 2014 Feb;89(2):75-84. doi: 10.1016/j.contraception.2013.11.001. Epub 2013 Nov 11.

    PMID: 24331860BACKGROUND

  • Heikinheimo O, Inki P, Kunz M, Parmhed S, Anttila AM, Olsson SE, Hurskainen R, Gemzell-Danielsson K. Double-blind, randomized, placebo-controlled study on the effect of misoprostol on ease of consecutive insertion of the levonorgestrel-releasing intrauterine system. Contraception. 2010 Jun;81(6):481-6. doi: 10.1016/j.contraception.2010.01.020. Epub 2010 Mar 1.

    PMID: 20472114BACKGROUND

  • Hubacher D, Reyes V, Lillo S, Zepeda A, Chen PL, Croxatto H. Pain from copper intrauterine device insertion: randomized trial of prophylactic ibuprofen. Am J Obstet Gynecol. 2006 Nov;195(5):1272-7. doi: 10.1016/j.ajog.2006.08.022.

    PMID: 17074548BACKGROUND

  • Kass-Wolff JH, Fisher JE. Evidence-based pain management for endometrial biopsies and IUD insertions. Nurse Pract. 2014 Mar 13;39(3):43-50. doi: 10.1097/01.NPR.0000434094.19101.d1.

    PMID: 24535311BACKGROUND

  • Lopez LM, Bernholc A, Zeng Y, Allen RH, Bartz D, O'Brien PA, Hubacher D. Interventions for pain with intrauterine device insertion. Cochrane Database Syst Rev. 2015 Jul 29;2015(7):CD007373. doi: 10.1002/14651858.CD007373.pub3.

    PMID: 26222246BACKGROUND

  • Maguire K, Morrell K, Westhoff C, Davis A. Accuracy of providers' assessment of pain during intrauterine device insertion. Contraception. 2014 Jan;89(1):22-4. doi: 10.1016/j.contraception.2013.09.008. Epub 2013 Sep 21.

    PMID: 24134898BACKGROUND

  • Singh RH, Thaxton L, Carr S, Leeman L, Schneider E, Espey E. A randomized controlled trial of nitrous oxide for intrauterine device insertion in nulliparous women. Int J Gynaecol Obstet. 2016 Nov;135(2):145-148. doi: 10.1016/j.ijgo.2016.04.014. Epub 2016 Jul 16.

    PMID: 27481016BACKGROUND

  • Winner B, Peipert JF, Zhao Q, Buckel C, Madden T, Allsworth JE, Secura GM. Effectiveness of long-acting reversible contraception. N Engl J Med. 2012 May 24;366(21):1998-2007. doi: 10.1056/NEJMoa1110855.

    PMID: 22621627BACKGROUND

  • Medical Eligibility Criteria for Contraceptive Use: A WHO Family Planning Cornerstone. 4th edition. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK138639/

    PMID: 23741782BACKGROUND

  • Zhuo Z, Yu H, Jiang X. A systematic review and meta-analysis of randomized controlled trials on the effectiveness of cervical ripening with misoprostol administration before hysteroscopy. Int J Gynaecol Obstet. 2016 Mar;132(3):272-7. doi: 10.1016/j.ijgo.2015.07.039. Epub 2015 Dec 11.

    PMID: 26797202BACKGROUND

MeSH Terms

Interventions

Misoprostolisosorbide-5-mononitrate

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Mohamad S. Abdellah, Prof.

    Supervisor

    PRINCIPAL INVESTIGATOR

  • Ihab M. El-Nashar, Prof.

    Supervisor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eman I. Ramadan, BSc

CONTACT

00201063959596emanelmelwany@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 9, 2018

First Posted

July 16, 2018

Study Start

September 1, 2018

Primary Completion

April 1, 2019

Study Completion

May 1, 2019

Last Updated

July 16, 2018

Record last verified: 2018-06