Vaginal Progesterone in Twins With Short Cervix
17 december 2014 uppdaterad av: 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.
Studieöversikt
Status
Indragen
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Fas
- Fas 2
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
California
-
San Jose, California, Förenta staterna, 95008
- Good Samaritan Hospital
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 60 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / 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.
Andra namn:
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.
Andra namn:
|
|
Placebo-jämförare: 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.
Andra namn:
weekly vaginal administration of the placebo gel from randomization until 34 weeks of gestation.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Birth of baby before 34 weeks of gestation
Tidsram: 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.
|
At the time of delivery
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Gestational age of baby at birth
Tidsram: measure at time of birth
|
measured of the average Gestational age of babies at birth.
|
measure at time of birth
|
|
Rate of "spontaneous birth" before 34weeks of gestation
Tidsram: from randomization to birth of the baby - up to 15 weeks
|
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.)
|
from randomization to birth of the baby - up to 15 weeks
|
|
Rate of composite neonatal morbidity
Tidsram: measures from randomization to 60 days post delivery of the baby
|
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).
|
measures from randomization to 60 days post delivery of the baby
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
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.
Tidsram: from the 21st week of gestation until the 25 week of gestation
|
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.
|
from the 21st week of gestation until the 25 week of gestation
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Andrew Combs, MD, Mednax Center for Research, Education, Quality and Safety
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2014
Primärt slutförande (Förväntat)
1 augusti 2017
Avslutad studie (Förväntat)
1 augusti 2018
Studieregistreringsdatum
Först inskickad
12 mars 2013
Först inskickad som uppfyllde QC-kriterierna
15 mars 2013
Första postat (Uppskatta)
18 mars 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
19 december 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 december 2014
Senast verifierad
1 december 2014
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- OBX0019
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