NCT01927029

Brief Summary

Twin pregnancies have very high preterm delivery rate. Until now, no RCT has proven benefit of progesterone in this population. In contrast, singleton pregnancies are treated with this hormone. The objective is to compare 180mg/day progeterone vaginal gel with 180mg/day with placebo, from 18 weeks to 34 weeks. The sample size was calculated and 213 cases in each group are needed to demonstrate a reduction of preterm delivery \<34weeks from 13% to 7%.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
213

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2013

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 21, 2013

Status Verified

August 1, 2013

Enrollment Period

1.2 years

First QC Date

August 19, 2013

Last Update Submit

August 20, 2013

Conditions

Pregnancies

Keywords

twin pregnancyprogesteronepreterm delivery>14 yearsAbscense of cerclage,TTTS, hemorrage,history of thrombosis.cervix >15mm

Outcome Measures

Primary Outcomes (1)

  • Preterm delivery <34 weeks

    Spontaneous labor under 34 weeks.

    14 months

Secondary Outcomes (1)

  • Preterm delivery <37 weeks

    14 months

Other Outcomes (1)

  • Neonatal mortality

    14 months

Study Arms (2)

Progesterone

EXPERIMENTAL

Daily administration of vaginal progesterone, 180mg, in gel, from 18 weeks to 34 weeks.

Drug: Progesterone

Placebo

PLACEBO COMPARATOR

Placebo Gel, for daily use from 18 weeks to 34 weeks.

Drug: Placebo

Interventions

ProgesteroneDRUG

Vaginal progesterone gel 180mg/daily is given from second trimester (18 to 24 weeks) until 34 weeks.

Also known as: Progendo gel
Progesterone
PlaceboDRUG
Placebo

Eligibility Criteria

Age14 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Monochorionic or Dichorionic twin pregnancies

You may not qualify if:

  • Contractions, rupture of the membranes, cervix dilation,
  • Short cervix (15mm or 20mm if there is history of preterm delivery
  • Monoamniotic twins, Major malformation, Selective IUGR, TRAP, TTTS.
  • Younger than 14 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Premature BirthFetofetal Transfusion

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesAnemia, NeonatalAnemiaHematologic DiseasesHemic and Lymphatic DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 19, 2013

First Posted

August 21, 2013

Study Start

August 1, 2013

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

August 21, 2013

Record last verified: 2013-08