Clinical trial NCT01812239: 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
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Premature Birth
Keywords: premature birth
twins
short cervix
Lead sponsor: Pediatrix
Sponsor class: OTHER
First posted: 2013-03-18
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

  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

Primary outcomes:
measure: Birth of baby before 34 weeks of gestation
timeFrame: At the time of delivery
Secondary outcomes:
measure: Gestational age of baby at birth
timeFrame: measure at time of birth
measure: Rate of "spontaneous birth" before 34weeks of gestation
timeFrame: from randomization to birth of the baby - up to 15 weeks
measure: Rate of composite neonatal morbidity
timeFrame: measures from randomization to 60 days post delivery of the baby
Other outcomes:
measure: 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.
timeFrame: from the 21st week of gestation until the 25 week of gestation
Locations:
city: San Jose
country: United States
facility: Good Samaritan Hospital
state: California
Study officials:
affiliation: Pediatrix
name: Andrew Combs, MD
role: PRINCIPAL_INVESTIGATOR
References: