Hysmis Study Misoprostol for cervical priming prior to hysteroscopy in postmenopausal or nulliparous women; a multi-centre randomised placebo controlled trial

Hysmis Study Misoprostol for cervical priming prior to hysteroscopy in postmenopausal or nulliparous women; a multi-centre randomised placebo controlled trial - Hysmis Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39813

Enrollment

136

Registered

2013-04-11

Start date

2013-10-15

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

hysteroscopy pain

Interventions

Misoprostol 400 mcg 24 and 12 hours pre-operative, or placebo

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Indication for diagnostic or therapeutic hysteroscopy Nulliparity if premenopausal Postmenopausal state (>1 year after last menstruation) Adequate command of the Dutch language Informed consent

Exclusion criteria

Exclusion criteria: Allergy for Misoprostol Previous cervical surgery Active infection

Design outcomes

Primary

Measure	Time frame
Pain measured by a continuous pain score meter	—

Secondary

Measure	Time frame
the postoperative pain measured directly after the procedure measured as VAS-score by questionnaire (questionnaire nr 3) the pain during passage of the cervix measured as the Peak Pain Score (PPS) and the Average Pain per Second (APS) the total experienced pain during the procedure measured as AUC and PPS the level of difficulty of the hysteroscopy experienced by the surgeon, measured by a Likert 5-point Scale the total operating time the number of succesful procedures the duration of cervical passage the intra-operator differences the differences in pain score between vaginal nullipara and multipara the acceptability of the procedure again the preference to undergo the procedure under general anesthesia adverse events including nausea, vomiting, diarrhoea, fever, abdominal pain and vaginal bleeding complications such as perforation, bleeding, nausea, vomiting, syncope and heavy pain	—

Measure

Time frame

the postoperative pain measured directly after the procedure measured as VAS-score by questionnaire (questionnaire nr 3) the pain during passage of the cervix measured as the Peak Pain Score (PPS) and the Average Pain per Second (APS) the total experienced pain during the procedure measured as AUC and PPS the level of difficulty of the hysteroscopy experienced by the surgeon, measured by a Likert 5-point Scale the total operating time the number of succesful procedures the duration of cervical passage the intra-operator differences the differences in pain score between vaginal nullipara and multipara the acceptability of the procedure again the preference to undergo the procedure under general anesthesia adverse events including nausea, vomiting, diarrhoea, fever, abdominal pain and vaginal bleeding complications such as perforation, bleeding, nausea, vomiting, syncope and heavy pain

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)