search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


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



- candidate number15264
- NTR NumberNTR4113
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-aug-2013
- Secondary IDsNL38602.029.12 METC
- Public TitleHysmis study.
Misoprostol for cervical priming prior to hysteroscopy in postmenopausal or nulliparous women; a multi-centre randomised placebo controlled trial.
- Scientific TitleHysmis study.
Misoprostol for cervical priming prior to hysteroscopy in postmenopausal or nulliparous women; a multi-centre randomised placebo controlled trial.
- ACRONYMHysmis
- hypothesisMisoprostol prior to hysteroscopy in nulliparous and postmenopausal women will reduce pain during the procedure.
- Healt Condition(s) or Problem(s) studiedHysteroscopy, Pain, Misoprostol
- Inclusion criteriaIndication for diagnostic or therapeutic hysteroscopy
Nulliparity if premenopausal
Postmenopausal state (>1 year after last menstruation)
Adequate command of the Dutch language
Informed consent
- Exclusion criteriaAllergy for Misoprostol
Previous cervical surgery or hysteroscopy
Active infection
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 20-aug-2013
- planned closingdate1-sep-2014
- Target number of participants136
- InterventionsTreatment exists of Misoprostol (a prostaglandine E1-analogue) compared to placebo. Misoprostol ripens the cervix. Therefore the hypothesis is that Misoprostol decreases the pain experienced during hysteroscopy. This is our primary outcome: pain, measured by a continuous pain score meter and a VAS-score.Intervention- and control-groups are similar, randomisation is double blinded. Patients are either postmenopauzal or premenopauzal nullipara. The duration of the intervention is 24 and 12 hours before the hysteroscopie. The patient takes either Misoprostol or placebo, double blinded.
- Primary outcomePain measured by a continuous pain score meter
- Secondary outcomethe 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 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
- Timepoints4 moments for measurement: 1. questionnaire before intake of study medication, 2. questionnaire right before the hysteroscopy, 3. use of the continuous pain score meter during the hysteroscopy, 4. questionaire after the hysteroscopy.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES M.L. Tasma
- CONTACT for SCIENTIFIC QUERIES M.L. Tasma
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- PublicationsN/A
- Brief summaryWhen 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. In our hospital we perform the vaginoscopic also known as the Bettocchi procedure. 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. Local or general anaesthesia is a time-consuming and not a risk less event which is only to be used when absolutely necessary. Therefore another way of reducing pain is preferred. According to 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.
Objective: To evaluate the benefit of Misoprostol prior to hysteroscopy in nulliparous and postmenopausal women regarding the reduction of pain.
- Main changes (audit trail)
- RECORD12-aug-2013 - 29-sep-2013


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl