Optimal Timing of Misoprostol Administration Prior to Office Hysteroscopy

Optimal Timing of Misoprostol Administration Prior to Office Hysteroscopy; a Randomized Controlled Trial.

The aim of this study was to determine whether misoprostol administered 12 hours before office hysteroscopy can relieve pain more effectively compared with misoprostol administered 3 hours before office hysteroscopy.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Long interval misoprostol; Drug: Short interval misoprostol

Detailed Description

The interval between misoprostol administration and office hysteroscopy may have an influence on its effectiveness in pain reduction. There are limited data on the optimal interval from administration of misoprostol and office hysteroscopy. In previous studies, time interval from administration of misoprostol and office hysteroscopy ranged between 2 hours and 24 hours.

Till now no studies have yet investigated the optimal timing of misoprostol administration prior to office hysteroscopy or operative hysteroscopy. The aim of this study was to determine whether misoprostol administered 12 hours before office hysteroscopy can relieve pain more effectively compared with misoprostol administered 3 hours before office hysteroscopy

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Obstetrics and Gynecology Department,Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Nulliparous patients who have an indication for office hysteroscopy

Exclusion Criteria:

• Parous patients, menopausal patients and patients with cervical pathology, and previous cervical surgery will be excluded from the study. Moreover, patients with severe vaginal bleeding, acute pelvic inflammatory disease, glaucoma, allergy to misoprostol, cardiac, liver or kidney diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Long interval misoprostol; A small envelope including two labeled plastic bags (A & B) (each bag containing either 2 misoprostol tablets(400µg) or 2 identically appearing placebo tablets) will be packaged in sequentially numbered sealed envelopes. In long interval misoprostol group, bag (A) contains misoprostol tablets and bag (B) contains placebo tablets. After signing the informed consent, the sequentially numbered sealed envelopes will be opened (according to the sequence of attendance of the patient) by the study nurse. Tablets in bag (A) will be inserted 12 hours before office hysteroscopy and tablets in bag (B) will be inserted 3 hours before office hysteroscopy.	Drug: Long interval misoprostol; A rigid 2.9 mm hysteroscope with 30° forward oblique lens and outer sheath diameter of 5 mm will be used in the procedure. The uterine cavity will be distended by warm saline at a pressure between 60-80 mmHg. All the procedures will be performed during the proliferative phase using the vaginoscopic approach as described by Betocchi and Selvaggi in 1997. All the procedures will be diagnostic.Pain intensity will be assessed by visual analogue scale during the examination and 30 minutes after the procedure. A visual analogue scale ranging from 0 to 10 will be used (zero indicates no pain and 10 indicates the worst possible experienced pain).; Other Names: long interval misoprostol group
Active Comparator: Short interval misoprostol; A small envelope including two labeled plastic bags (A& B) (each bag containing either 2 misoprostol tablets(400µg) or 2 identically appearing placebo tablets) will be packaged in sequentially numbered sealed envelopes. In short interval misoprostol group, bag (A) contains placebo tablets and bag (B) contains misoprostol tablets. After signing the informed consent, the sequentially numbered sealed envelopes will be opened (according to the sequence of attendance of the patient) by the study nurse. Tablets in bag (A) will be inserted 12 hours before office hysteroscopy and tablets in bag (B) will be inserted 3 hours before office hysteroscopy.	Drug: Short interval misoprostol; A rigid 2.9 mm hysteroscope with 30° forward oblique lens and outer sheath diameter of 5 mm will be used in the procedure. The uterine cavity will be distended by warm saline at a pressure between 60-80 mmHg. All the procedures will be performed during the proliferative phase using the vaginoscopic approach as described by Betocchi and Selvaggi in 1997. All the procedures will be diagnostic.Pain intensity will be assessed by visual analogue scale during the examination and 30 minutes after the procedure. A visual analogue scale ranging from 0 to 10 will be used (zero indicates no pain and 10 indicates the worst possible experienced pain).; Other Names: short interval misoprostol group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intensity of pain	up to 30 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of procedure	intraoperative

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Usama M Fouda, M.D,PhD, Cairo University

Publications and helpful links

General Publications

• Cicinelli E, Rossi AC, Marinaccio M, Matteo M, Saliani N, Tinelli R. Predictive factors for pain experienced at office fluid minihysteroscopy. J Minim Invasive Gynecol. 2007 Jul-Aug;14(4):485-8. doi: 10.1016/j.jmig.2007.03.008.
• Fouda UM, Gad Allah SH, Elshaer HS. Optimal timing of misoprostol administration in nulliparous women undergoing office hysteroscopy: a randomized double-blind placebo-controlled study. Fertil Steril. 2016 Jul;106(1):196-201. doi: 10.1016/j.fertnstert.2016.03.022. Epub 2016 Mar 31.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: December 10, 2014
• First Submitted That Met QC Criteria: December 11, 2014
• First Posted (Estimate): December 12, 2014

Study Record Updates

• Last Update Posted (Estimate): July 27, 2016
• Last Update Submitted That Met QC Criteria: July 26, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Misoprostol, pain, office hysteroscopy
• 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: Long miso/short miso/hyst