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Misodel or Angusta for Induction of Labour?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborators:
Naestved Hospital
Zealand University Hospital
Information provided by (Responsible Party):
Holbaek Sygehus

Brief Summary:

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

Show Show detailed description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 420 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. 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.

  2. 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.


  3. 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


Secondary Outcome Measures :
  1. Timeline [ Time Frame: 1,5 year ]
    Number of hours from induction to delivery, daytime delivery

  2. Cost of primary induction method [ Time Frame: 1,5 year ]
    Cost of medication (DKK for primary method of induction ie. Angusta and Misodel)

  3. Experience [ Time Frame: 1,5 year ]
    Patient and midwife - questionnaire based

  4. Staff hours [ Time Frame: 1,5 year ]
    Number of hours with midwife and number of hours admitted in hospital

  5. 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
Study Population
Nulliparous women to term with immature cervix
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • GA < 37+0 weeks, multipara, multiple pregnancy, placenta previa, suspicion of SGA, PROM, and GDM.

Information from the National Library of Medicine

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


Contacts
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Contact: Axelina Eriksson 21137904 axelina87@hotmail.com

Locations
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Denmark
Gynækologisk obstetrisk afdeling Recruiting
Holbæk, Denmark, 4300
Contact: Axelina Eriksson, MD    21137904    axelina87@hotmail.com   
Contact: Lone Krebs, MD, PhD, associate professor         
Sponsors and Collaborators
Holbaek Sygehus
Naestved Hospital
Zealand University Hospital
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Holbaek Sygehus
ClinicalTrials.gov Identifier: NCT02693587    
Other Study ID Numbers: 50213
First Posted: February 26, 2016    Key Record Dates
Last Update Posted: March 3, 2016
Last Verified: February 2016