Preterm Delivery Prevention in Twins With Progesterone | NCT01927029

Studies
Preterm Delivery Prevention in Twins With Progesterone

NCT01927029

Sponsor

Universidad del Desarrollo

Status

Unknown status

Last Update Posted

Aug 21, 2013Estimated

Enrollment

213Actual

Phase

Phase 4

Conditions

Pregnancies

Interventions

Progesterone
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Oct 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Aug 19, 2013

First Submission Date that Met QC Criteria

Aug 20, 2013

First Posted Date

Aug 21, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2013

Last Update Posted Date

Aug 21, 2013Estimated

Name	Class
Hospital Padre Hurtado	OTHER
Hospital San Borja-Arriaran	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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%.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

213Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Progesterone	Drug	Vaginal progesterone gel 180mg/daily is given from second trimester (18 to 24 weeks) until 34 weeks.	Progesterone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Preterm delivery <34 weeks	Spontaneous labor under 34 weeks.	14 months

Secondary Outcomes

Measure	Description	Time Frame
Preterm delivery <37 weeks	Spontaneous delivery under 37 weeks	14 months

Other Outcomes

Measure	Description	Time Frame
Neonatal mortality	Dead of the newborn, due to preterm delivery	14 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Monochorionic or Dichorionic twin pregnancies
18 weeks to 24 weeks at inclusion.

Exclusion Criteria:

Cerclage before inclusion
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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth
D005330	Fetofetal Transfusion

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011374	Progesterone

Ancestor Terms

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided