- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01812239
Vaginal Progesterone in Twins With Short Cervix
17. december 2014 opdateret af: Obstetrix Medical Group
Vaginal Progesterone to Prevent Early Preterm Birth In Twin Pregnancy With Short Cervix. Double-Blind, Placebo-Controlled, Randomized Clinical Trial
A Multicenter, Double-Blind, Placebo-Controlled Randomized Clinical Trial of Vaginal Progesterone to Prevent Early Preterm Birth In Twin Pregnancy with Short Cervix.
Studieoversigt
Status
Trukket tilbage
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a placebo-controlled, double-blind, randomized clinical trial of asymptomatic women with twin pregnancy and a cervix length 10 mm to 25 mm discovered on a routine screening transvaginal sonogram between 20w0d to 24w0d gestational age.
Women will be randomized in either the in-patient or out-patient setting (1:1) to a daily vaginal application of micronized progesterone cream(200 mg)vs.
placebo to determine if daily vaginal progesterone administration reduces the risk of preterm birth prior to 34w0d of gestation.
Undersøgelsestype
Interventionel
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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California
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San Jose, California, Forenede Stater, 95008
- Good Samaritan Hospital
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-
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 60 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- Gestational age between 20w0d and 24w0d
- Twin pregnancy, diamniotic-dichorionic, both twins living
- Cervical length 10 mm to 25 mm discovered by a screening transvaginal ultrasound exam
Exclusion Criteria:
- Mother less than 18 years of age
- Uterine contractions of 40 seconds duration or more, 10 or more per hour
- Rupture of fetal membranes (leakage of amniotic fluid one or both sacs)
- Ongoing vaginal bleeding
Any condition likely to cause serious neonatal morbidity independent of gestational age, including:
- fetal malformation likely to require surgery
- fetal malformation involving vital organs
- fetal viral infection
- hydrops fetalis
- discordance in estimated fetal weight more than 10%
- velamentous insertion of umbilical cord of either twin
- placenta previa of either placenta
- Any contraindication to continuing the pregnancy
- Cervical cerclage in place or planned
Any contraindication to vaginal micronized progesterone, including:
- Known sensitivity to progesterone or any of the other ingredients
- Liver dysfunction or disease
- Known or suspected malignancy of breast or genital organs
- Active thromboembolic disorder, or history of hormone-associated thromboembolic disorder
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: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Vaginal Progesterone
Daily administration of Vaginal Progesterone (200mg) Gel between 20 weeks of pregnancy and 34 weeks of pregnancy.
|
Daily administration of Vaginal Progesterone gel in pregnant women with twins between the 20th week of pregnancy and the 34th week of pregnancy.
Andre navne:
Collection of quantatative fetal fibronectin swab one week after randomization into the trial for both arms.
Randomziation occurs between 20 weeks - 24 weeks of gestation.
Andre navne:
|
Placebo komparator: Placebo
Daily vaginal administration of Placebo gel (Vanicream)between 20 weeks of pregnancy and 34 weeks of pregnancy.
|
Collection of quantatative fetal fibronectin swab one week after randomization into the trial for both arms.
Randomziation occurs between 20 weeks - 24 weeks of gestation.
Andre navne:
weekly vaginal administration of the placebo gel from randomization until 34 weeks of gestation.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Birth of baby before 34 weeks of gestation
Tidsramme: At the time of delivery
|
The primary outcome is defined as Early Preterm Birth, that is, birth before 34weeks of gestation.
A birth at 33weeks 6days or earlier is considered to have the primary outcome.
A birth at 34weeks 0days or later does not have the primary outcome.
Births for any reason before 34weeks 0days are considered to have the primary outcome, whether they are "spontaneous" or not.
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At the time of delivery
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Gestational age of baby at birth
Tidsramme: measure at time of birth
|
measured of the average Gestational age of babies at birth.
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measure at time of birth
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Rate of "spontaneous birth" before 34weeks of gestation
Tidsramme: from randomization to birth of the baby - up to 15 weeks
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Rate of "spontaneous birth" before 34weeks of gestation.
Spontaneous births are those whose underlying cause is judged to be due to preterm labor, prelabor rupture of membranes, or cervical insufficiency.
(In contradistinction, "indicated" deliveries are those due to preeclampsia, fetal growth problems, fetal heart rate abnormalities, and other problems.)
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from randomization to birth of the baby - up to 15 weeks
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Rate of composite neonatal morbidity
Tidsramme: measures from randomization to 60 days post delivery of the baby
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Composite morbidity is defined as any one or more of: stillbirth, neonatal death, infant death before hospital discharge, respiratory distress syndrome (RDS), intracranial hemorrhage (grade 3 or 4)(IVH), necrotizing enterocolitis (stage 2 or 3)(NEC), documented neonatal sepsis within 72 hr of birth, or periventricular leukomalacia (characteristic lesions in the subcortical white matter seen on cerebral imaging studies within 96 hrs of birth)(PVL).
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measures from randomization to 60 days post delivery of the baby
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Comparison of effectiveness of progesterone in women in highest 2 quartiles of quantitative fetal fibronectin (fFN) versus those in the lowest 2 quartiles of quantitative fFN.
Tidsramme: from the 21st week of gestation until the 25 week of gestation
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A cervicovaginal swab for quantitative fetal fibronectin testing will be obtained at the first antenatal visit, approximately 1 week after enrollment.
The results of this will be used to test a secondary hypothesis that fFN levels will identify a subgroup of participants who respond to progesterone treatment and another subgroup who do not.
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from the 21st week of gestation until the 25 week of gestation
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Andrew Combs, MD, Mednax Center for Research, Education, Quality and Safety
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
1. marts 2014
Primær færdiggørelse (Forventet)
1. august 2017
Studieafslutning (Forventet)
1. august 2018
Datoer for studieregistrering
Først indsendt
12. marts 2013
Først indsendt, der opfyldte QC-kriterier
15. marts 2013
Først opslået (Skøn)
18. marts 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
19. december 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. december 2014
Sidst verificeret
1. december 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- OBX0019
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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