Vaginal Progesterone in Twins With Short Cervix

NCT01812239 | Withdrawn Phase 2 DMC

• 1 other identifier: OBX0019
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth

Keywords

premature birth; twins; short cervix

Outcome Measures

Primary Outcomes (1)

• Birth of baby before 34 weeks of gestation

  The primary outcome is defined as Early Preterm Birth, that is, birth before 34weeks of gestation. A birth at 33weeks 6days or earlier is considered to have the primary outcome. A birth at 34weeks 0days or later does not have the primary outcome. Births for any reason before 34weeks 0days are considered to have the primary outcome, whether they are "spontaneous" or not.

  At the time of delivery

Secondary Outcomes (3)

• Gestational age of baby at birth

  measure at time of birth

• Rate of "spontaneous birth" before 34weeks of gestation

  from randomization to birth of the baby - up to 15 weeks

• Rate of composite neonatal morbidity

  measures from randomization to 60 days post delivery of the baby

Other Outcomes (1)

• 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.

  from the 21st week of gestation until the 25 week of gestation

Study Arms (2)

Vaginal Progesterone

ACTIVE COMPARATOR

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

Drug: Vaginal Progesterone gel.; Procedure: fetal fibronectin swab.

Placebo

PLACEBO COMPARATOR

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

Procedure: fetal fibronectin swab.; Drug: Placebo gel

Interventions

Vaginal Progesterone gel. DRUG

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

Also known as: progestin

Vaginal Progesterone

fetal fibronectin swab. 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.

Also known as: fFN, fibronectin

Placebo; Vaginal Progesterone

Placebo gel DRUG

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

Also known as: placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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:

Sponsors & Collaborators

• Obstetrix Medical Group: lead

Study Sites (1)

Good Samaritan Hospital

San Jose, California, 95008, United States

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Progestins; Fibronectins

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Serum Globulins; Globulins; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Extracellular Matrix Proteins; Scleroproteins

Study Officials

• Andrew Combs, MD

  Pediatrix

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2013
• First Posted: March 18, 2013
• Study Start: March 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2018
• Last Updated: December 19, 2014

Record last verified: 2014-12

Locations

US (1)