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

Primary Purpose

Threatened Premature Labor

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Progesterone
Placebo
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Threatened Premature Labor

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Sant joan de Déu de Manresa
  • Corporació Sanitària Parc Taulí
  • Hospital de Terrassa. CST
  • Complejo Hospitalario Universitario Insular-Materno Infantil
  • Hospital Son Llàtzer
  • Institut Universitari Dexeus
  • Hospital Clinic de Barcelona
  • Hospital de Basurto
  • Hospital Puerta del Mar
  • Hospital U Gregorio Marañon
  • Hospital Virgen de la Macarena
  • Hospital Clinico U. Lozano Blesa

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A

B

Arm Description

Progesterone 200 mg

Placebo

Outcomes

Primary Outcome Measures

Proportion of deliveries before week 34 of gestation

Secondary Outcome Measures

Median time from randomization to delivery
Ultrasound cervical length

Full Information

First Posted
March 26, 2008
Last Updated
August 18, 2016
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT00646802
Brief Title
Vaginal PROgesterone as Maintenance Treatment After an epISode of prEterm Labor (PROMISE Study)
Acronym
PROMISE
Official Title
Vaginal Progesterone as a Maintenance Treatment in Women With Previous Preterm Labor. Randomized, Double Blinded, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Threatened Premature Labor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
265 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Progesterone 200 mg
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Progesterone
Intervention Description
1 vaginal capsule, 200 mg, once daily since gestation age 36 weeks and 6 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 vaginal capsule, once daily since gestational age of 36 weeks and 6 days
Primary Outcome Measure Information:
Title
Proportion of deliveries before week 34 of gestation
Time Frame
week 34 of gestation
Secondary Outcome Measure Information:
Title
Median time from randomization to delivery
Time Frame
delivery
Title
Ultrasound cervical length
Time Frame
week +5

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Montse Palacio, MD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Sant joan de Déu de Manresa
City
Manresa
State/Province
Barcelona
ZIP/Postal Code
08243
Country
Spain
Facility Name
Corporació Sanitària Parc Taulí
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital de Terrassa. CST
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08227
Country
Spain
Facility Name
Complejo Hospitalario Universitario Insular-Materno Infantil
City
Las Palmas de Gran Canaria
State/Province
Gran Canaria
ZIP/Postal Code
35016
Country
Spain
Facility Name
Hospital Son Llàtzer
City
Palma de Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07198
Country
Spain
Facility Name
Institut Universitari Dexeus
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de Basurto
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital Puerta del Mar
City
Cádiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
Hospital U Gregorio Marañon
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Virgen de la Macarena
City
Seville
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Clinico U. Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain

12. IPD Sharing Statement

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

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