|- candidate number||21891|
|- NTR Number||NTR5127|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||31-mrt-2015|
|- Secondary IDs||15-N-36 |
|- Public Title||Reduction of delayed reporting of reduced fetal movements with the introduction of information about fetal movements.
|- Scientific Title||Patient delay at reduced fetal movements|
|- hypothesis||The 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) studied||Reduced fetal movements, Patient delay|
|- Inclusion criteria||- singleton pregnancy
- +/- 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 received||yes|
|- multicenter trial||no|
|- planned startdate ||7-apr-2015|
|- planned closingdate||1-mrt-2016|
|- Target number of participants||200|
|- Interventions||Stepped 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 outcome||patient delay|
|- Secondary outcome||knowledge of fetal movements
|- Timepoints||AD 24weeks
AD 28 weeks|
|- Trial web site|
|- 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|
(Source(s) of Monetary or Material Support)
|- 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.
|- RECORD||31-mrt-2015 - 24-mei-2017|