Vaginal Progesterone in Twins With Short Cervix (no)

This study has been withdrawn prior to enrollment.
(inability to retain study drug with comparable placebo.)
Sponsor:
Information provided by (Responsible Party):
Obstetrix Medical Group
ClinicalTrials.gov Identifier:
NCT01812239
First received: March 12, 2013
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

A Multicenter, Double-Blind, Placebo-Controlled Randomized Clinical Trial of Vaginal Progesterone to Prevent Early Preterm Birth In Twin Pregnancy with Short Cervix.


Condition Intervention Phase
Premature Birth
Drug: Vaginal Progesterone gel.
Procedure: fetal fibronectin swab.
Drug: Placebo gel
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Vaginal Progesterone to Prevent Early Preterm Birth In Twin Pregnancy With Short Cervix. Double-Blind, Placebo-Controlled, Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Obstetrix Medical Group:

Primary Outcome Measures:
  • Birth of baby before 34 weeks of gestation [ Time Frame: At the time of delivery ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Gestational age of baby at birth [ Time Frame: measure at time of birth ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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).


Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 0
Study Start Date: March 2014
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vaginal Progesterone
Daily administration of Vaginal Progesterone (200mg) Gel between 20 weeks of pregnancy and 34 weeks of pregnancy.
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
Placebo Comparator: Placebo
Daily vaginal administration of Placebo gel (Vanicream)between 20 weeks of pregnancy and 34 weeks of pregnancy.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01812239

Locations
United States, California
Good Samaritan Hospital
San Jose, California, United States, 95008
Sponsors and Collaborators
Obstetrix Medical Group
Investigators
Principal Investigator: Andrew Combs, MD Pediatrix Medical Group
  More Information

No publications provided

Responsible Party: Obstetrix Medical Group
ClinicalTrials.gov Identifier: NCT01812239     History of Changes
Other Study ID Numbers: OBX0019
Study First Received: March 12, 2013
Last Updated: April 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Obstetrix Medical Group:
premature birth
twins
short cervix

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Progestins
Progesterone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014