Vaginal PROgesterone as Maintenance Treatment After an epISode of prEterm Labor (PROMISE Study)

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

265 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2012-05-31

Brief Summary

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Eligible patients will be informed and asked to enroll in the study at hospital admission. A transvaginal ultrasound examination will be performed to determine cervical length. If an eligible woman accepts to participate, patient will be randomized to one of the study arms assigned in a double blind basis. Patient will receive the medication (vaginal capsule of progesterone or placebo). The patient will administer herself one vaginal capsule in a daily basis since gestational age of 36 weeks and 6 days as the primary endpoint is to demonstrate that the use of a maintenance treatment with vaginal progesterone is able to reduce the incidence of preterm birth before 34.0 and 37.0 gestational weeks. After delivery, perinatal and neonatal data will be collected.

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Detailed Description

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Conditions

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Threatened Premature Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Progesterone 200 mg

Group Type ACTIVE_COMPARATOR

Progesterone

Intervention Type DRUG

1 vaginal capsule, 200 mg, once daily since gestation age 36 weeks and 6 days

B

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 vaginal capsule, once daily since gestational age of 36 weeks and 6 days

Interventions

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Progesterone

1 vaginal capsule, 200 mg, once daily since gestation age 36 weeks and 6 days

Intervention Type DRUG

Placebo

1 vaginal capsule, once daily since gestational age of 36 weeks and 6 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Pregnant women aged between 18 - 45 years
* Gestational age between 24.0 and before 33.6 gestational weeks
* Singleton pregnancy
* Patients admitted because of preterm labor who have been successfully treated of any tocolytic drugs (β-mimetics drugs, nifedipine, atosiban)
* Ultrasound cervical length at discharge \< 25 mm
* Signed patient consent form (CI)

Exclusion Criteria

* Known or suspected infection, premature rupture of membranes or any other pathological gravid maternal or fetal condition coexisting at hospital admission (Pre-eclampsia, RCIU) which may induce iatrogenic labor.
* Present or previous liver disease, present or previous cholestasis gravidarum, abnormal hepatic blood tests.
* With known allergy to progesterone or peanuts (excipient).
* Grade 2 (or upper) renal or liver laboratory abnormalities
* Treated from dependent-hormone malignant cancer (i.e., breast carcinoma...)
* With Diabetes mellitus or insulinized gestational diabetes
* Treated with heparin
* Drug abuse
* Inadequate treatment compliance

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No