Efficacy and Safety of Different Doses of Vaginal Misoprostol Prior to Intra Uterine Contraceptive Device Insertion

investigators aim through this study to evaluate and compare the Safety and efficacy of different doses of misoprostol prior to IUCD insertion among women with nulliparous cervix beside the rate of occurrence of adverse effects.

Study Overview

• Status: Completed
• Conditions: Intra-uterine Device Complication
• Intervention / Treatment: Drug: Misoprostol

Detailed Description

Today there is an ever-increasing variety of effective contraceptive methods. Although all have side effects, they offer a lower risk than that conferred by pregnancy Contraceptive methods are classified according to their effectiveness. The top tier offer the highest level of effectiveness (defined as <two pregnancies per 100 women per year) and fulfill the criteria of ease of use, long duration of action, minimal need for return visits to the clinic and minimal user motivation or intervention. These methods include intrauterine contraception, sub dermal contraceptive implants and male and female sterilization The American Congress of Obstetricians and Gynecologists encourages all women, especially adolescents, to use long-acting reversible contraception.

Although intrauterine devices (IUDs) are safe, reliable and highly effective forms of long- acting reversible contraception and has a very low failure rate (0.2-0.6 per 100 women per year) , it is used by only 7.6% and 14.5% of contraceptive users in developed and developing countries, respectively

According to the latest practice recommendations for contraceptive use by the Centers for Disease Control and Prevention, the potential barriers to IUD use include anticipated insertion pain and health care providers' concerns about difficult insertion ( It is therefore important to identify effective approaches to ease IUD insertion in order to overcome obstacles hindering IUD use

Insertion-associated pain is related to speculum insertion, tenaculum traction on the cervix, sounding of the uterus, passing of the insertion tube through the cervix and placement of the device within the uterine cavity

Failure of insertion occurs in up to 14% and 20% of parous and nulliparous women, respectively 13).

It has been suggested that difficulty and failure of insertion are experienced more in nulliparous women (adjusted odds ratio [AOR] 5.19; 95% confidence interval [CI] 2.49, 10.82) and in those with previous Caesarean delivery (AOR 5.38; 95% CI 2.58, 11.22), due to a narrower cervical os Fouda et al. found that women who had delivered only by Caesarean section experienced more pain with IUD insertion compared with women with previous vaginal delivery

Many investigators have studied how to minimize insertion pain or failure. Few studies, however, have assessed any measure to decrease pain or difficulty during IUD insertion in women with previous Caesarean delivery (and no prior vaginal delivery) Pergialiotis et al. conducted a meta-analysis of clinical trials of analgesic options for IUD placement. Owing to the small number of trials, however, they concluded that further studies were needed before a conclusion could be reached

Misoprostol is a synthetic analog of prostaglandin E1 originally approved for treatment and prevention of gastric ulcers induced by non steroidal anti inflammatory drugs. It can be administered sublingually, orally, vaginally, or rectally. Vaginal administration has been associated with the highest peak serum levels of misoprostol, and overall bioavailability is greatest for sublingual and vaginal administration.

Misoprostol has well-known cervical ripening and uterotonic effects, naturally leading to its use as an adjunct in many gynecologic procedures. Its use has been well studied in the hysteroscopy literature. Multiple well-designed studies have validated the efficacy of different doses of misoprostol before hysteroscopy in reducing pain with dilation, reducing the number of failed dilations, and increasing cervical canal diameter before dilation Given these data, it is reasonable to hypothesize that pretreatment with misoprostol could aid in IUD insertion.

As existing studies examining this question have asserted varied conclusions, through this study investigators will evaluate and compare the safety and efficacy of different doses of misoprostol prior to IUCD insertion among women with nulliparous cervix beside the rate of occurrence of adverse effects.

This study aims to compare the efficacy and safety of different doses of vaginal misoprostol prior to IUCD insertion among women with nulliparous cervix "those who never delivered vaginally".

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain shams university maternity hospital
  • Cairo, Egypt
    • Misr University for Science & Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Non-pregnant,
• Nulliparous cervix: no previous vaginal delivery or any attempt of vaginal delivery,
• Seeking for IUD insertion,
• Signing an informed consent to participate in the study,

Exclusion Criteria:

