Same-day Cervical Preparation With Misoprostol Before Hysteroscopy

Same-day Cervical Preparation With Misoprostol Before Hysteroscopy: a Randomized Trial of Different Routes of Administration

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02474433

Enrollment

120

Registered

2015-06-17

Start date

2015-07-31

Completion date

2017-07-31

Last updated

2016-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Preparation Prior to Hysteroscopy

Brief summary

This is a randomized trial, assessing Misoprostol efficacy in cervical preparation several hours prior to hysteroscopy, comparing the different routes of administration (PO/PV/buccal). Initial cervical dilatation will be assessed, as well as surgical ease of dilatation, time required to achieve dilatation and patient preference.

Interventions

DRUGMisoprostol (Cytotec)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Caregiver)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Patients admitted for elective hysteroscopy (diagnostic/surgical) at Wolfson Medical Center * Written consent supplied

Exclusion criteria

* Contraindications to prostaglandin treatment (severe asthma, glaucoma, severe cardiac disease, renal failure) * Prostaglandin allergy * Pregnancy * Genital infection * Space-occupying lesion in the endocervical canal * Prior cervical surgery

Design outcomes

Primary

Measure	Time frame	Description
Preoperative cervical width in centimeters	intraoperative	Initial cervical dilatation assessed by performing cervical dilatation , beginning with a number 10 Hegar dilator and subsequently inserting smaller Hegar dilators until the dilator can pass through the internal os without resistance. The largest one to pass will consist the initial cervical width.

Secondary

Measure	Time frame	Description
Time required to achieve cervical dilatation	intraoperative	The time in minutes required for dilatation up to a number 10 Hegar
Ease of cervical dilatation	intraoperative	The subjective ease of cervical dilatation recorded by the surgeon on a 5-point Likert scale (1-very difficult, 5- very easy)
Patient preference	baseline	Patient acceptability of the administration of medication on a 5-point Likert scale (1-very uncomfortable, 5-very comfortable)
Adverse effects of medication	baseline	Self reported misoprostol-associated adverse effects before the procedure (such as nausea, vomiting)
Surgical complications	intraoperative	Complications arising during surgery (perforation, cervical laceration, excess bleeding)

Countries

Israel

Contacts

Primary ContactHadas Ganer Herman, MD

hadassganer@yahoo.com972526206696

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026