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Preterm Delivery Prevention in Twins With Progesterone

NCT ID: NCT01927029

Last Updated: 2013-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

213 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Pregnancies

Keywords

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twin pregnancy progesterone preterm delivery >14 years Abscense of cerclage, TTTS, hemorrage, history of thrombosis. cervix >15mm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Progesterone

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

Group Type EXPERIMENTAL

Progesterone

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Progesterone

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

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Progendo gel

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital Padre Hurtado

OTHER

Sponsor Role collaborator

Hospital San Borja-Arriaran

OTHER

Sponsor Role collaborator

Universidad del Desarrollo

OTHER

Sponsor Role lead

Responsible Party

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Masami Yamamoto

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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CAS149

Identifier Type: -

Identifier Source: org_study_id