Low-dose Vaginal Misoprostol Versus Vaginal Dinoprostone Insert for Induction of Labor (MADUTER)
15. november 2018 opdateret af: Jose Manuel Campillos Maza, Hospital Miguel Servet
Low-dose Vaginal Misoprostol Versus Vaginal Dinoprostone Insert for Induction of Labor Beyond 41st Week: a Randomized Trial
Purpose:
To compare the efficacy and safety of low-dose protocol of vaginal misoprostol and vaginal dinoprostone insert for induction of labor in women with post-term pregnancies.
Methods:
The investigators designed a prospective, randomized, open-labeled, blinded for the end-point evaluators trial including women of at least 41 weeks of gestational age with uncomplicated singleton pregnancies and Bishop score lower than 6. Participants were randomized into dinoprostone or misoprostol groups in a 1:1 ratio. Baseline maternal data and perinatal outcomes were recorded for statistical analysis. Successful vaginal delivery within 24 hours was the primary outcome variable.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
198
Fase
- Fase 4
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 50 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- Singleton uncomplicated pregnancy
- Nulliparity
- Live fetus
- 286 days of gestational age or above
- Abscence of contraindication for vaginal delivery
- Bishop score lower than 6
Exclusion Criteria:
- Multiple pregnancy
- Multiparity
- Stillbirth
- Oligohydramnios
- Suspected fetal distress
- Severe asthma
- Intolerance/allergy to prostaglandins
- Contraindication for vaginal birth
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Misoprostol
Group of women allocated to misoprostol induction.
|
To determine efficacy and safety of vaginal 'Misoprostol 25 mcg' every 4 hours with a maximum of 6 doses for induction of labor.
Andre navne:
|
|
Aktiv komparator: Dinoprostone
Group of women allocated to dinoprostone induction.
|
To determine efficacy and safety of 'Dinoprostone 10mg' vaginal insert for induction of labor.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Successful vaginal delivery within 24 hours
Tidsramme: 24 hours since induction was started
|
Percentage of women that achieve a vaginal delivery within 24 hours since induction process started
|
24 hours since induction was started
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Successful cervical ripening within 24 hours
Tidsramme: 24 hours since induction was started
|
Percentage of women that achieve Bishop score > 6 within 24 hours since induction process started
|
24 hours since induction was started
|
|
Interval time from induction to delivery
Tidsramme: Hours passed between induction of labor until delivery within 72 hours
|
Time passed since induction of labor started until delivery
|
Hours passed between induction of labor until delivery within 72 hours
|
|
Need for a second induction
Tidsramme: Assessed 24 hours since induction of labor was started
|
Percentage of women that require to use a second method for induction of labor after 24 hours of having started induction of labor
|
Assessed 24 hours since induction of labor was started
|
|
Vaginal delivery rate
Tidsramme: Since labor induction had started until delivery had ocurred within 72 hours
|
Percentage of women that achieve vaginal delivery
|
Since labor induction had started until delivery had ocurred within 72 hours
|
Samarbejdspartnere og efterforskere
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Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juni 2014
Primær færdiggørelse (Faktiske)
20. oktober 2017
Studieafslutning (Faktiske)
1. november 2017
Datoer for studieregistrering
Først indsendt
9. november 2018
Først indsendt, der opfyldte QC-kriterier
15. november 2018
Først opslået (Faktiske)
16. november 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. november 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. november 2018
Sidst verificeret
1. november 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- JMC-PGE-2014-01
Plan for individuelle deltagerdata (IPD)
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