Status:
WITHDRAWN
Vaginal Progesterone in Twins With Short Cervix
Lead Sponsor:
Obstetrix Medical Group
Conditions:
Premature Birth
Eligibility:
FEMALE
18-60 years
Phase:
PHASE2
PHASE3
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 sonogr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01812239
Start Date
March 1 2014
End Date
August 1 2018
Last Update
December 19 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Good Samaritan Hospital
San Jose, California, United States, 95008