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Vaginal Progesterone in Twins With Short Cervix

Primary Purpose

Premature Birth

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vaginal Progesterone gel.
fetal fibronectin swab.
Placebo gel
Sponsored by
Obstetrix Medical Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Birth focused on measuring premature birth, twins, short cervix

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Good Samaritan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vaginal Progesterone

Placebo

Arm Description

Daily administration of Vaginal Progesterone (200mg) Gel between 20 weeks of pregnancy and 34 weeks of pregnancy.

Daily vaginal administration of Placebo gel (Vanicream)between 20 weeks of pregnancy and 34 weeks of pregnancy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Gestational age of baby at birth
measured of the average Gestational age of babies at 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.)
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).

Full Information

First Posted
March 12, 2013
Last Updated
December 17, 2014
Sponsor
Obstetrix Medical Group
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1. Study Identification

Unique Protocol Identification Number
NCT01812239
Brief Title
Vaginal Progesterone in Twins With Short Cervix
Official Title
Vaginal Progesterone to Prevent Early Preterm Birth In Twin Pregnancy With Short Cervix. Double-Blind, Placebo-Controlled, Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Withdrawn
Why Stopped
inability to retain study drug with comparable placebo.
Study Start Date
March 2014 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Obstetrix Medical Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
Keywords
premature birth, twins, short cervix

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vaginal Progesterone
Arm Type
Active Comparator
Arm Description
Daily administration of Vaginal Progesterone (200mg) Gel between 20 weeks of pregnancy and 34 weeks of pregnancy.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Daily vaginal administration of Placebo gel (Vanicream)between 20 weeks of pregnancy and 34 weeks of pregnancy.
Intervention Type
Drug
Intervention Name(s)
Vaginal Progesterone gel.
Other Intervention Name(s)
progestin
Intervention Description
Daily administration of Vaginal Progesterone gel in pregnant women with twins between the 20th week of pregnancy and the 34th week of pregnancy.
Intervention Type
Procedure
Intervention Name(s)
fetal fibronectin swab.
Other Intervention Name(s)
fFN, fibronectin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo gel
Other Intervention Name(s)
placebo
Intervention Description
weekly vaginal administration of the placebo gel from randomization until 34 weeks of gestation.
Primary Outcome Measure Information:
Title
Birth of baby before 34 weeks of gestation
Description
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
Secondary Outcome Measure Information:
Title
Gestational age of baby at birth
Description
measured of the average Gestational age of babies at birth.
Time Frame
measure at time of birth
Title
Rate of "spontaneous birth" before 34weeks of gestation
Description
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
Title
Rate of composite neonatal morbidity
Description
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
Other Pre-specified Outcome Measures:
Title
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.
Description
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.
Time Frame
from the 21st week of gestation until the 25 week of gestation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Combs, MD
Organizational Affiliation
Pediatrix
Official's Role
Principal Investigator
Facility Information:
Facility Name
Good Samaritan Hospital
City
San Jose
State/Province
California
ZIP/Postal Code
95008
Country
United States

12. IPD Sharing Statement

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Vaginal Progesterone in Twins With Short Cervix

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