Misodel or Angusta for Induction of Labour? - a Medical Health Technology Assessment
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 420
- Locations
- 1
- Primary Endpoint
- Delivery within 24 hours
Study Overview
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.
Detailed Description
Background The incidence of induced labour in Denmark, has increased from 12% in year 2000 to 25%, in 2014.
This increase is primarily due to a policy of earlier induction in women with prolonged pregnancy expected to decrease the risk of intrauterine fetal death. The national guidelines were changed in 2012.
Aim of the study To compare a regimen with use of 25 mcg peroral misoprostol (Angusta®) to 200 mcg vaginal insert Misoprostol (Misodel®) in a population of nullipara with unripened cervix. The regimens are compared in terms of technology (efficacy and safety), organisation, economy and patient-satisfaction.
Patients:
In the region of Zeeland, there are 6360 births annually, and among these 1636 (25%) births are induced. Among primipara there were 493 (29%) inductions in 2013. The number covers all induced births, i.e. medically, balloon-catheter, and amniotomy. In Holbæk Hospital (2013), 373 women were induced and among these 190 were primipara. In Næstved Hospital the number of inductions were 393 and 177 were primipara.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Misodel group in Holbæk
Misodel for induction of labour in Holbæk
Intervention: Misodel and Angusta (Drug)
Angusta group in Roskilde and Næstved
Angusta for induction of labour in Roskilde and Næstved
Intervention: Misodel and Angusta (Drug)
Outcomes
Primary Outcomes
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
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.
Secondary Outcomes
- Timeline(1,5 year)
- Cost of primary induction method(1,5 year)
- Experience(1,5 year)
- Staff hours(1,5 year)
- Additional medications/treatments cost(1,5 year)