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Vaginal Progesterone in Twins With Short Cervix

This study has been withdrawn prior to enrollment.
(inability to retain study drug with comparable placebo.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01812239
First Posted: March 18, 2013
Last Update Posted: December 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mednax Center for Research, Education and Quality ( Obstetrix Medical Group )
March 12, 2013
March 18, 2013
December 19, 2014
March 2014
August 2017   (Final data collection date for primary outcome measure)
Birth of baby before 34 weeks of gestation [ Time Frame: 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.
Same as current
Complete list of historical versions of study NCT01812239 on ClinicalTrials.gov Archive Site
  • Gestational age of baby at birth [ Time Frame: measure at time of birth ]
    measured of the average Gestational age of babies at birth.
  • Rate of "spontaneous birth" before 34weeks of gestation [ Time Frame: 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.)
  • Rate of composite neonatal morbidity [ Time Frame: 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).
Same as current
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. [ Time Frame: 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.
Same as current
 
Vaginal Progesterone in Twins With Short Cervix
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.
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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Premature Birth
  • Drug: Vaginal Progesterone gel.
    Daily administration of Vaginal Progesterone gel in pregnant women with twins between the 20th week of pregnancy and the 34th week of pregnancy.
    Other Name: progestin
  • Procedure: fetal fibronectin swab.
    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.
    Other Names:
    • fFN
    • fibronectin
  • Drug: Placebo gel
    weekly vaginal administration of the placebo gel from randomization until 34 weeks of gestation.
    Other Name: placebo
  • Active Comparator: Vaginal Progesterone
    Daily administration of Vaginal Progesterone (200mg) Gel between 20 weeks of pregnancy and 34 weeks of pregnancy.
    Interventions:
    • Drug: Vaginal Progesterone gel.
    • Procedure: fetal fibronectin swab.
  • Placebo Comparator: Placebo
    Daily vaginal administration of Placebo gel (Vanicream)between 20 weeks of pregnancy and 34 weeks of pregnancy.
    Interventions:
    • Procedure: fetal fibronectin swab.
    • Drug: Placebo gel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
August 2018
August 2017   (Final data collection date for primary outcome measure)

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:

    1. fetal malformation likely to require surgery
    2. fetal malformation involving vital organs
    3. fetal viral infection
    4. hydrops fetalis
    5. discordance in estimated fetal weight more than 10%
    6. velamentous insertion of umbilical cord of either twin
    7. placenta previa of either placenta
  • Any contraindication to continuing the pregnancy
  • Cervical cerclage in place or planned
  • Any contraindication to vaginal micronized progesterone, including:

    1. Known sensitivity to progesterone or any of the other ingredients
    2. Liver dysfunction or disease
    3. Known or suspected malignancy of breast or genital organs
    4. Active thromboembolic disorder, or history of hormone-associated thromboembolic disorder
Sexes Eligible for Study: Female
18 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01812239
OBX0019
Yes
Not Provided
Not Provided
Mednax Center for Research, Education and Quality ( Obstetrix Medical Group )
Obstetrix Medical Group
Not Provided
Principal Investigator: Andrew Combs, MD Mednax Center for Research, Education and Quality
Mednax Center for Research, Education and Quality
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP