Trials Sponsors Conditions Drugs Pricing

Conditions

Short Cervical Length

Keywords

womencervical length of less than 30 millimeterscarrying twinsshort cervix

Outcome Measures

Primary Outcomes (1)

Number of Participants With Delivery or Fetal Loss of Either Twin Prior to 35 Weeks Gestation
Number of Participants who had preterm delivery or fetal loss of either twin prior to 35 weeks gestation
From randomization to 35 weeks gestation (a period of up to 19 weeks)

Secondary Outcomes (15)

Days From Randomization to Delivery (or Fetal Demise)
Randomization to delivery (a period of up to 26 weeks)
Gestational Age at Delivery or Fetal Death
Randomization to delivery (a period of up to 26 weeks)
Number of Participants With Preterm Delivery or Fetal Demise of Either Twin Prior to 28 Weeks Gestation
From randomization to up to 28 weeks gestation (a period if up to 12 weeks)
Number of Participants With Preterm Delivery or Fetal Demise of Either Twin Prior to 32 Weeks Gestation
From randomization to 32 weeks gestation (a period of up to 16 weeks)
Number of Participants With Preterm Delivery or Fetal Demise of Either Twin Prior to 37 Weeks Gestation
randomization to 37 weeks gestation (a period of up to 21 weeks)
+10 more secondary outcomes

Other Outcomes (1)

Number of Participants With Delivery or Fetal Loss of Either Twin Prior to 35 Weeks Gestation by Race/Ethnicity
From randomization to 35 weeks gestation (a period of up to 19 weeks)

Study Arms (3)

Progesterone

ACTIVE COMPARATOR

vaginal progesterone capsule

Drug: Vaginal progesterone

Placebo

PLACEBO COMPARATOR

placebo capsule

Drug: Placebo

Arabin Pessary

ACTIVE COMPARATOR

Arabin Pessary

Device: Arabin Pessary

Interventions

Vaginal progesteroneDrug

200mg micronized vaginal progesterone softgel capsule, daily from randomization to \< 35 wks

Also known as: Prometrium

Progesterone

PlaceboDrug

placebo softgel capsule, daily from randomization to \< 35 wks

Placebo

Eligibility Criteria

Sexfemale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Twin gestation with cardiac activity in both fetuses. Higher order multifetal gestations reduced to twins, either spontaneously or therapeutically, are not eligible unless the reduction occurred by 13 weeks 6 days project gestational age.
Gestational age at randomization between 16 weeks 0 days and 23 weeks 6 days based on clinical information and evaluation of the earliest ultrasound.

Sponsors & Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIHcollaborator
The George Washington University Biostatistics Center
Otherlead

Study Sites (16)

University of Alabama - Birmingham

Birmingham, Alabama, 35294, United States

The Regents of the University of California, San Francisco

San Francisco, California, United States

University of Colorado

Denver, Colorado, 80045, United States

Northwestern University-Prentice Hospital

Chicago, Illinois, 60611, United States

Columbia University

New York, New York, 10032, United States

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Duke University

MeSH Terms

Interventions

Progesterone

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Results Point of Contact

Title: Joseph Biggio, MD, MS
Organization: Ochsner Health

Study Officials

Joseph Biggio, MD
Maternal Fetal Medicine Units (MFMU) Network
STUDY CHAIR
Monica Longo, MD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

1,311 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details: Participants and care providers will be blinded to active study drug vs. placebo.
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 18, 2015

First Posted

August 10, 2015

You may not qualify if:

Monoamniotic gestation, due to increased risk of adverse pregnancy outcome
Twin-twin transfusion syndrome, due to increased risk of adverse pregnancy outcome
Evidence of severe IUGR (intrauterine growth restriction) (\<5th percentile for gestational age) in either fetus
Fetal anomaly in either twin or imminent fetal demise. This includes lethal anomalies, or anomalies that may lead to early delivery or increased risk of neonatal death e.g., gastroschisis, spina bifida, serious karyotypic abnormalities). An ultrasound examination from 14 weeks 0 days to 23 weeks 6 days by project EDC (estimated date of conception) must be performed prior to randomization to evaluate the fetuses for anomalies.
Placenta previa, because of risk of bleeding and high potential for indicated preterm birth
Active vaginal bleeding greater than spotting at the time of randomization, because of potential exacerbation due to pessary placement.
Symptomatic, untreated vaginal or cervical infection, also because of potential exacerbation due to pessary placement. Patients may be treated and if subsequently asymptomatic, randomized.
Rupture of membranes due to likelihood of pregnancy loss and preterm delivery as well as the risk of ascending infection which could be increased with pessary placement
More than six contractions per hour reported or documented prior to randomization. It is not necessary to place the patient on a tocodynamometer
Known major Mullerian anomaly of the uterus (specifically bicornuate, unicornuate, or uterine septum not resected) due to increased risk of preterm delivery which is unlikely to be affected by progesterone
Any fetal/maternal condition which would require invasive in-utero assessment or treatment, for example significant red cell antigen sensitization or neonatal alloimmune thrombocytopenia
Planned cerclage or cerclage already in place since it would preclude placement of a pessary
Planned indicated delivery prior to 35 weeks
Planned or actual progesterone treatment of any type or form after 15 weeks 6 days during the current pregnancy
Allergy to progesterone, silicone, or excipients in the study drug, including peanuts or peanut oil in the study drug or placebo
+5 more criteria

A Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (15)

Other Outcomes (1)

Study Arms (3)

Progesterone

Placebo

Arabin Pessary

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (16)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

A Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (15)

Other Outcomes (1)

Study Arms (3)

Progesterone

Placebo

Arabin Pessary

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (16)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations