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Reduction of delayed reporting of reduced fetal movements with the introduction of information about fetal movements.


- candidate number21891
- NTR NumberNTR5127
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-mrt-2015
- Secondary IDs15-N-36 
- Public TitleReduction of delayed reporting of reduced fetal movements with the introduction of information about fetal movements.
- Scientific TitlePatient delay at reduced fetal movements
- ACRONYM
- hypothesisThe objective of this study is to determine whether the patient information leaflet leads to less patient delay at reduced fetal movements. The intention and the actual behavior of pregnant women will be examined.
- Healt Condition(s) or Problem(s) studiedReduced fetal movements, Patient delay
- Inclusion criteria- singleton pregnancy - nulliparous - +/- 20 weeks gestation - No fetal abnormalities on routine ultrasonography (SEO) - Knowledge of the Dutch language
- Exclusion criteria- multiparous - multiple pregnancy - fetal abnormalities on routine ultrasonography (SEO) - no knowledge of dutch language
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytype[default]
- planned startdate 7-apr-2015
- planned closingdate1-mrt-2016
- Target number of participants200
- InterventionsStepped wedge design. AD 20wk the patients will be asked to perform in this trial. Around 24 weeks they will fill in the first questionnaire. After completing the questionnaire 100 patients will receive information leaflet about the child moves on their regular pregnancy check around 24 wks. Four weeks later, all pregnant women receive the 2nd questionnaire. The 100 pregnant women who didn't received the leaflet will receive this after completing the second questionnaire.
- Primary outcomepatient delay
- Secondary outcomeknowledge of fetal movements possible tresholds
- TimepointsAD 24weeks AD 28 weeks
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Karin K.J.W.M. Wackers
- CONTACT for SCIENTIFIC QUERIES Karin K.J.W.M. Wackers
- Sponsor/Initiator Atrium-Orbis Medisch Centrum
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summary
- Main changes (audit trail)24-mei-2017 - MT
Interventies replaced by:
Primigravida with a gestational age of 20 weeks, pregnant with a singleton were eligible and asked to participate in the study. They were informed about the aims and methods of the study and written informed consent was received. After inclusion, a baseline, pretest questionnaire with close-ended questions and the Cambridge worry scale (CWS) were sent by email. If the questionnaires were not returned within one week the participant received a reminder. First, all participants of the control group were collected and then the intervention group. The women in the intervention group received the information brochure ‘your pregnancy - feeling your baby move’ about fetal movements on their regular pregnancy appointment at gestational age of 24 weeks. At a gestational age of 28 weeks, all women received the second questionnaire. The women in the control group received the information brochure after completing the second questionnaire.
- RECORD31-mrt-2015 - 24-mei-2017


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