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

Vaginal Progesterone as a Maintenance Treatment in Women With Previous Preterm Labor. Randomized, Double Blinded, Placebo-controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Threatened Premature Labor
• Intervention / Treatment: Drug: Progesterone; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 265
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 08028
    • Institut Universitari Dexeus
  • Bilbao, Spain, 48013
    • Hospital de Basurto
  • Cádiz, Spain, 11009
    • Hospital Puerta del Mar
  • Madrid, Spain, 28009
    • Hospital U Gregorio Marañon
  • Seville, Spain, 41009
    • Hospital Virgen de la Macarena
  • Zaragoza, Spain, 50009
    • Hospital Clinico U. Lozano Blesa
  • Barcelona
    • Manresa, Barcelona, Spain, 08243
      • Hospital Sant Joan de Déu de Manresa
    • Sabadell, Barcelona, Spain, 08208
      • Corporació Sanitària Parc Taulí
    • Terrassa, Barcelona, Spain, 08227
      • Hospital de Terrassa. CST
  • Gran Canaria
    • Las Palmas de Gran Canaria, Gran Canaria, Spain, 35016
      • Complejo hospitalario Universitario Insular-Materno Infantil
  • Islas Baleares
    • Palma de Mallorca, Islas Baleares, Spain, 07198
      • Hospital Son Llàtzer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: B; Placebo	Drug: Placebo; 1 vaginal capsule, once daily since gestational age of 36 weeks and 6 days
Active Comparator: A; Progesterone 200 mg	Drug: Progesterone; 1 vaginal capsule, 200 mg, once daily since gestation age 36 weeks and 6 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of deliveries before week 34 of gestation	week 34 of gestation

Secondary Outcome Measures

Outcome Measure	Time Frame
Median time from randomization to delivery	delivery
Ultrasound cervical length	week +5

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Investigators: Principal Investigator: Montse Palacio, MD, Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: March 26, 2008
• First Submitted That Met QC Criteria: March 26, 2008
• First Posted (Estimate): March 31, 2008

Study Record Updates

• Last Update Posted (Estimate): August 19, 2016
• Last Update Submitted That Met QC Criteria: August 18, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone
• Other Study ID Numbers: PROMISE