Vaginal Progesterone in Twins With Short Cervix

NCT ID: NCT01812239

Last Updated: 2014-12-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2018-08-31

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.

Conditions

Premature Birth

Keywords

premature birth; twins; short cervix

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Vaginal Progesterone

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

Group Type: ACTIVE_COMPARATOR

Vaginal Progesterone gel.

Intervention Type: DRUG

Daily administration of Vaginal Progesterone gel in pregnant women with twins between the 20th week of pregnancy and the 34th week of pregnancy.

fetal fibronectin swab.

Intervention Type: PROCEDURE

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.

Placebo

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

Group Type: PLACEBO_COMPARATOR

fetal fibronectin swab.

Intervention Type: PROCEDURE

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.

Placebo gel

Intervention Type: DRUG

weekly vaginal administration of the placebo gel from randomization until 34 weeks of gestation.

Interventions

Vaginal Progesterone gel.

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: DRUG

fetal fibronectin swab.

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: PROCEDURE

Placebo gel

weekly vaginal administration of the placebo gel from randomization until 34 weeks of gestation.

Intervention Type: DRUG

Other Intervention Names

progestin; fFN; fibronectin; placebo

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Obstetrix Medical Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Combs, MD

Role: PRINCIPAL_INVESTIGATOR

Pediatrix

Locations

Good Samaritan Hospital

San Jose, California, United States

Countries

United States

Other Identifiers

OBX0019

Identifier Type: -

Identifier Source: org_study_id