A Multicenter, Double-Blind, Placebo-Controlled Randomized Clinical Trial of Vaginal Progesterone to Prevent Early Preterm Birth In Twin Pregnancy with Short Cervix.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Daily administration of Vaginal Progesterone gel in pregnant women with twins between the 20th week of pregnancy and the 34th week 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.
weekly vaginal administration of the placebo gel from randomization until 34 weeks of gestation.
Good Samaritan Hospital
San Jose, California, United States
Birth of baby before 34 weeks of gestation
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.
Time frame: At the time of delivery
Gestational age of baby at birth
measured of the average Gestational age of babies at birth.
Time frame: measure at time of birth
Rate of "spontaneous birth" before 34weeks of gestation
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.)
Time frame: from randomization to birth of the baby - up to 15 weeks
Rate of composite neonatal morbidity
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).
Time frame: measures from randomization to 60 days post delivery of the baby
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