NCT02693587

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
420

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 26, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

March 3, 2016

Status Verified

February 1, 2016

Enrollment Period

1.6 years

First QC Date

November 9, 2015

Last Update Submit

March 2, 2016

Conditions

SafetyEfficacyCostExperience

Outcome Measures

Primary Outcomes (3)

  • Frequency of caesarean section

    No of patients with caesarean section, will be registered for every patient, in their chart after birth, and assessed after 1,5 year.

    1,5 year

  • Hyperstimulation

    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.

    1,5 year

  • Delivery within 24 hours

    Number of patients with delivery within 24 hours after induction, will be registered in the patient chart, and assessed after 1,5 year

    1,5 year

Secondary Outcomes (5)

  • 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

Study Arms (2)

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

Interventions

Misodel and AngustaDRUG
Angusta group in Roskilde and NæstvedMisodel group in Holbæk

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Nulliparous women to term with immature cervix

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynækologisk obstetrisk afdeling

Holbæk, 4300, Denmark

RECRUITING

Related Publications (2)

  • Hansen KH, Eriksson A, Jeppesen S, Jeppegaard M, Krebs L. Women's experiences of induction of labour with misoprostol tablets compared with vaginal insert. Dan Med J. 2023 Jan 24;70(2):A04220232.

    PMID: 36892220DERIVED

  • Eriksson A, Jeppesen S, Krebs L. Induction of labour in nulliparous women- quick or slow: a cohort study comparing slow-release vaginal insert with low-dose misoprostol oral tablets. BMC Pregnancy Childbirth. 2020 Feb 7;20(1):79. doi: 10.1186/s12884-020-2770-0.

    PMID: 32033600DERIVED

Central Study Contacts

Axelina Eriksson

CONTACT

21137904axelina87@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2015

First Posted

February 26, 2016

Study Start

November 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

March 3, 2016

Record last verified: 2016-02

Locations

DK(1)