Misodel or Angusta for Induction of Labour?
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|ClinicalTrials.gov Identifier: NCT02693587|
Recruitment Status : Unknown
Verified February 2016 by Holbaek Sygehus.
Recruitment status was: Recruiting
First Posted : February 26, 2016
Last Update Posted : March 3, 2016
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In Denmark, every 4 birth induced, most often due to prolonged pregnancy, up til 10-12 days after term. A group (RADS) set up by the Danish Regions has recently recommended induction with prostaglandins in tablet form (Angusta®). The recommendation is based primarily on the results of a meta-analysis published by the Cochrane Library, where various prostaglandin medications were compared.
Vaginal prostaglandin insert (Misodel®) have proved safe in American Studies and is registered in Denmark for use of induction. Misodel® was not included in RADS's evaluation, as there are only few studies on the effectiveness and side effects.
In the current study, investigators want to compare two different regimes for the induction of primipara who use respectively Misodel® and Angusta® as the primary method. The study is based on prospective collection of data from three divisions in Region Zealand, where investigators primarily compare the efficacy and safety but also to evaluate women's experience, the cost of medicine and consumption of resources in the maternity wards.
|Condition or disease||Intervention/treatment|
|Safety Efficacy Cost Experience||Drug: Misodel and Angusta|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||420 participants|
|Target Follow-Up Duration:||1 Week|
|Official Title:||Misodel or Angusta for Induction of Labour? - a Medical Health Technology Assessment|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||June 2017|
Misodel group in Holbæk
Misodel for induction of labour in Holbæk
Drug: Misodel and Angusta
Angusta group in Roskilde and Næstved
Angusta for induction of labour in Roskilde and Næstved
Drug: Misodel and Angusta
- Frequency of caesarean section [ Time Frame: 1,5 year ]No of patients with caesarean section, will be registered for every patient, in their chart after birth, and assessed after 1,5 year.
- Hyperstimulation [ Time Frame: 1,5 year ]
No of patients with hyperstimulation will be registered in the patient chart and assessed after 1,5 year.
Defined as tachysystoly with > 5 contractions in 10 minutes over a period of 30 minutes. Indeterminate or abnormal CTG. Scalp-pH < 7,20 or umbilical cord pH < 7,10.
- Delivery within 24 hours [ Time Frame: 1,5 year ]Number of patients with delivery within 24 hours after induction, will be registered in the patient chart, and assessed after 1,5 year
- Timeline [ Time Frame: 1,5 year ]Number of hours from induction to delivery, daytime delivery
- Cost of primary induction method [ Time Frame: 1,5 year ]Cost of medication (DKK for primary method of induction ie. Angusta and Misodel)
- Experience [ Time Frame: 1,5 year ]Patient and midwife - questionnaire based
- Staff hours [ Time Frame: 1,5 year ]Number of hours with midwife and number of hours admitted in hospital
- Additional medications/treatments cost [ Time Frame: 1,5 year ]Price in DKK for additional medications or treatments for induction ie. oxytocin and ballon catheter
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|Ages Eligible for Study:||18 Years to 50 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Primipara, immature cervix (Bishop score < 4), gestational age > 37+0 weeks with a singleton pregnancy without suspicion of fetal growth retardation (SGA defined as birth-weight deviation ≤-22%), and no history of prelabor rupture of membranes (PROM). No GDM.
- GA < 37+0 weeks, multipara, multiple pregnancy, placenta previa, suspicion of SGA, PROM, and GDM.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02693587
|Contact: Axelina Erikssonfirstname.lastname@example.org|
|Gynækologisk obstetrisk afdeling||Recruiting|
|Holbæk, Denmark, 4300|
|Contact: Axelina Eriksson, MD 21137904 email@example.com|
|Contact: Lone Krebs, MD, PhD, associate professor|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Holbaek Sygehus|
|Other Study ID Numbers:||
|First Posted:||February 26, 2016 Key Record Dates|
|Last Update Posted:||March 3, 2016|
|Last Verified:||February 2016|