Optimal Timing of Misoprostol Administration Prior to Office Hysteroscopy

NCT02316301 | Completed Phase 2 DMC

• 1 other identifier: Long miso/short miso/hyst
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Keywords

Misoprostol, pain, office hysteroscopy

Outcome Measures

Primary Outcomes (1)

• Intensity of pain

  up to 30 minutes

Secondary Outcomes (1)

• Duration of procedure

  intraoperative

Study Arms (2)

Long interval misoprostol

EXPERIMENTAL

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

Short interval misoprostol

ACTIVE COMPARATOR

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

Interventions

Long interval misoprostol DRUG

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).

Also known as: long interval misoprostol group

Long interval misoprostol

Short interval misoprostol DRUG

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).

Also known as: short interval misoprostol group

Short interval misoprostol

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Nulliparous patients who have an indication for office hysteroscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Obstetrics and Gynecology Department,Cairo university

Cairo, Cairo Governorate, Egypt

Location

Related Publications (2)

• 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.

  PMID: 17630168 BACKGROUND

• 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.

  PMID: 27037462 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Usama M Fouda, M.D,PhD

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: December 12, 2014
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 27, 2016

Record last verified: 2016-07

Locations

EG (1)