To evaluate the benefit of Misoprostol prior to hysteroscopy in nulliparous and postmenopausal women regarding the reduction of pain
ID
Source
Brief title
Condition
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain measured by a continuous pain score meter
Secondary outcome
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
Background summary
When a woman is experiencing abnormal uterine bleeding and/or is suspected of
an uterine cavity abnormality the common procedure is a diagnostic or
therapeutic hysteroscopy. Other reasons for hysteroscopy comprehend sub
fertility, recurrent pregnancy loss and sterilization.
Most often hysteroscopy requires extended dilatation of the cervix. There are
different procedures to perform a hysteroscopy. Nowadays the vaginoscopic
hysteroscopy method (also known as the Bettocchi procedure) is increasingly
performed. Especially in postmenopausal women difficulties can be encountered,
since cervical changes decrease elasticity and increase the level of
obliteration. Dilating the cervix can be a painful event and tends to be more
painful in nulliparous women and in postmenopausal stage. Pain is the reason
for failure of hysteroscopy in up to 75% of all cases failed.
Regional or general anaesthesia is time-consuming and not without risks and
thus should only be used when absolutely necessary. Therefore reducing pain is
preferable in order to increase the acceptability of hysteroscopies without
anaesthesia. According to the literature cervical ripening and/or dilatation
could be facilitated by Misoprostol thus reducing pain.
The few studies performed in postmenopausal patients are conflicting regarding
improvement in cervical dilatation and ease of the procedure with previous use
of Misoprostol. More research is needed.
Study objective
To evaluate the benefit of Misoprostol prior to hysteroscopy in nulliparous and
postmenopausal women regarding the reduction of pain
Study design
Randomised double blind placebo controlled multi-centred trial
Intervention
Misoprostol 400 mcg 24 and 12 hours pre-operative, or placebo
Study burden and risks
Nil; only minor adverse events such as nausea and diarhoea have been described
due to Misoprostol. Furthermore the procedure equals a hysteroscopy outside the
trial.
De Boelelaan
1081 HV Amsterdam 1081 HV
NL
De Boelelaan
1081 HV Amsterdam 1081 HV
NL
Listed location countries
Age
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
Allergy for Misoprostol
Previous cervical surgery
Active infection
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-005160-23-NL |
| CCMO | NL38602.029.12 |
| OMON | NL-OMON22053 |