Vaginal Progesterone in Twins With Short Cervix

Withdrawn before enrolling · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Premature Birth

In brief

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

Key facts

Study ID

NCT01812239

Run by

Obstetrix Medical Group

People needed

0

Starts

2014-03-01

Expected to finish

2018-08-01

Last updated by the study team

2014-12-19

Who can join

Age: 18 and older, up to 60. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Good Samaritan Hospital — San Jose, California, United States

Full record on ClinicalTrials.gov

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