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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Montse Palacio, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00646802
First received: March 26, 2008
Last updated: May 23, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Threatened Premature Labor
Drug: Progesterone
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vaginal Progesterone as a Maintenance Treatment in Women With Previous Preterm Labor. Randomized, Double Blinded, Placebo-controlled Trial

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Proportion of deliveries before week 34 of gestation [ Time Frame: week 34 of gestation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Median time from randomization to delivery [ Time Frame: delivery ] [ Designated as safety issue: No ]
  • Ultrasound cervical length [ Time Frame: week +5 ] [ Designated as safety issue: No ]

Enrollment: 265
Study Start Date: June 2008
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Progesterone 200 mg
Drug: Progesterone
1 vaginal capsule, 200 mg, once daily since gestation age 36 weeks and 6 days
Placebo Comparator: B
Placebo
Drug: Placebo
1 vaginal capsule, once daily since gestational age of 36 weeks and 6 days

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646802

Locations
Spain
Hospital Sant joan de Déu de Manresa
Manresa, Barcelona, Spain, 08243
Corporació Sanitària Parc Taulí
Sabadell, Barcelona, Spain, 08208
Hospital de Terrassa. CST
Terrassa, Barcelona, Spain, 08227
Complejo Hospitalario Universitario Insular-Materno Infantil
Las Palmas de Gran Canaria, Gran Canaria, Spain, 35016
Hospital Son Llàtzer
Palma de Mallorca, Islas Baleares, Spain, 07198
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Institut Universitari Dexeus
Barcelona, Spain, 08028
Hospital de Basurto
Bilbao, Spain, 48013
Hospital Puerta del Mar
Cádiz, Spain, 11009
Hospital U Gregorio Marañon
Madrid, Spain, 28009
Hospital Virgen de la Macarena
Seville, Spain, 41009
Hospital Clinico U. Lozano Blesa
Zaragoza, Spain, 50009
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Principal Investigator: Montse Palacio, MD Hospital Clinic of Barcelona
  More Information

No publications provided

Responsible Party: Montse Palacio, MD, PhD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT00646802     History of Changes
Other Study ID Numbers: PROMISE
Study First Received: March 26, 2008
Last Updated: May 23, 2012
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014