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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00646802
Recruitment Status : Completed
First Posted : March 31, 2008
Last Update Posted : August 19, 2016
Information provided by (Responsible Party):
Montse Palacio, Hospital Clinic of Barcelona

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.

Condition or disease Intervention/treatment Phase
Threatened Premature Labor Drug: Progesterone Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 265 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2008
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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
Drug: Placebo
1 vaginal capsule, once daily since gestational age of 36 weeks and 6 days

Primary Outcome Measures :
  1. Proportion of deliveries before week 34 of gestation [ Time Frame: week 34 of gestation ]

Secondary Outcome Measures :
  1. Median time from randomization to delivery [ Time Frame: delivery ]
  2. Ultrasound cervical length [ Time Frame: week +5 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00646802

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
Institut Universitari Dexeus
Barcelona, Spain, 08028
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
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
Principal Investigator: Montse Palacio, MD Hospital Clinic of Barcelona

Responsible Party: Montse Palacio, MD, PhD, Hospital Clinic of Barcelona Identifier: NCT00646802     History of Changes
Other Study ID Numbers: PROMISE
First Posted: March 31, 2008    Key Record Dates
Last Update Posted: August 19, 2016
Last Verified: August 2016

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