• Pregnancy or signs of pregnancy,
• Signs of cervicitis,
• Any uterine abnormalities as congenital anomalies, endometrial lesions, adenomyosis, fibroids and intrauterine adhesions,
• Women with any kind of pelvic pain,
• Abnormal uterine bleeding,
• History of cervical surgery,• Vaginal delivery,
• Contraindication to misoprostol as allergy,
• Administration of any analgesics last 12h,
• Withdrawal of consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 1- Group 1 (misoprostol 200 mcg; Group 1 :will take 1 tablet (200 mcg) of misoprostol and 1 placebo tablet, .,	Drug: Misoprostol; Tablets will be inserted digitally by an experienced gynecologist 3hours before IUD insertion with taking care not inserting the medication into the cervix.; Other Names: misotac
ACTIVE_COMPARATOR: 2- Group 2 (misoprostol 100 mcg); Group 2: will take1 tablet (100 mcg) of misoprostol and 1 placebo tablet,	Drug: Misoprostol; Tablets will be inserted digitally by an experienced gynecologist 3hours before IUD insertion with taking care not inserting the medication into the cervix.; Other Names: misotac
PLACEBO_COMPARATOR: 3- Group 3 (placebo group); Group 3 ): will take2 placebo tablets	Drug: Misoprostol; Tablets will be inserted digitally by an experienced gynecologist 3hours before IUD insertion with taking care not inserting the medication into the cervix.; Other Names: misotac

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores	Pain scores will be measured using a visual analogue scale (VAS) consisting of a 10 cm horizontal straight line on which 0 cm corresponded to no pain and 10 cm to the worst pain. The pain score will be measured within 5 min of insertion of the IUD tube.	during insertion of IUCD

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The ease of IUD insertion	The ease of IUD insertion: using the ease of insertion score (ES): a graduated VAS-like scale from 0 to 10; in which 10 means terribly difficult insertion and 0 means very easy insertion. The ES was validated for use in previous similar studies about IUD insertion (Abbas et al., 2017).	during insertion ofIUCD
Successful IUD insertion	Successful IUD insertion which will be assessed by vaginal US device 'Samsung h 60' through the following criteria: IUD is centrally located within the endometrial cavity; The crossbar is positioned in the fundal area.; The distance from the top of the uterine cavity to the IUD should be 3 mm or less. This ultrasound scan will be performed just after the IUCD insertion.	5minutes after insertion of IUCD
The duration of insertion in seconds	The duration of insertion in seconds: starting from putting loaded applicator at the external os till withdrawal of the applicator after IUD insertion	during insertion ofIUCD
The women's level of satisfaction at the end of insertion	The women's level of satisfaction at the end of insertion: every woman will express her level of satisfaction with IUD insertion by completing a 10-cm VAS (with 0 = no satisfaction and 10 = maximum satisfaction).	1 miute after insertion of IUCD

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The side effects of the study medication	as shivering, nausea, vomiting and diarrhea	within 3 hours from inserting the misoprostol tablet
Complications from IUD insertion	as abdominal cramps, uterine bleeding, perforation and cervical trauma	during insertion ofIUCD
The number of women who need additional analgesics after the insertion		5 minutes after insertion
Failure of IUD insertion, due to technical difficulty or intolerance of the patient		during IUCD insertion

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Mohamed h Salama, MD.MRCOG, Ainshams uinversity

Publications and helpful links

General Publications

• Abbas AM, Abdellah MS, Khalaf M, Bahloul M, Abdellah NH, Ali MK, Abdelmagied AM. Effect of cervical lidocaine-prilocaine cream on pain perception during copper T380A intrauterine device insertion among parous women: A randomized double-blind controlled trial. Contraception. 2017 Mar;95(3):251-256. doi: 10.1016/j.contraception.2016.10.011. Epub 2016 Nov 4.
• Abdellah MS, Abbas AM, Hegazy AM, El-Nashar IM. Vaginal misoprostol prior to intrauterine device insertion in women delivered only by elective cesarean section: a randomized double-blind clinical trial. Contraception. 2017 Jun;95(6):538-543. doi: 10.1016/j.contraception.2017.01.003. Epub 2017 Jan 11.
• Aronsson A, Fiala C, Stephansson O, Granath F, Watzer B, Schweer H, Gemzell-Danielsson K. Pharmacokinetic profiles up to 12 h after administration of vaginal, sublingual and slow-release oral misoprostol. Hum Reprod. 2007 Jul;22(7):1912-8. doi: 10.1093/humrep/dem098. Epub 2007 May 8.
• Bahamondes MV, Espejo-Arce X, Bahamondes L. Effect of vaginal administration of misoprostol before intrauterine contraceptive insertion following previous insertion failure: a double blind RCT. Hum Reprod. 2015 Aug;30(8):1861-6. doi: 10.1093/humrep/dev137. Epub 2015 Jun 3.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2020
• Primary Completion (ACTUAL): June 15, 2020
• Study Completion (ACTUAL): June 30, 2020

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 17, 2020
• First Posted (ACTUAL): February 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: misoprostol; IUCD
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: Misoprostol Prior to IUCD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No