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Vaginal Progesterone in Twins With Short Cervix

Information source: Mednax Center for Research, Education and Quality
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Premature Birth

Intervention: Vaginal Progesterone gel. (Drug); fetal fibronectin swab. (Procedure); Placebo gel (Drug)

Phase: Phase 2/Phase 3

Status: Withdrawn

Sponsored by: Obstetrix Medical Group

Official(s) and/or principal investigator(s):
Andrew Combs, MD, Principal Investigator, Affiliation: Mednax Center for Research, Education and Quality


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

Clinical Details

Official title: Vaginal Progesterone to Prevent Early Preterm Birth In Twin Pregnancy With Short Cervix. Double-Blind, Placebo-Controlled, Randomized Clinical Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Birth of baby before 34 weeks of gestation

Secondary outcome:

Gestational age of baby at birth

Rate of "spontaneous birth" before 34weeks of gestation

Rate of composite neonatal morbidity

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.


Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Female.


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

Locations and Contacts

Good Samaritan Hospital, San Jose, California 95008, United States
Additional Information

Starting date: March 2014
Last updated: December 17, 2014

Page last updated: August 23, 2015

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