Misodel or Angusta for Induction of Labour?

• Status: Unknown status
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Holbaek Sygehus
• Collaborators: Naestved Hospital; Zealand University Hospital

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.